Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 4:22 PM
Study NCT ID:
NCT00190034
Status:
SUSPENDED
Last Update Posted:
2009-02-09
First Post:
2005-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'opposite result', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2007-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.'}]}, 'conditionsModule': {'keywords': ['Acetylcysteine', 'cardiac surgery', 'cardiopulmonary bypass', 'acute renal insufficiency'], 'conditions': ['Cardiovascular Disease', 'Renal Insufficiency, Acute', 'Cardiopulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.', 'detailedDescription': 'BACKGROUND Reactive oxygen species have been shown to cause contrast-induced nephrotoxicity (CIN). According to previous studies, the N-acetylcysteine has been proved to be advantageous in the avoidance of CIN. We seek to evaluate the efficacy of the antioxidant N-acetylcysteine in limiting the nephrotoxicity after cardiovascular surgery with cardiopulmonary bypass.\n\nMETHODS We will prospectively study 60 patients who will receive a cardiovascular surgery with cardiopulmonary bypass. Patients will be randomly assigned to receive either N-acetylcysteine (600 mg orally twice daily for 4 doses) with 0.45% saline intravenously, before and after cardiopulmonary bypass, or placebo with 0.45% saline. Serum creatinine and blood urea nitrogen will be measured before, 48 h and 5 days after the operation procedure.\n\nExpected results Prophylactic oral administration of the antioxidant N-acetylcysteine, along with hydration, will significantly reduce the acute renal damage induced by CPB in patients with chronic renal insufficiency that need cardiovascular procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who will received cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n1. Dialyzed patients\n2. Acute renal failure\n3. Advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%.\n4. Acute chronic obstructive lung disease or asthma exacerbation\n5. Allergy to N-acetylcysteine'}, 'identificationModule': {'nctId': 'NCT00190034', 'briefTitle': 'Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.', 'orgStudyIdInfo': {'id': 'FEMH-93010'}, 'secondaryIdInfos': [{'id': 'FEMH-93-C-030'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'N-Acetylcysteine 600mg/tab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '220', 'city': 'Banqiao District', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}], 'overallOfficials': [{'name': 'Shao-jung Li, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Far Eastern Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Synmosa Biopharma Corp.', 'class': 'INDUSTRY'}]}}}