Prevention of Contrast-Induced Nephropathy - Full Text View

Sponsor:	University of Alberta
Collaborator:	Health Services Research and Innovation Fund (Alberta Heritage Foundation for Medical Research)
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00175227

Purpose

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	Intervention
Contrast-induced Nephropathy Acute Renal Failure Chronic Renal Failure	Drug: intravenous saline hydration + mannitol + furosemide Drug: intravenous saline hydration

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Furosemide Mannitol

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:

Proportion of patients that develop contrast-induced nephropathy after cardiac angiography [ Time Frame: Within 48 hours of angiogram ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of the intervention based on transfer to ICU, need for dialysis, or death [ Time Frame: During hospitalization episode ] [ Designated as safety issue: Yes ]
Adverse clinical events and measures of renal function [ Time Frame: 6 weeks post-angiogram ] [ Designated as safety issue: Yes ]
Health related quality of life [ Time Frame: 6 weeks post-angiogram ] [ Designated as safety issue: No ]
Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine [ Time Frame: Within 48 hours of angiogram ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	May 1996
Primary Completion Date:	October 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175227

Locations

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

Sponsors and Collaborators

University of Alberta

Health Services Research and Innovation Fund (Alberta Heritage Foundation for Medical Research)

Investigators

Principal Investigator:

Sumit R Majumdar, MD, MPH

University of Alberta

More Information

Publications:

Majumdar SR, Kjellstrand CM, Tymchak WJ, Hervas-Malo M, Taylor DA, Teo KK. Forced euvolemic diuresis with mannitol and furosemide for prevention of contrast-induced nephropathy in patients with CKD undergoing coronary angiography: a randomized controlled trial. Am J Kidney Dis. 2009 Oct;54(4):602-9. Epub 2009 Jun 17.

Responsible Party:	Sumit Majumdar/Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier:	NCT00175227 History of Changes
Other Study ID Numbers:	HSRIF #96-20
Study First Received:	September 10, 2005
Last Updated:	May 9, 2011
Health Authority:	Canada: Health Canada

Keywords provided by University of Alberta:

contrast-induced nephropathy
prevention
renal failure
cardiac angiogram

Additional relevant MeSH terms:

Kidney Diseases
Acute Kidney Injury
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Furosemide
Mannitol
Sodium Potassium Chloride Symporter Inhibitors

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses
Diuretics, Osmotic

ClinicalTrials.gov processed this record on February 09, 2012