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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:
ClinicalTrials.gov Identifier:
NCT00494637
First Posted: July 2, 2007
Last Update Posted: January 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GE Healthcare
Information provided by:
Lenox Hill Hospital
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Lenox Hill Hospital:

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494637


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

Responsible Party: Jordan L. Rosenstock, MD, Lenox Hill Hospital
ClinicalTrials.gov Identifier: NCT00494637     History of Changes
Other Study ID Numbers: L06.10.058
First Submitted: June 29, 2007
First Posted: July 2, 2007
Last Update Posted: January 28, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases


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