Back to resultsPrevention of Contrast-Induced Nephropathy
Primary Purpose
Contrast-induced Nephropathy, Acute Renal Failure, Chronic Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
intravenous saline hydration + mannitol + furosemide
intravenous saline hydration
Sponsored by
About this trial
This is an interventional prevention trial for Contrast-induced Nephropathy focused on measuring contrast-induced nephropathy, prevention, renal failure, cardiac angiogram
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
Sites / Locations
- University of Alberta Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Controls
Arm Description
Saline hydration + mannitol + furosemide
Saline hydration without mannitol or furosemide
Outcomes
Primary Outcome Measures
Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
Secondary Outcome Measures
Safety of the intervention based on transfer to ICU, need for dialysis, or death
Adverse clinical events and measures of renal function
Health related quality of life
Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine
Full Information
NCT ID
NCT00175227
First Posted
September 10, 2005
Last Updated
May 9, 2011
Sponsor
University of Alberta
Collaborators
Alberta Heritage Foundation for Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT00175227
Brief Title
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
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 1996 (undefined)
Primary Completion Date
October 2000 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Alberta
Collaborators
Alberta Heritage Foundation for Medical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-induced Nephropathy, Acute Renal Failure, Chronic Renal Failure
Keywords
contrast-induced nephropathy, prevention, renal failure, cardiac angiogram
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Saline hydration + mannitol + furosemide
Arm Title
Controls
Arm Type
Placebo Comparator
Arm Description
Saline hydration without mannitol or furosemide
Intervention Type
Drug
Intervention Name(s)
intravenous saline hydration + mannitol + furosemide
Intervention Description
500 mls half-normal saline + 25g mannitol + 100 mg furosemide
Intervention Type
Drug
Intervention Name(s)
intravenous saline hydration
Intervention Description
500 mls half-normal saline
Primary Outcome Measure Information:
Title
Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
Time Frame
Within 48 hours of angiogram
Secondary Outcome Measure Information:
Title
Safety of the intervention based on transfer to ICU, need for dialysis, or death
Time Frame
During hospitalization episode
Title
Adverse clinical events and measures of renal function
Time Frame
6 weeks post-angiogram
Title
Health related quality of life
Time Frame
6 weeks post-angiogram
Title
Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine
Time Frame
Within 48 hours of angiogram
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumit R Majumdar, MD, MPH
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospitals
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
19535188
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.
Results Reference
result
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Prevention of Contrast-Induced Nephropathy
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