The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
Sponsor
Lenox Hill Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT00494637
Collaborator
GE Healthcare (Industry)
468
18.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
468 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Study Start Date
:
Jul 1, 2007
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Jan 1, 2009
Outcome Measures
Primary Outcome Measures
- Incidence of contrast induced nephropathy [48-72 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- serum creatinine greater then or equal to 1.5
Exclusion Criteria:
-
EF<30
-
Overt CHF
-
Alkalemia
-
Hypokalemia
-
GFR<20 cc/min
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lenox Hill Hospital
- GE Healthcare
Investigators
- Principal Investigator: Jordan L Rosenstock, MD, Lenox Hill Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00494637
Other Study ID Numbers:
- L06.10.058
First Posted:
Jul 2, 2007
Last Update Posted:
Jan 28, 2009
Last Verified:
Jan 1, 2009
Additional relevant MeSH terms: