Prevention of Contrast-Induced Nephropathy: a Randomized Controlled Trial of Saline + Furosemide + Mannitol in High Risk Patients Undergoing Cardiac Angiography
Overview
- Phase
- N/A
- Intervention
- intravenous saline hydration + mannitol + furosemide
- Conditions
- Contrast-induced Nephropathy
- Sponsor
- University of Alberta
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Intervention
Saline hydration + mannitol + furosemide
Intervention: intravenous saline hydration + mannitol + furosemide
Controls
Saline hydration without mannitol or furosemide
Intervention: intravenous saline hydration
Outcomes
Primary Outcomes
Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
Time Frame: Within 48 hours of angiogram
Secondary Outcomes
- 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)