Prevention of Contrast-Induced Nephropathy

May 9, 2011 updated by: University of Alberta

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University Of Alberta Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Alberta Heritage Foundation for Medical Research

Investigators

  • Principal Investigator: Sumit R Majumdar, MD, MPH, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1996

Primary Completion (Actual)

October 1, 2000

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 10, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSRIF #96-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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