Prevention of Contrast-Induced Nephropathy

Condition(s) targeted: Contrast-Induced Nephropathy; Acute Renal Failure; Chronic Renal Failure

Intervention: intravenous saline + furosemide + mannitol (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Alberta

Official(s) and/or principal investigator(s):
Sumit R Majumdar, MD, MPH, Principal Investigator, Affiliation: University of Alberta

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.

Official title: Prevention of Contrast-Induced Nephropathy: a Randomized Controlled Trial of Saline + Furosemide + Mannitol in High Risk Patients Undergoing Cardiac Angiography

Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Proportion of patients that develop contrast-induced nephropathy within 48 hours of cardiac angiography

Secondary outcome:

Safety of the intervention

Clinical events in the six weeks post-angiogram

Health related quality of life six weeks post-angiogram

Subgroup analyses based on (a) diabetes; (b) nonionic contrast; (d) amount of contrast received; and (d) baseline creatinine

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 as a 25% relative increase in serum creatinine OR a 44 umol absolute increase in serum creatinine, whichever is smaller, within 48 hours of contrast exposure.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age > 21 years

- serum creatinine > 150 umol/L OR GFR < 60 ml/min documented within the previous year

- 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

University of Alberta Hospitals, Edmonton, Alberta T6G 2B7, Canada

Last updated: September 13, 2006