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

This study has been terminated.
(Not reaching recruitment and endpoint goals)
Sponsor:
Collaborator:
GE Healthcare
Information provided by:
Lenox Hill Hospital
ClinicalTrials.gov Identifier:
NCT00494637
First received: June 29, 2007
Last updated: January 27, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention
Contrast Induced Nephropathy
 Drug: sodium bicarbonate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lenox Hill Hospital:

Primary Outcome Measures:
  • Incidence of contrast induced nephropathy [ Time Frame: 48-72 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 468
Study Start Date: July 2007
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sodium bicarbonate
    isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours
  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

Sponsors and Collaborators
Lenox Hill Hospital
GE Healthcare
Investigators
Principal Investigator: Jordan L Rosenstock, MD Lenox Hill Hospital
  More Information

No publications provided

Responsible Party: Jordan L. Rosenstock, MD, Lenox Hill Hospital
ClinicalTrials.gov Identifier: NCT00494637     History of Changes
Other Study ID Numbers: L06.10.058
Study First Received: June 29, 2007
Last Updated: January 27, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013