Prevention of Contrast-Induced Nephropathy

Chronic Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175227
• Other study ID #: HSRIF #96-20
• Status: Completed
• Phase: N/A
• First received: September 10, 2005
• Last updated: May 9, 2011
• Start date: May 1996

Study information

• Verified date: May 2011
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: October 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Chronic Renal Failure
• Contrast-induced Nephropathy
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• intravenous saline hydration + mannitol + furosemide
500 mls half-normal saline + 25g mannitol + 100 mg furosemide
• intravenous saline hydration
500 mls half-normal saline

Locations

Country	Name	City	State
Canada	University of Alberta Hospitals	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Heritage Foundation for Medical Research

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients that develop contrast-induced nephropathy after cardiac angiography		Within 48 hours of angiogram	No
Secondary	Safety of the intervention based on transfer to ICU, need for dialysis, or death		During hospitalization episode	Yes
Secondary	Adverse clinical events and measures of renal function		6 weeks post-angiogram	Yes
Secondary	Health related quality of life		6 weeks post-angiogram	No
Secondary	Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine		Within 48 hours of angiogram	No