Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2026-01-10 @ 9:04 PM
Study NCT ID:
NCT01907061
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2012-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Renal Failure Post Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-20', 'studyFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2013-07-22', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period', 'timeFrame': '6 months', 'description': 'Cytokines in patients receiving N-acetylcysteine versus those receiving placebo during liver transplantation will be compared.'}], 'secondaryOutcomes': [{'measure': 'To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection', 'timeFrame': '6 months', 'description': 'F2-isoprostanes levels in the two groups will be compared to evaluate the role in acute renal failure and acute rejection in patients recieving a liver transplant'}, {'measure': 'iTo determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation', 'timeFrame': '6 months', 'description': 'N-acetylcysteine or placebo will be given to patients recieving a liver tranplant cytokines and oxidative stress markers will be compared between the two groups to determine if N-acetylcysteine will impact acute renal failure post liver transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute renal failure', 'post liver transplant'], 'conditions': ['Acute Renal Failure']}, 'descriptionModule': {'briefSummary': 'Trial to test the effect of administering N-acetylcysteine on cytokines and markers of oxidant stress and the incidence of acute renal failure post liver tranplant', 'detailedDescription': '1. To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period\n2. To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection\n3. To determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First liver transplant\n* Normal renal function before transplantation \\[serum creatinine ≤ 1.5 mg / dl\\]\n* No requirements for dialysis before transplantation\n* Age greater than 18 years\n\nExclusion Criteria:\n\n* Re-transplant\n* Renal dysfunction i.e. serum creatinine \\> 1.5 mg/dl\n* Need for dialysis before transplantation\n* Presence of Hepatorenal or Hepatopulmonary syndrome\\*\n* Combined liver and kidney transplant\n* Peptic ulcer disease\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01907061', 'briefTitle': 'Acute Renal Failure Post Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress', 'orgStudyIdInfo': {'id': '007-157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '600 mg N-acetylcysteine or placebo IV', 'description': '600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion,', 'interventionNames': ['Drug: N-acetylcysteine', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '600 mg N-acetylcysteine or placebo NG', 'description': '600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion,', 'interventionNames': ['Drug: N-acetylcysteine', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'N-acetylcysteine or placebo q 12 hour', 'description': '600 mg NAC or placebo administered via NG tube every 12 hrs + 30 min for 3 additional doses (at 24, 36 and 48 hrs post O.R. infusion). The total administration will be 3000 mg over a 48 hr period.', 'interventionNames': ['Drug: N-acetylcysteine', 'Drug: Placebo']}], 'interventions': [{'name': 'N-acetylcysteine', 'type': 'DRUG', 'otherNames': ['NAC'], 'description': 'drug will be administered via IV,NG', 'armGroupLabels': ['600 mg N-acetylcysteine or placebo IV', '600 mg N-acetylcysteine or placebo NG', 'N-acetylcysteine or placebo q 12 hour']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo in place of NAC'], 'description': 'placebo or NAC will be given', 'armGroupLabels': ['600 mg N-acetylcysteine or placebo IV', '600 mg N-acetylcysteine or placebo NG', 'N-acetylcysteine or placebo q 12 hour']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Yousri M. Barri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor Health Care System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}