Prevention of Contrast-Induced Nephropathy

NCT ID: NCT00175227

Last Updated: 2011-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-05-31

Brief Summary

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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

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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.

Conditions

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Contrast-induced Nephropathy Acute Renal Failure Chronic Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Saline hydration + mannitol + furosemide

Group Type EXPERIMENTAL

intravenous saline hydration + mannitol + furosemide

Intervention Type DRUG

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

Controls

Saline hydration without mannitol or furosemide

Group Type PLACEBO_COMPARATOR

intravenous saline hydration

Intervention Type DRUG

500 mls half-normal saline

Interventions

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intravenous saline hydration + mannitol + furosemide

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

Intervention Type DRUG

intravenous saline hydration

500 mls half-normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Heritage Foundation for Medical Research

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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University of Alberta

Principal Investigators

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Sumit R Majumdar, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta Hospitals

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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. doi: 10.1053/j.ajkd.2009.03.024. Epub 2009 Jun 17.

Reference Type RESULT
PMID: 19535188 (View on PubMed)

Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.

Reference Type DERIVED
PMID: 39878152 (View on PubMed)

Other Identifiers

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HSRIF #96-20

Identifier Type: -

Identifier Source: org_study_id

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