Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT00122018
Status:
COMPLETED
Last Update Posted:
2014-11-07
First Post:
2005-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D018818', 'term': 'Fenoldopam'}], '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'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-06', 'studyFirstSubmitDate': '2005-07-14', 'studyFirstSubmitQcDate': '2005-07-20', 'lastUpdatePostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of post-operative hospital stay', 'timeFrame': '30-day'}, {'measure': 'Length of post-operative critical care stay', 'timeFrame': '30-day'}, {'measure': 'Creatinine clearance post-operative days 3, 14, and nadir', 'timeFrame': '14 day'}], 'secondaryOutcomes': [{'measure': 'Days to post-operative creatinine clearance nadir', 'timeFrame': '14 day'}, {'measure': 'Intraoperative and post-operative pressor use (pressor-hours)', 'timeFrame': '48 hour'}, {'measure': 'Hospital costs', 'timeFrame': '30-day'}, {'measure': 'Mortality', 'timeFrame': '30-day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Kidney failure', 'Cardiac Surgery', 'Fenoldopam', 'N-acetylcysteine'], 'conditions': ['Kidney Failure, Acute', 'Kidney Failure, Chronic', 'Cardiac Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '18434903', 'type': 'RESULT', 'citation': 'Barr LF, Kolodner K. N-acetylcysteine and fenoldopam protect the renal function of patients with chronic renal insufficiency undergoing cardiac surgery. Crit Care Med. 2008 May;36(5):1427-35. doi: 10.1097/CCM.0b013e31816f48ba.'}, {'pmid': '39607014', 'type': 'DERIVED', 'citation': 'Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.', 'detailedDescription': 'This is a randomized, double-blinded, placebo-controlled trial to evaluate fenoldopam and N-acetylcysteine (NAC) individually, and together, as renal protective agents for patients with renal insufficiency undergoing heart surgery. Subjects have chronic renal insufficiency with creatinine clearance (CrCl) \\</= 40cc/min but not on pre-operative dialysis, and receive: NAC 600 mg by mouth (po) twice a day (bid) or placebo starting 24 hours pre-operative and continuing through the day of surgery; and/or fenoldopam 0.1 mcg/kg/min intravenous (IV) or saline placebo at anesthetic induction and continuing for 48 hours. Outcome data include: nadir, post-operative day 3 and post-operative day 14 CrCl, time to CrCl nadir, length of Intensive Care Unit (ICU) stay, length of post-operative hospital stay, hospital costs, mortality, and the need for hemodialysis. Intraoperative and post-operative pressor use is being monitored. The enrollment will include 80 patients (20 in each group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic creatinine clearance \\</= 40cc/h\n* Pre-operative cardiac surgery\n\nExclusion Criteria:\n\n* Pre-operative ongoing dialysis\n* Nausea and vomiting\n* Uncontrolled glaucoma\n* Allergy to metabisulfite\n* Enrollment in another clinical study within 30 days\n* Pregnancy\n* Acute renal failure'}, 'identificationModule': {'nctId': 'NCT00122018', 'briefTitle': 'An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Pulmonary Critical Care Associates of Baltimore'}, 'officialTitle': 'N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.', 'orgStudyIdInfo': {'id': 'REPORT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAC', 'description': 'N-acetylcysteine started day prior to surgery, continued through night of surgery', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'EXPERIMENTAL', 'label': 'fenoldopam', 'description': 'fenoldopam started at surgery continued for 24 hours', 'interventionNames': ['Drug: fenoldopam']}, {'type': 'EXPERIMENTAL', 'label': 'NAC and fenoldopam', 'description': 'Both N-acetylcysteine and fenoldopam as above', 'interventionNames': ['Drug: N-acetylcysteine', 'Drug: fenoldopam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo'}], 'interventions': [{'name': 'N-acetylcysteine', 'type': 'DRUG', 'otherNames': ['Mucomyst'], 'armGroupLabels': ['NAC', 'NAC and fenoldopam']}, {'name': 'fenoldopam', 'type': 'DRUG', 'otherNames': ['Corlopam'], 'armGroupLabels': ['NAC and fenoldopam', 'fenoldopam']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Linda F Barr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonary and Critical Care Assoc. of Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linda F. Barr, M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Linda F. Barr, M.D.', 'investigatorAffiliation': 'Pulmonary Critical Care Associates of Baltimore'}}}}