Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-26 @ 1:08 AM
Study NCT ID:
NCT02543658
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2015-08-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D050338', 'term': 'Phenylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hewenhua@ncu.edu.cn', 'phone': '+8613879182642', 'title': 'Wenhua He', 'organization': 'First affilitated hospital of Nanchang university'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'The main adverse events observed were the effects of neostigmine on the cardiovascular system, such as arrhythmias and decreased blood pressure', 'eventGroups': [{'id': 'EG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 10, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'The Traditional Treatment', 'description': 'Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 11, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Single cardiovascular failure', 'notes': 'Emerging cardiovascular failure after randomization,', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular and respiratory failure', 'notes': 'Patient has both cardiovascular and respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular and renal failure', 'notes': 'The patient has both cardiovascular and renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular, respiratory and renal failure', 'notes': 'The patient has both cardiovascular, respiratory and renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change of IAP After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'title': 'percent change of IAP at 24 hours', 'categories': [{'measurements': [{'value': '-18.7', 'groupId': 'OG000', 'lowerLimit': '-28.4', 'upperLimit': '-4.7'}, {'value': '-5.4', 'groupId': 'OG001', 'lowerLimit': '-18.0', 'upperLimit': '0'}]}]}, {'title': 'percent change of IAP at 7 days', 'categories': [{'measurements': [{'value': '-27.2', 'groupId': 'OG000', 'lowerLimit': '-39.4', 'upperLimit': '-5.3'}, {'value': '-20.0', 'groupId': 'OG001', 'lowerLimit': '-26.7', 'upperLimit': '-5.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to 7 days after treatment,Measured IAP every 6 hours', 'description': 'Monitor the intra-abdominal pressure within 1 to 7 days after randomization, and calculate the percent change compared with that before randomization', 'unitOfMeasure': 'percent change of IAP', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary outcome measure was decreased rate of IAP after randomisation.'}, {'type': 'SECONDARY', 'title': 'The Change of Stool Volume at 1-7 Days After Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'title': 'The change of stool volume at 24 hours', 'categories': [{'measurements': [{'value': '870', 'groupId': 'OG000', 'lowerLimit': '250', 'upperLimit': '2070'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '-30', 'upperLimit': '770'}]}]}, {'title': 'The change of stool volume at 7th day', 'categories': [{'measurements': [{'value': '1025', 'groupId': 'OG000', 'lowerLimit': '450', 'upperLimit': '1520'}, {'value': '370', 'groupId': 'OG001', 'lowerLimit': '150', 'upperLimit': '1200'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to 7 days', 'description': 'After randomization, the change of stool volume (ML) was calculated every 24 hours.For example, the amount of stool volume decreased or increased in 24 hours after grouping compared to before grouping.', 'unitOfMeasure': 'ml/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'New-onset Abdominal Compartment Syndrom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to discharge or death, assessed up to 4 weeks', 'description': 'Abdominal compartment syndrome is defined as a sustained IAP\\>20 mmHg (with or without an APP\\<60 mmHg) that is associated with new organ dysfunction/failure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'New-onset Organ Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to discharge or death, assessed up to 3 months', 'description': 'Incidence of organ failure from randomization to discharge or death, assessed up to 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death of 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to 90 days after onset.', 'description': 'Death during from randomization to 90 days after onset.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Timing of Enteral Nutrition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Start time of enteral nutrition after randomization, assessed up to 30 days', 'description': 'From date of randomization to enteral nutrition, assessed up to 30 days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Deterioration of IAH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to 7 days', 'description': 'IAP rebound ≥ 5mmHg or increase ≥ 20mmHg within 1-7 days after grouping', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Effects on the Cardiovascular System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to 7 days', 'description': 'Due to that neostigmine has an inhibitory effect on the cardiovascular system, new-onset cardiovascular failure after grouping is considered as a possible adverse event related to neostigmine.Cardiovascular failure was defined as circulatory systolic blood pressure \\<90 mm Hg, despite adequate fluid resuscitation, or need for inotropic catecholamine support', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Days in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '31'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation to 6 months', 'description': 'Days in hospital within 6 months after randomisation', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Days in ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '19'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation to 6 months', 'description': 'Days in ICU within 6 months after randomisation', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Medical Expenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'OG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '146.8'}, {'value': '102.3', 'groupId': 'OG001', 'lowerLimit': '56.0', 'upperLimit': '186.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation to 6 months', 'description': 'Medical expenses within 6 months after randomisation', 'unitOfMeasure': 'thousand(RMB)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.'}, {'id': 'FG001', 'title': 'The Traditional Treatment', 'description': 'Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Between Sept 1, 2015, and Aug 15, 2017, we measured intra-abdominal pressure on patients with acute pancreatitis and selected patients with intra-abdominal hypertension, in the Pancreatic Intensive Care Unit of the Department of Gastroenterology, the First Affiliated Hospital of Nanchang University.', 'preAssignmentDetails': 'Acute pancreatitis patients with intra-abdominal hypertension were first treated with conventional non-surgical therapy(such as: Enteral decompression with nasogastric and rectal tube,Glycerin enema, percutaneous drainage of ascites) for 24 hours. After 24 hours, the intra-abdominal pressure was still above 12 mmHg and they were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment\n\nNeostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days.\n\nConservative treatment: Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'BG001', 'title': 'Conservative Treatment', 'description': 'Intragastric administration of paraffin oil, 50ml, Q8H, gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation.; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '13', 'groupId': 'BG000'}, {'value': '49', 'spread': '14', 'groupId': 'BG001'}, {'value': '48', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'yeas', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cause of pancreatitis', 'classes': [{'categories': [{'title': 'Biliary', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Hyperlipidemic', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Alcoholic', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Idiopathic', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 80 out of 186 patients were included'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-02', 'size': 265359, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-04T07:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-02', 'studyFirstSubmitDate': '2015-08-27', 'resultsFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-03', 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Days in Hospital', 'timeFrame': 'From randomisation to 6 months', 'description': 'Days in hospital within 6 months after randomisation'}, {'measure': 'Days in ICU', 'timeFrame': 'From randomisation to 6 months', 'description': 'Days in ICU within 6 months after randomisation'}, {'measure': 'Medical Expenses', 'timeFrame': 'From randomisation to 6 months', 'description': 'Medical expenses within 6 months after randomisation'}], 'primaryOutcomes': [{'measure': 'Percent Change of IAP After Treatment', 'timeFrame': 'From randomization to 7 days after treatment,Measured IAP every 6 hours', 'description': 'Monitor the intra-abdominal pressure within 1 to 7 days after randomization, and calculate the percent change compared with that before randomization'}], 'secondaryOutcomes': [{'measure': 'The Change of Stool Volume at 1-7 Days After Randomization', 'timeFrame': 'From randomization to 7 days', 'description': 'After randomization, the change of stool volume (ML) was calculated every 24 hours.For example, the amount of stool volume decreased or increased in 24 hours after grouping compared to before grouping.'}, {'measure': 'New-onset Abdominal Compartment Syndrom', 'timeFrame': 'From randomization to discharge or death, assessed up to 4 weeks', 'description': 'Abdominal compartment syndrome is defined as a sustained IAP\\>20 mmHg (with or without an APP\\<60 mmHg) that is associated with new organ dysfunction/failure'}, {'measure': 'New-onset Organ Failure', 'timeFrame': 'From randomization to discharge or death, assessed up to 3 months', 'description': 'Incidence of organ failure from randomization to discharge or death, assessed up to 3 months'}, {'measure': 'Death of 90 Days', 'timeFrame': 'From randomization to 90 days after onset.', 'description': 'Death during from randomization to 90 days after onset.'}, {'measure': 'Timing of Enteral Nutrition', 'timeFrame': 'Start time of enteral nutrition after randomization, assessed up to 30 days', 'description': 'From date of randomization to enteral nutrition, assessed up to 30 days'}, {'measure': 'Number of Participants With Deterioration of IAH', 'timeFrame': 'From randomization to 7 days', 'description': 'IAP rebound ≥ 5mmHg or increase ≥ 20mmHg within 1-7 days after grouping'}, {'measure': 'Number of Participants With Adverse Effects on the Cardiovascular System', 'timeFrame': 'From randomization to 7 days', 'description': 'Due to that neostigmine has an inhibitory effect on the cardiovascular system, new-onset cardiovascular failure after grouping is considered as a possible adverse event related to neostigmine.Cardiovascular failure was defined as circulatory systolic blood pressure \\<90 mm Hg, despite adequate fluid resuscitation, or need for inotropic catecholamine support'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Pancreatitis', 'Intra-abdominal hypertension', 'Abdominal compartment syndrome', 'Curative Effect', 'Security', 'Neostigmine'], 'conditions': ['Acute Pancreatitis', 'Intra-abdominal Hypertension']}, 'referencesModule': {'references': [{'pmid': '23100216', 'type': 'BACKGROUND', 'citation': 'Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.'}, {'pmid': '18520642', 'type': 'BACKGROUND', 'citation': 'Vidal MG, Ruiz Weisser J, Gonzalez F, Toro MA, Loudet C, Balasini C, Canales H, Reina R, Estenssoro E. Incidence and clinical effects of intra-abdominal hypertension in critically ill patients. Crit Care Med. 2008 Jun;36(6):1823-31. doi: 10.1097/CCM.0b013e31817c7a4d.'}, {'pmid': '23476830', 'type': 'BACKGROUND', 'citation': 'Kasi PM. The use of intravenous neostigmine in palliation of severe ileus. Case Rep Gastrointest Med. 2013;2013:796739. doi: 10.1155/2013/796739. Epub 2013 Feb 14.'}, {'pmid': '12490958', 'type': 'BACKGROUND', 'citation': 'Tracey KJ. The inflammatory reflex. Nature. 2002 Dec 19-26;420(6917):853-9. doi: 10.1038/nature01321.'}, {'pmid': '10839541', 'type': 'BACKGROUND', 'citation': 'Borovikova LV, Ivanova S, Zhang M, Yang H, Botchkina GI, Watkins LR, Wang H, Abumrad N, Eaton JW, Tracey KJ. Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin. Nature. 2000 May 25;405(6785):458-62. doi: 10.1038/35013070.'}, {'pmid': '24212240', 'type': 'BACKGROUND', 'citation': 'Schneider L, Jabrailova B, Soliman H, Hofer S, Strobel O, Hackert T, Buchler MW, Werner J. Pharmacological cholinergic stimulation as a therapeutic tool in experimental necrotizing pancreatitis. Pancreas. 2014 Jan;43(1):41-6. doi: 10.1097/MPA.0b013e3182a85c21.'}, {'pmid': '18026931', 'type': 'BACKGROUND', 'citation': 'Shaikh N, Kettern MA, Hanssens Y, Elshafie SS, Louon A. A rare and unsuspected complication of Clostridium difficile infection. Intensive Care Med. 2008 May;34(5):963-6. doi: 10.1007/s00134-007-0922-6. Epub 2007 Nov 20.'}, {'pmid': '23673399', 'type': 'BACKGROUND', 'citation': "Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15."}, {'pmid': '24921201', 'type': 'BACKGROUND', 'citation': 'van Brunschot S, Schut AJ, Bouwense SA, Besselink MG, Bakker OJ, van Goor H, Hofker S, Gooszen HG, Boermeester MA, van Santvoort HC; Dutch Pancreatitis Study Group. Abdominal compartment syndrome in acute pancreatitis: a systematic review. Pancreas. 2014 Jul;43(5):665-74. doi: 10.1097/MPA.0000000000000108.'}, {'pmid': '25062870', 'type': 'BACKGROUND', 'citation': 'Trikudanathan G, Vege SS. Current concepts of the role of abdominal compartment syndrome in acute pancreatitis - an opportunity or merely an epiphenomenon. Pancreatology. 2014 Jul-Aug;14(4):238-43. doi: 10.1016/j.pan.2014.06.002. Epub 2014 Jun 17.'}, {'pmid': '10403850', 'type': 'BACKGROUND', 'citation': 'Ponec RJ, Saunders MD, Kimmey MB. Neostigmine for the treatment of acute colonic pseudo-obstruction. N Engl J Med. 1999 Jul 15;341(3):137-41. doi: 10.1056/NEJM199907153410301.'}, {'pmid': '35241135', 'type': 'DERIVED', 'citation': 'He W, Chen P, Lei Y, Xia L, Liu P, Zhu Y, Zeng H, Wu Y, Ke H, Huang X, Cai W, Sun X, Huang W, Sutton R, Zhu Y, Lu N. Randomized controlled trial: neostigmine for intra-abdominal hypertension in acute pancreatitis. Crit Care. 2022 Mar 3;26(1):52. doi: 10.1186/s13054-022-03922-4.'}]}, 'descriptionModule': {'briefSummary': 'Acute pancreatitis(A) often complicated with Intra-abdominal Hypertension. After the onset of acute pancreatitis, capillary leakage causing ascites,upper gastrointestinal tract obstruction and paralytic ileus leading to an elevated IAP, severe IAH leads to ACS with high mortality. Neostigmine is an anti-cholinesterase drugs, can enhance intestinal peristalsis, promote flatus defecation. The aim of this study was to determine the effect of neostigmine on reducing abdominal pressure and clinical prognosis in patients with AP by promoting intestinal peristalsis and defecation.', 'detailedDescription': 'Acute pancreatitis(AP) runs a severe course in around 20% of patients and is associated with a mortality up to 30%. Intra-abdominal hypertension(IAH）is a common complication of severe acute pancreatitis(SAP). The inflammation of the pancreas starts a cascade of pancreatic and visceral edema, acute peripancreatic fluid collections, capillary leakage causing ascites, paralytic ileus, and gastric dilatation by upper gastrointestinal tract obstruction leading to an elevated intra-abdominal pressure (IAP). A sustained or repeated pathological elevation in IAP ≥12 mmHg is defined as IAH, it generally occurs often within the first week after onset of SAP. Persistent and serious IAH (IAP \\>20 mmHg ) often leads to new onset organ failure or acute worsening of existing organ failure, which is defined as ACS and associated with a mortality rate of 49%.\n\nIn the past practice, many patients with ACS undergo decompressive laparotomy, which obviously has a risk of complications. Therefore, numerous medical, nonmedical, and minimally invasive therapies have been introduced. Neostigmine is an anti-cholinesterase drugs, can enhance intestinal peristalsis, promote flatus defecation. World Society for Abdominal Compartment Syndrome (WSACS)guidelines,suggest that neostigmine be used for the treatment of established colonic ileus not responding to other simple measures and associated with IAH.However, no data exist on the effects of pharmacologic promotility therapy on IAP or outcomes among those with IAH/ACS. The aim of this study was to evaluate the efficacy of neostigmine on reducing IAP in AP patients with IAH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-70 year ;\n2. The diagnosis of acute pancreatitis according to the revised Atlanta classification.\n3. IAH is defined as IAP ≥ 12 mmHg by the World Society of Abdominal;Compartment Syndrome (WSACS);\n4. After 24 hours of conventional treatment(such as gastrointestinal decompression or percutaneous drainage of ascites), the IAP of AP patients with IAH was still ≥ 12 mmHg;\n5. The onset time of acute pancreatitis was within 2 weeks;\n6. Signed the informed consent.\n\nExclusion Criteria:\n\n1. Previous history of laparotomy;\n2. Mechanical ileus or abdominal hemorrhage were considered clinically;\n3. Those who have contraindications to neostigmine: 1) Patients with angina; 2) myocardial infarction; 3) ventricular tachycardia; 4) bradycardia; 5) acute circulatory failure; 6) epilepsy; 7) bronchial asthma; 8) mechanical intestinal obstruction; 9) urinary tract infarction; 10) hyperthyroidism; 11) serious arrhythmia; 12) bladder operation; 13) intestinal fistula;\n4. Allergic to neostigmine;\n5. Pregnant or lactating patients.'}, 'identificationModule': {'nctId': 'NCT02543658', 'briefTitle': 'Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Nanchang University'}, 'officialTitle': 'The Curative Effect and Security of Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension', 'orgStudyIdInfo': {'id': 'FAHONCU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neostigmine', 'description': 'Intramuscular injection of neostigmine on the basis of conventional conservative treatment', 'interventionNames': ['Drug: Neostigmine Methylsulfate 1 MG/ML', 'Combination Product: Conservative treatment']}, {'type': 'OTHER', 'label': 'Conservative treatment', 'description': 'Intragastric administration of paraffin oil, 50ml,once every 8 hours；gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.', 'interventionNames': ['Combination Product: Conservative treatment']}], 'interventions': [{'name': 'Neostigmine Methylsulfate 1 MG/ML', 'type': 'DRUG', 'otherNames': ['Prostigmin'], 'description': 'The initial dose was 1mg, intramuscular injection(IM) once every 12 hours. If there is no defecation after 12 hours, the dose is increased to 1mg IM once every 8 hours; if there is no defecation after 24 hours, the dose is increased to 1mg IM once every 6 hours. If the abdominal pressure drops below 12mmhg, neostigmine will be stopped, otherwise it will be used continuously for 7 days.', 'armGroupLabels': ['Neostigmine']}, {'name': 'Conservative treatment', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Non-surgical treatment'], 'description': 'Intragastric administration of paraffin oil, 50ml,once every 8 hours；gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.', 'armGroupLabels': ['Conservative treatment', 'Neostigmine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'overallOfficials': [{'name': 'Nonghua Lv, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'the Frist Affiliated Hospital of Nanchang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician-in-charge', 'investigatorFullName': 'Lingyu Luo', 'investigatorAffiliation': 'The First Affiliated Hospital of Nanchang University'}}}}