The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
Primary Purpose
Contrast Induced Nephropathy
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sodium bicarbonate
Sponsored by
About this trial
This is an interventional prevention trial for Contrast Induced Nephropathy
Eligibility Criteria
Inclusion Criteria:
- serum creatinine greater then or equal to 1.5
Exclusion Criteria:
- EF<30
- Overt CHF
- Alkalemia
- Hypokalemia
- GFR<20 cc/min
Sites / Locations
Outcomes
Primary Outcome Measures
Incidence of contrast induced nephropathy
Secondary Outcome Measures
Full Information
NCT ID
NCT00494637
First Posted
June 29, 2007
Last Updated
January 27, 2009
Sponsor
Lenox Hill Hospital
Collaborators
GE Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT00494637
Brief Title
The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
Not reaching recruitment and endpoint goals
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lenox Hill Hospital
Collaborators
GE Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. The primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. Patients with an ejection fraction <30%, overt CHF, hypokalemia and alkalemia will be excluded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
468 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sodium bicarbonate
Intervention Description
isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours
Primary Outcome Measure Information:
Title
Incidence of contrast induced nephropathy
Time Frame
48-72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
serum creatinine greater then or equal to 1.5
Exclusion Criteria:
EF<30
Overt CHF
Alkalemia
Hypokalemia
GFR<20 cc/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan L Rosenstock, MD
Organizational Affiliation
Lenox Hill Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
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