Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-29 @ 12:08 PM
Study NCT ID:
NCT00384995
Status:
TERMINATED
Last Update Posted:
2010-12-01
First Post:
2006-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bicarbonate v Saline to Prevent Contrast Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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'}, {'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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D017693', 'term': 'Sodium Bicarbonate'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-29', 'studyFirstSubmitDate': '2006-10-05', 'studyFirstSubmitQcDate': '2006-10-05', 'lastUpdatePostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of contrast-induced nephropathy, CIN, defined as an increase in serum creatinine of 25% or more from pre-intervention baseline to within 48-72 hours after administration of the radiographic contrast.', 'timeFrame': '48-72 hours'}], 'secondaryOutcomes': [{'measure': 'Group mean change in serum creatinine', 'timeFrame': '48-72 hours'}, {'measure': 'Days in hospital within the week post contrast', 'timeFrame': 'One week'}, {'measure': 'Requirement for dialysis', 'timeFrame': 'Two months'}, {'measure': 'Atheroembolic events', 'timeFrame': 'Two months'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': 'Two months'}, {'measure': 'Death', 'timeFrame': 'Two months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Contrast Induced Nephropathy', 'Chronic Kidney Disease', 'Acute Renal Failure', 'End-stage Renal Disease', 'Cardiovascular diseases', 'Coronary catheterization', 'Percutaneous coronary intervention', 'Intra-arterial angiography', 'Bicarbonate', 'Saline'], 'conditions': ['Kidney Failure, Acute', 'Contrast Media']}, 'referencesModule': {'references': [{'pmid': '15150204', 'type': 'BACKGROUND', '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.'}, {'pmid': '17943084', 'type': 'DERIVED', 'citation': 'Ravani P, Tripepi G, Pecchini P, Mallamaci F, Malberti F, Zoccali C. Urotensin II is an inverse predictor of death and fatal cardiovascular events in chronic kidney disease. Kidney Int. 2008 Jan;73(1):95-101. doi: 10.1038/sj.ki.5002565. Epub 2007 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.', 'detailedDescription': 'A decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. Deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy. However, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear.\n\nIt has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels. A recent trial found a lower frequency of creatinine rise \\> 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws.\n\nComparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1 ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2 ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Booked for cardiac or other non-renal arteriography\n* Pre-existing reduced kidney function: Serum Creatinine \\>= 1.3 \\& \\<= 4 mg/dl (female gender) or \\>= 1.5 \\& \\<= 5 mg/dl (male gender)\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* GFR MDRD estimate \\< 15 ml/min/m2\n* End-stage renal disease already on dialysis\n* Known current Acute Kidney Failure with serum creatinine rise of \\> 0.5 mg/dl within 24 hours\n* Pulmonary edema - current or within 48 hours\n* Clinically relevant ascites, edema or other fluid overload\n* Uncontrolled hypertension (\\> 165 mmHg systolic, or \\> 105 mmHg diastolic)\n* Hemodynamically unstable patient requiring IV nitroglycerine, or IV fluid or inotropes for blood pressure support\n* Emergency (unplanned) angiography\n* IV contrast procedure\n* Exposure to iodinated radiocontrast within 3 days prior to study\n* Prior anaphylactoid reaction to contrast\n* Planned administration of N-acetylcysteine\n* Planned administration of dopamine, fenoldopam or mannitol\n* Current pregnancy'}, 'identificationModule': {'nctId': 'NCT00384995', 'briefTitle': 'Bicarbonate v Saline to Prevent Contrast Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Italian Society of Nephrology'}, 'officialTitle': 'Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol)', 'orgStudyIdInfo': {'id': 'PR021676'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bicarbonate', 'description': 'Bicarbonate solution infusion', 'interventionNames': ['Drug: 1/6 M (166 mEq/L) IV Sodium Bicarbonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline', 'description': 'Standard volume expansion', 'interventionNames': ['Drug: 0.9% (154 mEq/L) IV Sodium Chloride']}], 'interventions': [{'name': '0.9% (154 mEq/L) IV Sodium Chloride', 'type': 'DRUG', 'otherNames': ['Sodium Chloride'], 'description': 'Saline solution', 'armGroupLabels': ['Saline']}, {'name': '1/6 M (166 mEq/L) IV Sodium Bicarbonate', 'type': 'DRUG', 'otherNames': ['Sodium Bicarbonate'], 'description': 'Bicarbonate solution', 'armGroupLabels': ['Bicarbonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '95100', 'city': 'Catania', 'country': 'Italy', 'facility': 'Ospedale Ferrarotto', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '20063', 'city': 'Cernusco sul Naviglio', 'country': 'Italy', 'facility': 'P.O. Uboldo', 'geoPoint': {'lat': 45.52526, 'lon': 9.33297}}, {'zip': '26100', 'city': 'Cremona', 'country': 'Italy', 'facility': 'Azienda Istituti Ospitalieri di Cremona', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'zip': '20097', 'city': 'San Donato', 'country': 'Italy', 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.08201, 'lon': 7.66485}}], 'overallOfficials': [{'name': 'Pietro Ravani, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Italian Society of Nephrology'}, {'name': 'Brendan BJ Barrett, MD, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial University of Newfoundland'}, {'name': 'Ferruccio Conte, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Italian Society of Nephrology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Italian Society of Nephrology', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}, {'name': 'Memorial University of Newfoundland', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Pietro Ravani', 'oldOrganization': 'Italian Society of Nephrology'}}}}