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

This study is not yet open for participant recruitment.
Verified by Lenox Hill Hospital, June 2007

Sponsors and Collaborators: Lenox Hill Hospital
GE Healthcare
Information provided by: Lenox Hill Hospital
ClinicalTrials.gov Identifier: NCT00494637
  Purpose

Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. We 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 Intervention
Contrast Induced Nephropathy
Drug: sodium bicarbonate

Drug Information available for:   Sodium bicarbonate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Lenox Hill Hospital:

Primary Outcome Measures:
  • Incidence of contrast induced nephropathy [ Time Frame: 48-72 hours ]

Study Start Date:   July 2007

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494637

Contacts
Contact: Jordan L Rosenstock, MD     212-988-8149     jrosenstock@lenoxhill.net    

Locations
United States, New York
Lenox Hill Hospital    
      New York, New York, United States, 10021

Sponsors and Collaborators
Lenox Hill Hospital
GE Healthcare

Investigators
Principal Investigator:     Jordan L Rosenstock, MD     Lenox Hill Hospital    
  More Information


Study ID Numbers:   L06.10.058
First Received:   June 29, 2007
Last Updated:   June 29, 2007
ClinicalTrials.gov Identifier:   NCT00494637
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Urologic Diseases
Kidney Diseases

ClinicalTrials.gov processed this record on November 06, 2008




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