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

NCT00494637 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2009-01-28

No results posted yet for this study

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.

Conditions

  • Contrast Induced Nephropathy

Interventions

DRUG

sodium bicarbonate

isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • Lenox Hill Hospital

    lead OTHER

Principal Investigators

  • Jordan L Rosenstock, MD · Lenox Hill Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-12-31
Completion
2009-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00494637 on ClinicalTrials.gov