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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00175227 |
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Date of registration:
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10/09/2005 |
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Primary sponsor: |
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Public title:
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Prevention of Contrast-Induced Nephropathy
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Scientific title:
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Prevention of Contrast-Induced Nephropathy: a Randomized Controlled Trial of Saline + Furosemide + Mannitol in High Risk Patients Undergoing Cardiac Angiography |
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Date of first enrolment:
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May 1996 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00175227 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Canada
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Contacts
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Name:
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Sumit R Majumdar, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age > 21 years
- serum creatinine > 150 umol/L
- able and willing to provide informed consent
Exclusion Criteria:
- known hypersensitivity to contrast, furosemide, or mannitol
- unable to tolerate a fluid load (e.g., acute pulmonary edema)
- ESRD, on dialysis
- previous enrollment in this study or previous contrast administration with the last 2
weeks
- refusal by treating physician
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Renal Failure
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Chronic Renal Failure
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Contrast-induced Nephropathy
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Intervention(s)
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Drug: intravenous saline hydration
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Drug: intravenous saline hydration + mannitol + furosemide
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Primary Outcome(s)
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Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
[Time Frame: Within 48 hours of angiogram]
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Secondary Outcome(s)
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Adverse clinical events and measures of renal function
[Time Frame: 6 weeks post-angiogram]
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Health related quality of life
[Time Frame: 6 weeks post-angiogram]
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Safety of the intervention based on transfer to ICU, need for dialysis, or death
[Time Frame: During hospitalization episode]
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Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine
[Time Frame: Within 48 hours of angiogram]
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Secondary ID(s)
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HSRIF #96-20
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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