Clinical trial NCT00175227: Prevention of Contrast-Induced Nephropathy
Official title: Prevention of Contrast-Induced Nephropathy: a Randomized Controlled Trial of Saline + Furosemide + Mannitol in High Risk Patients Undergoing Cardiac Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast-induced Nephropathy
Acute Renal Failure
Chronic Renal Failure
Keywords: contrast-induced nephropathy
prevention
renal failure
cardiac angiogram
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Heritage Foundation for Medical Research
First posted: 2005-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
timeFrame: Within 48 hours of angiogram
Secondary outcomes:
measure: Safety of the intervention based on transfer to ICU, need for dialysis, or death
timeFrame: During hospitalization episode
measure: Adverse clinical events and measures of renal function
timeFrame: 6 weeks post-angiogram
measure: Health related quality of life
timeFrame: 6 weeks post-angiogram
measure: Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine
timeFrame: Within 48 hours of angiogram
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospitals
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sumit R Majumdar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.