Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT00540904
Status:
COMPLETED
Last Update Posted:
2014-03-03
First Post:
2007-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D017693', 'term': 'Sodium Bicarbonate'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-27', 'studyFirstSubmitDate': '2007-10-05', 'studyFirstSubmitQcDate': '2007-10-05', 'lastUpdatePostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast or dialysis needed', 'timeFrame': '2 days'}], 'secondaryOutcomes': [{'measure': 'change in serum bicarbonate change in serum potassium change in serum glucose change in serum creatinine change in estimated glomerular filtration rate incidence of contrast induced nephropathy comparison of cholesterol level', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['contrast', 'nephropathy', 'bicarbonate', 'prevention'], 'conditions': ['Radiographic Contrast Agent Nephropathy']}, 'referencesModule': {'references': [{'pmid': '15150204', 'type': 'RESULT', 'citation': 'Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.'}]}, 'descriptionModule': {'briefSummary': 'Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. The investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, \\>18 years old, with a GFR \\<60 and \\>30 ml/min/1,73m2 by MDRD formula and/or diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during and 6 hours before the injection. The primary end point will be the rise of 25% or more in creatinine or dialysis needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years old\n* cancer diagnosis\n* GFR \\< 60 and \\> 30 ml/min/1,73m2 by MDRD formula or diabetic\n* CT with contrast\n\nExclusion Criteria:\n\n* dialysis needed\n* uncontrolled hypertension\n* changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure\n* recent exposure to radiographic contrast agents (within previous two days of the study)\n* administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study'}, 'identificationModule': {'nctId': 'NCT00540904', 'briefTitle': 'Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate', 'organization': {'class': 'OTHER', 'fullName': 'Barretos Cancer Hospital'}, 'officialTitle': 'Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate', 'orgStudyIdInfo': {'id': '1-Silva'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sodium bicarbonate', 'description': 'Solution 154 mEq/L of sodium bicarbonate', 'interventionNames': ['Drug: sodium bicarbonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium chloride', 'description': 'Solution of 154 mEq/L of NaCl', 'interventionNames': ['Drug: NaCl']}], 'interventions': [{'name': 'sodium bicarbonate', 'type': 'DRUG', 'description': 'IV 154 mEq/L sodium bicarbonate. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.', 'armGroupLabels': ['sodium bicarbonate']}, {'name': 'NaCl', 'type': 'DRUG', 'description': 'IV 154 mEq/L solution of NaCl 0.9%. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.', 'armGroupLabels': ['Sodium chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14784-400', 'city': 'Barretos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital do Cancer de Barretos - Fundação PIO XII', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}], 'overallOfficials': [{'name': 'Ricardo G Silva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital do Cancer de Barretos - Fundação PIO XII'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barretos Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}