Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT00736866
Status:
COMPLETED
Last Update Posted:
2010-07-12
First Post:
2008-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Acetylcysteine for Contrast-Induced Nephropathy Trial
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-08', 'studyFirstSubmitDate': '2008-08-14', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast-induced nephropathy incidence', 'timeFrame': 'between 48 and 96 hours after angiographic procedures'}], 'secondaryOutcomes': [{'measure': 'Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication', 'timeFrame': 'within 30 days'}, {'measure': 'Combined outcome of total mortality or dialysis indication', 'timeFrame': 'within 30 days'}, {'measure': 'The individual components of the combined outcome', 'timeFrame': 'within 30 dias'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acetylcysteine', 'contrast-induced nephropathy', 'angiography', 'angioplasty with or without Stent'], 'conditions': ['Acute Kidney Failure']}, 'referencesModule': {'references': [{'pmid': '23572490', 'type': 'DERIVED', 'citation': 'Berwanger O, Cavalcanti AB, Sousa AM, Buehler A, Castello-Junior HJ, Cantarelli MJ, Mangione JA, Bergo RR, Sao Thiago LE, Nunes PM, da Motta PA, Kodama A, Victor E, Carvalho VO, Sousa JE; Acetylcysteine for Contrast-Induced Nephropathy Trial Investigators. Acetylcysteine for the prevention of renal outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography: a substudy of the acetylcysteine for contrast-induced nephropathy trial. Circ Cardiovasc Interv. 2013 Apr;6(2):139-45. doi: 10.1161/CIRCINTERVENTIONS.112.000149. Epub 2013 Apr 9.'}, {'pmid': '21859972', 'type': 'DERIVED', 'citation': 'ACT Investigators. Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT). Circulation. 2011 Sep 13;124(11):1250-9. doi: 10.1161/CIRCULATIONAHA.111.038943. Epub 2011 Aug 22.'}, {'pmid': '19497091', 'type': 'DERIVED', 'citation': 'ACT Trial Investigators. Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy. Trials. 2009 Jun 4;10:38. doi: 10.1186/1745-6215-10-38.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast.\n\nContrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAt least one of the following criteria:\n\n* Aged more than 70 years-old\n* Chronic renal failure (defined as serum creatinine higher than 1.5mg/dL within the last 3 months)\n* Diabetes mellitus\n* Congestive heart failure or ventricular disfunction (left ventricular ejection fraction less than 0.45)\n* Shock or intra-aortic balloon pump use\n* Urgency or emergency procedures\n\nExclusion Criteria:\n\n* Pregnant women, breastfeeding or aged below 45 years-old and with no efficacious contraceptive methods.\n* Patients in dialysis\n* Previous inclusion in this trial\n* Patient refusal to informed consent\n* Pacientes com Infarto Agudo do Miocárdio com supradesnivelamento do segmento S-T nos quais não seja possível administrar o protocolo de hidratação pré e pós-procedimento.'}, 'identificationModule': {'nctId': 'NCT00736866', 'acronym': 'ACT', 'briefTitle': 'The Acetylcysteine for Contrast-Induced Nephropathy Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Coracao'}, 'officialTitle': 'A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy', 'orgStudyIdInfo': {'id': 'IEP- HCor 001/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetylcysteine', 'interventionNames': ['Drug: Acetylcysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Acetylcysteine', 'type': 'DRUG', 'description': 'Acetylcysteine: 1200 mg every 12 hours for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.', 'armGroupLabels': ['Acetylcysteine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo of Acetylcysteine: every 12 hours PO, for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04004030', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital do Coração', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Eduardo Sousa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital do Coracao'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Coracao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medley Pharmaceutical Industry SA', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Otavio Berwanger', 'oldOrganization': 'Hospital do Coracao'}}}}