Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-24 @ 2:40 PM
Study NCT ID:
NCT04109859
Status:
UNKNOWN
Last Update Posted:
2019-10-01
First Post:
2019-09-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007565', 'term': 'Jaundice'}], 'ancestors': [{'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D008751', 'term': 'Methylene Blue'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-01-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-28', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute physiology and chronic health evaluation IIScore sheet', 'timeFrame': '3 days', 'description': 'use this Score sheet to evaluation of postoperative organ function in patients.The total score is 0 to 71'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Jaundice']}, 'descriptionModule': {'briefSummary': 'Increased production of vasodilating substances such as NO plays an important role in the development of vasoplegic syndrome caused by obstructive jaundice.Methylene blue plays a role in raising blood pressure by inhibiting the vasodilator Nitric Oxide (NO)', 'detailedDescription': 'The level of circulating hydrogen sulfide (H2S) in patients with obstructive jaundice is significantly increased. As a direct opener of KATP channels in vivo, H2S also has diastolic peripheral vasculature . H2S participates in the occurrence of vasoplegic syndrome in patients with obstructive jaundice by interacting with NO. However, it is unclear whether methylene blue can relieve vasoplegic syndrome in patients with obstructive jaundice by inhibiting the vasodilating effect of substances such as H2S and NO.\n\nTherefore, this clinical study intends to include patients with obstructive jaundice, using randomized, controlled, prospective study to explore the effect of methylene blue on the occurrence of vasoplegic syndrome, organ function and prognosis in patients with obstructive jaundice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18\\~70 years old;\n2. ASA grade I\\~III;\n3. Ability to comply with research protocols;\n4. Patients with obstructive jaundice: patients with total bilirubin greater than 50umol/L;\n5. Voluntarily participate in the study and sign the informed consent form. -\n\nExclusion Criteria:\n\n1. ASA IV\\~V grade;\n2. women during lactation and pregnancy;\n3. Patients with severe heart disease or lung disease before surgery;\n4. Participating in other trials in the last 2 months;\n5. Those whose mental state cannot cooperate, who suffer from mental illness, have no self-control, and cannot express clearly;\n6. Those who refuse to sign the informed consent form. -'}, 'identificationModule': {'nctId': 'NCT04109859', 'briefTitle': 'Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice', 'orgStudyIdInfo': {'id': 'KY201999'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylene blue group', 'description': 'Before the anesthesia was intubated, the patients in the methylene blue group were given a 2 mg/Kg methylene blue 50 ml intravenously for 10 min; continuous constant speed pumping methylene blue(0.5mg/Kg/h).', 'interventionNames': ['Drug: Methylene Blue']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Before the anesthesia was intubated, the placebo group was given 50 ml of normal saline for 10 min.continuous constant speed pumpingnormal saline (10ml/h).', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Placebo group'], 'description': 'When using saline, if found mean arterial pressure \\<65mmHg, Cardic Output\\>4L/min, Sequential Vascular Response\\<800 (dyne×sec)/cm, starting dose of norepinephrine 0.04ug/min/kg', 'armGroupLabels': ['Placebo group']}, {'name': 'Methylene Blue', 'type': 'DRUG', 'otherNames': ['Methylene blue group'], 'description': 'Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping', 'armGroupLabels': ['Methylene blue group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Jiaolin Ning, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of department of anesthesia, Southwest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiaolin Ning,MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of department of anesthesia', 'investigatorFullName': 'Jiaolin Ning,MD', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}