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Clinical Trials/NCT00494637
NCT00494637
Terminated
Not Applicable

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

Lenox Hill Hospital0 sites468 target enrollmentJuly 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Contrast Induced Nephropathy
Sponsor
Lenox Hill Hospital
Enrollment
468
Primary Endpoint
Incidence of contrast induced nephropathy
Status
Terminated
Last Updated
17 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
January 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lenox Hill Hospital

Eligibility Criteria

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

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