Prevention of Contrast-Induced Nephropathy

Study Overview
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Brief Summary
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Patients with pre-existing kidney disease are at high risk of acute renal failure when exposed to radio-contrast dyes, for example during a cardiac angiogram. The investigators hypothesize that an infusion of saline + furosemide + mannitol will reduce rates of contrast-induced nephropathy when compared with saline infusion controls.

Detailed Description
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Patients with pre-existing kidney disease are at high risk of acute renal failure when exposed to radio-contrast dyes, for example during a cardiac angiogram. We hypothesize that an infusion of saline + furosemide + mannitol will reduce rates of contrast-induced nephropathy when compared with saline infusion controls. We define an episode of contrast nephropathy using the conventional often published definition of a 25% relative increase in serum creatinine OR a 44 umol absolute increase in serum creatinine within 48 hours of contrast exposure.

Official 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

Conditions
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Contrast-induced Nephropathy, Acute Renal Failure, Chronic Renal Failure

Intervention / Treatment
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* Drug: intravenous saline hydration + mannitol + furosemide
* Drug: intravenous saline hydration


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Saline hydration + mannitol + furosemide | Drug: intravenous saline hydration + mannitol + furosemide<br>* 500 mls half-normal saline + 25g mannitol + 100 mg furosemide<br>|
| Placebo Comparator: Controls<br>Saline hydration without mannitol or furosemide | Drug: intravenous saline hydration<br>* 500 mls half-normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that develop contrast-induced nephropathy after cardiac angiography |  | Within 48 hours of angiogram | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the intervention based on transfer to ICU, need for dialysis, or death |  | During hospitalization episode | 
| Adverse clinical events and measures of renal function |  | 6 weeks post-angiogram | 
| Health related quality of life |  | 6 weeks post-angiogram | 
| Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine |  | Within 48 hours of angiogram | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, contrast-induced nephropathy, renal failure, cardiac angiogram