Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-29 @ 1:25 AM
Study NCT ID:
NCT00399256
Status:
TERMINATED
Last Update Posted:
2007-02-01
First Post:
2006-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}, {'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': 'D015032', 'term': 'Zinc'}], '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': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2007-01-31', 'studyFirstSubmitDate': '2006-11-13', 'studyFirstSubmitQcDate': '2006-11-13', 'lastUpdatePostDateStruct': {'date': '2007-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute renal failure'}], 'secondaryOutcomes': [{'measure': 'Rise in creatinine of > 0.5 mg/dl'}, {'measure': 'Rise in creatinine > 25%'}, {'measure': 'Significant rise in serum cystatin C)'}]}, 'conditionsModule': {'keywords': ['contrast-induced nephropathy', 'Acetylcysteine', 'Zinc', 'Cystatin C', 'Creatinine'], 'conditions': ['Chronic Kidney Failure']}, 'referencesModule': {'references': [{'pmid': '28302075', 'type': 'DERIVED', 'citation': 'Schanz M, Schaaf L, Dippon J, Biegger D, Fritz P, Alscher MD, Kimmel M. Renal effects of metallothionein induction by zinc in vitro and in vivo. BMC Nephrol. 2017 Mar 16;18(1):91. doi: 10.1186/s12882-017-0503-z.'}]}, 'descriptionModule': {'briefSummary': 'Background Prevention of contrast media (CM) induced nephropathy (CIN) by pharmacological prophylaxis (e.g. N-acetylcysteine; NAC) is controversially discussed. So far, in all interventional studies assessment of kidney function was based on measurements of serum creatinine although this surrogate biomarker has several limitations. We investigated the antioxidants NAC and zinc (Zn) for the prevention of CIN by monitoring concomitantly serum levels of creatinine and cystatin C.', 'detailedDescription': 'In a prospective, placebo-controlled, double blind trial patients with moderate impaired kidney function receiving hypoosmolar, nonionic contrast medium were randomly assigned to an oral treatment for 2 days with 1.2g/day of NAC (n=19), for 1 day with 60mg/day of Zn (n=18) or placebo (n=17). All patients were periprocedural hydrated with 1ml/kg/h of 0.45% saline for 24h. At baseline (before hydration), prior to exposure of CM as well as 2 and 6 days after CM serum levels of creatinine and cystatin C have been measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. older than 18 years of age,\n2. serum creatinine \\> 1.2 mg/dl or a creatinine clearance \\< 50 ml/min (measured by a 12 or 24 hour urine collection).\n\nExclusion Criteria:\n\n1. acute inflammatory disease,\n2. medication with NSAID or metformin until 3 days before entering study,\n3. abnormal findings in physical examinations, e.g. signs of dehydration or decompensated heart failure.'}, 'identificationModule': {'nctId': 'NCT00399256', 'briefTitle': 'Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn', 'organization': {'class': 'OTHER', 'fullName': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)'}, 'officialTitle': 'Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc', 'orgStudyIdInfo': {'id': 'IKP201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Acetylcysteine', 'type': 'DRUG'}, {'name': 'Zinc', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert-Bosch-Hospital', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Dominik M Alscher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert-Bosch-Hospital, Stuttgart, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)', 'class': 'OTHER'}}}}