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Prevention of Contrast-Induced Nephropathy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00175227
Enrollment
200
Registered
2005-09-15
Start date
1996-05-31
Completion date
Unknown
Last updated
2011-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Chronic Renal Failure, Contrast-induced Nephropathy

Keywords

contrast-induced nephropathy, prevention, renal failure, cardiac angiogram

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.

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.

Interventions

DRUGintravenous saline hydration + mannitol + furosemide

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

DRUGintravenous saline hydration

500 mls half-normal saline

Sponsors

Alberta Heritage Foundation for Medical Research
CollaboratorOTHER
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Proportion of patients that develop contrast-induced nephropathy after cardiac angiographyWithin 48 hours of angiogram

Secondary

MeasureTime frame
Safety of the intervention based on transfer to ICU, need for dialysis, or deathDuring hospitalization episode
Adverse clinical events and measures of renal function6 weeks post-angiogram
Health related quality of life6 weeks post-angiogram
Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinineWithin 48 hours of angiogram

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026