Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-26 @ 10:51 PM
Study NCT ID:
NCT01998334
Status:
UNKNOWN
Last Update Posted:
2013-11-28
First Post:
2013-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079664', 'term': 'Continuous Renal Replacement Therapy'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-23', 'studyFirstSubmitDate': '2013-11-10', 'studyFirstSubmitQcDate': '2013-11-23', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ICU and hospital duration', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 8 weeks'}], 'primaryOutcomes': [{'measure': 'The Efficiency of CBP with Inflammatory Response', 'timeFrame': '3 days', 'description': 'Efficiency of CBP with inflammatory response was assessed by the following measurements:\n\n1. Inflammatory mediators removal:tumor necrosis factor-α, interleukin(IL-1, IL-2, IL-6, and IL-8, IL-10, sIL-2R)before and after CBP in first three days\n2. SIRS parameters variation: (Heart rate, respiratory rate, White Blood Cell, Temperature, C response protein) before and after CBP in first three days'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '28 days', 'description': 'Mortality of 28 days'}, {'measure': 'operation time', 'timeFrame': '28 days', 'description': 'operation time of 28 days'}, {'measure': 'local complication of severe acute pancreatitis', 'timeFrame': '28 days', 'description': 'local complication of SAP in 28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Systemic Inflammatory Response Syndrome', 'Continuous Blood Purification'], 'conditions': ['Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'Systemic Inflammatory response syndrome(SIRS) is common in patients with severe acute pancreatitis (SAP) in early stage. Continuous Blood Purification (CBP), especially Continuous Veno-Venous Hemofiltration(CVVH) is proved to have an important role in SAP patients to control SIRS. But the detail treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three kinds of treatment protocols which is CVVH 6h,continuous venovenous hemodiafiltration(CVVHDF) 6h,CVVH 10h for first three days in SAP patients. Compare the vital sign, SIRS parameters, and others between these three groups. This study will try to find a better way for CBP in patients with SAP', 'detailedDescription': 'Condition Severe Acute Pancreatitis\n\nIntervention CVVH 6 hours for first three days CVVH 10 hours for first three days CVVHDF 6 hours for first three days\n\nAll therapeutic volume is 45ml/kg.h, Device: Braxter HF 1200'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria:\n\n1. Diagnosis of pancreatitis:\n\n * Typical pain\n * Increase in serum lipase or amylase\n * Onset of abdominal pain within \\<=72h before admission\n2. The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012\n3. no chronic diseases such as Chronic Obstructive Pulmonary Disease, Diabetes Mellitus and so on\n4. Age from 18 to 65 years old\n\nBesides criteria above, the patient should also satisfied one of these CBP criteria:\n\n1. Have Acute Kidney Injury satisfied RIFLE classification (risk above): increased Serum Creatinine \\> 1.5 times baseline，26.5umol/L increase, or urine output \\< 0.5ml/kg.h for 6 hours\n2. Systemic Inflammatory Response Syndrome: temperature \\>38℃ or\\<36℃；heart rate respiratory rate White blood cell count \\>12\\*10\\^9/L，or\\< 4\\*10\\^9/L\n3. Refractory acid-base and electrocyte balance disorder, metabolic acidosis conservative treatment is not effective.\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Chronic pancreatitis\n3. Immunosuppression condition such as HIV, Corticosteroid for 3 weeks in 60 days; White Blood Cell \\< 0.5\\*10\\^9/L for 10 days'}, 'identificationModule': {'nctId': 'NCT01998334', 'briefTitle': 'Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis', 'orgStudyIdInfo': {'id': 'SAP BUNDLE-CRRT'}, 'secondaryIdInfos': [{'id': '12411950500', 'type': 'OTHER_GRANT', 'domain': 'Science and Technology Commission of Shanghai Municipality'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CVVH 6h', 'description': 'CVVH 6h for first three days', 'interventionNames': ['Other: CVVH 6h']}, {'type': 'EXPERIMENTAL', 'label': 'CVVH 10h', 'description': 'CVVH 10h for first three days', 'interventionNames': ['Other: CVVH 10h']}, {'type': 'EXPERIMENTAL', 'label': 'CVVHDF', 'description': 'CVVHDF 6h for first three days', 'interventionNames': ['Other: CVVHDF 6h']}], 'interventions': [{'name': 'CVVH 6h', 'type': 'OTHER', 'description': 'CVVH 6h for first three days', 'armGroupLabels': ['CVVH 6h']}, {'name': 'CVVH 10h', 'type': 'OTHER', 'description': 'CVVH 10h for first three days', 'armGroupLabels': ['CVVH 10h']}, {'name': 'CVVHDF 6h', 'type': 'OTHER', 'description': 'CVVHDF 6h for first three days', 'armGroupLabels': ['CVVHDF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Erzhen Chen, M.D', 'role': 'CONTACT', 'phone': '86-13901753478'}, {'name': 'Enqiang Mao, M.D', 'role': 'CONTACT', 'phone': '13501747906'}, {'name': 'Jingyi Wu, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Erzhen Chen, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of EICU, Ruijin Hospital,', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Enqiang Mao, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of EICU Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'RenJi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Erzhen Chen', 'investigatorAffiliation': 'Ruijin Hospital'}}}}