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Completed

NCT Number: NCT00175227

Prevention of Contrast-Induced Nephropathy

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.

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Key information

Conditions

Contrast-induced Nephropathy Acute Kidney Injury Acute Renal Failure Chronic Disease Chronic Renal Failure Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospitals

Edmonton, Alberta, T6G 2B7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous saline hydration + mannitol + furosemide

Drug

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

intravenous saline hydration

Drug

500 mls half-normal saline

Primary outcomes

  1. Proportion of patients that develop contrast-induced nephropathy after cardiac angiography

    Time frame: Within 48 hours of angiogram

Secondary outcomes

  1. Safety of the intervention based on transfer to ICU, need for dialysis, or death

    Time frame: During hospitalization episode

  2. Adverse clinical events and measures of renal function

    Time frame: 6 weeks post-angiogram

  3. Health related quality of life

    Time frame: 6 weeks post-angiogram

  4. Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine

    Time frame: Within 48 hours of angiogram

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Heritage Foundation for Medical Research

Registry information

Official study title

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

Important dates

Study start
1996
Primary completion
2000
First posted
Sep 15, 2005
Registry last updated
May 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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