Skip to main content
Clinical Trials/NCT00494637
NCT00494637TerminatedNot Applicable

The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy

Lenox Hill Hospital0 sites468 target enrollmentStarted: July 1, 2007Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
468
Primary Endpoint
Incidence of contrast induced nephropathy

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • serum creatinine greater then or equal to 1.5

Exclusion Criteria

  • Overt CHF
  • Alkalemia
  • Hypokalemia
  • GFR<20 cc/min

Outcomes

Primary Outcomes

Incidence of contrast induced nephropathy

Time Frame: 48-72 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Lenox Hill Hospital
Sponsor Class
Other

Similar Trials