Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-02 @ 12:37 AM
Study NCT ID:
NCT03634566
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of N_Acetylcysteine on Liver Functions in Donors in Living Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-30', 'studyFirstSubmitDate': '2018-08-13', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum lactate', 'timeFrame': '24 hours postoperative'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant; Complications']}, 'descriptionModule': {'briefSummary': "our practice for the past 10 years we have noticed a transitional impairment of liver function (elevated liver enzymes, total and direct bilirubin, and elevated serum lactate levels) following donors' liver resection. Several drugs have been investigation on liver regeneration , proven benefit of N-Acetylcysteine (NAC) on rats with steatohpatitis"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I or II donors\n* healthy adult\n\nExclusion Criteria:\n\n* kidney, liver disease\n* any contraindications for organ donation'}, 'identificationModule': {'nctId': 'NCT03634566', 'briefTitle': 'Effect of N_Acetylcysteine on Liver Functions in Donors in Living Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of N_Acetylcysteine on Liver Functions in Donors in Living Donor Liver Transplantation', 'orgStudyIdInfo': {'id': 'R 10/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NAC group', 'description': 'Group NC received NAC 150 mg/kg diluted in 100 ml glucose 5 % over 40 minutes followed by NAC 12.5 mg/kg in 500 ml glucose 5% over 4 hours, followed by NAC 6.25 mg/kg for 2 postoperative days', 'interventionNames': ['Drug: N-Acetylecysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Group C (Control group) will receive ringer acetate continuous infusion at same rate for 2 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'N-Acetylecysteine', 'type': 'DRUG', 'description': 'N-Acetylecysteine 150 mg/kg diluted in 100 ml glucose 5 % over 40 minutes followed by NAC 12.5 mg/kg in 500 ml glucose 5% over 4 hours, followed by NAC 6.25 mg/kg for 2 postoperative days', 'armGroupLabels': ['NAC group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Ringer acetate continuous infusion at the same rate for 2 days.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia,intensive care and pain management', 'investigatorFullName': 'Mona Ammar', 'investigatorAffiliation': 'Ain Shams University'}}}}