Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-01-01 @ 12:35 AM
Study NCT ID:
NCT00579995
Status:
TERMINATED
Last Update Posted:
2023-09-21
First Post:
2007-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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'}, {'id': 'D017693', 'term': 'Sodium Bicarbonate'}], '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': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sshurmur@unmc.edu', 'phone': '402-559-6463', 'title': 'Scott Shurmur, M.D.', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data. Rate of 72 hour Creatinine determination was poor.'}}, 'adverseEventsModule': {'timeFrame': '5 years', 'eventGroups': [{'id': 'EG000', 'title': '1, N-Acetylcysteine', 'description': 'Oral N-acetylcysteine 600 mg', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2, Sodium Bicarbonate', 'description': '3mL/kg/hr for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1, N-Acetylcysteine', 'description': 'N-Acetylcysteine - 600 milligram (mg)'}, {'id': 'OG001', 'title': '2, Sodium Bicarbonate', 'description': '3 milliliter per kilogram per hour (mL/kg/hr) for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post procedure'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Technical problems with measurement leading to unreliable or uninterpretable data.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Technical problems with measurement leading to unreliable or uninterpretable data.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.', 'unitOfMeasure': 'milligrams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1, N-Acetylcysteine', 'description': 'Oral N-Acetylcysteine - 600 milligram (mg)'}, {'id': 'FG001', 'title': '2, Sodium Bicarbonate', 'description': 'Sodium bicarbonate, 3 milliliters per kilogram per hour (3 mL/kg/hr) for one hour pre-procedure and infused at 1 mL/kg/hr for 6 hrs post-procedure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1, N-Acetylcysteine', 'description': 'Oral N-acetylcysteine - 600 mg'}, {'id': 'BG001', 'title': '2, Sodium Bicarbonate', 'description': 'Sodium bicarbonate 3 mL/kg/hr for one hour pre-procedure and infused at 1 mL/kg/hr for 6 hours post-procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '60', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '61', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'whyStopped': 'Technical measurement problems led to unreliable or uninterpretable data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2010-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-26', 'studyFirstSubmitDate': '2007-12-18', 'resultsFirstSubmitDate': '2012-06-20', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-26', 'studyFirstPostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy', 'timeFrame': '2 years', 'description': 'Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contrast induced nephropathy'], 'conditions': ['Nephropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of Contrast-Induced Nephropathy (CIN) after cardiac catheterization.', 'detailedDescription': 'It is thought that N-acetylcysteine may reduce the ability of generated oxygen free radicals to damage cells by scavenging them. N-acetylcysteine may also increase the biologic effects of nitric oxide by combining with nitric oxide to form S-nitrosothiol, a more stable form and potent vasodilator. It also increases the expression of nitric oxide synthesis and may improve blood flow. Oxidants activate a signal-transduction cascade and molecular response that may initiate the cell-death pathway. These pathways seem to be sensitive to the redox state of the cell and are inhibited by N-acetylcysteine, which promotes pathways that lead to repair and survival whenever cells are under oxidant stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: 19 years of age\n\n* Baseline serum creatinine or\n* Calculated creatinine\n* Stable Renal Function\n* Left Ventricular ejection fraction\n* Non-pregnant, non-lactating females (all women of childbearing potential must have a negative serum pregnancy test. No contraception will be required\n* Able to sign informed consent\n\nExclusion Criteria:\n\n* Acute renal failure\n* History of Kidney transplant\n* Currently receiving N-acetylcysteine\n\n \\_ Contraindication of hypersensitivity to N-acetylcysteine or sodium bicarbonate\n* Left ventricular ejection fraction\n* Pregnant, lactating females\n* Allergy to contrast dye'}, 'identificationModule': {'nctId': 'NCT00579995', 'acronym': 'PROTECt', 'briefTitle': 'A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'A Prospective, Randomized Trial Comparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Cardiac Catheterization', 'orgStudyIdInfo': {'id': '0120-05-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'N-Acetylcysteine', 'description': 'Oral N-Acetylcysteine 600 mg', 'interventionNames': ['Drug: Oral N-Acetylcysteine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium Bicarbonate', 'description': 'Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure', 'interventionNames': ['Drug: Sodium Bicarbonate']}], 'interventions': [{'name': 'Oral N-Acetylcysteine', 'type': 'DRUG', 'otherNames': ['N-Acetyl-L-Cysteine'], 'description': '600 milligrams (mg)', 'armGroupLabels': ['N-Acetylcysteine']}, {'name': 'Sodium Bicarbonate', 'type': 'DRUG', 'otherNames': ['Sodium hydrogen carbonate', 'sodium acid carbonate', 'baking soda'], 'description': '3 milliliters per kilogram per hour (mL/kg/hr) for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure', 'armGroupLabels': ['Sodium Bicarbonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Unversity of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Scott Shurmur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}