Prevention of Contrast-Induced Nephropathy
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedMay 10, 2011
May 1, 2011
4.4 years
September 10, 2005
May 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
Within 48 hours of angiogram
Secondary Outcomes (4)
Safety of the intervention based on transfer to ICU, need for dialysis, or death
During hospitalization episode
Adverse clinical events and measures of renal function
6 weeks post-angiogram
Health related quality of life
6 weeks post-angiogram
Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine
Within 48 hours of angiogram
Study Arms (2)
Intervention
EXPERIMENTALSaline hydration + mannitol + furosemide
Controls
PLACEBO COMPARATORSaline hydration without mannitol or furosemide
Interventions
500 mls half-normal saline + 25g mannitol + 100 mg furosemide
Eligibility Criteria
You may qualify if:
- age \> 21 years
- serum creatinine \> 150 umol/L
- able and willing to provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta Hospitals
Edmonton, Alberta, T6G 2B7, Canada
Related Publications (2)
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.
PMID: 19535188RESULTHashimoto 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.
PMID: 39878152DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sumit R Majumdar, MD, MPH
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 15, 2005
Study Start
May 1, 1996
Primary Completion
October 1, 2000
Last Updated
May 10, 2011
Record last verified: 2011-05