Prevention of Contrast-Induced Nephropathy

Not Applicable

Completed

• Conditions: Contrast-induced Nephropathy; Acute Renal Failure; Chronic Renal Failure
• Interventions: Drug: intravenous saline hydration + mannitol + furosemide; Drug: intravenous saline hydration

• Registration Number: NCT00175227
• Lead Sponsor: University of Alberta

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.

Study Timeline

• Study Start: 1996-05
• Primary Completion: 2000-10
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-15
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-09
• Last Update Posted: 2011-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	intravenous saline hydration + mannitol + furosemide	Saline hydration + mannitol + furosemide
Controls	intravenous saline hydration	Saline hydration without mannitol or furosemide

Primary Outcome Measures

Name	Time	Method
Proportion of patients that develop contrast-induced nephropathy after cardiac angiography	Within 48 hours of angiogram

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Alberta Hospitals; 🇨🇦 Edmonton, Alberta, Canada