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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
Study 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 January 16, 2009