Prevention of Contrast-Induced Nephropathy

Sponsor

University of Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT00175227

Collaborator

Alberta Heritage Foundation for Medical Research (Other)

200

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast-induced Nephropathy Acute Renal Failure Chronic Renal Failure	Drug: intravenous saline hydration + mannitol + furosemide Drug: intravenous saline hydration	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 1996

Actual Primary Completion Date :

Oct 1, 2000

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention

Saline hydration + mannitol + furosemide

Drug: intravenous saline hydration + mannitol + furosemide

500 mls half-normal saline + 25g mannitol + 100 mg furosemide

Placebo Comparator: Controls

Saline hydration without mannitol or furosemide

Drug: intravenous saline hydration

500 mls half-normal saline

Outcome Measures

Primary Outcome Measures

Proportion of patients that develop contrast-induced nephropathy after cardiac angiography [Within 48 hours of angiogram]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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