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

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ClinicalTrials.gov Identifier: NCT00494637
Recruitment Status : Terminated (Not reaching recruitment and endpoint goals)
First Posted : July 2, 2007
Last Update Posted : January 28, 2009
Sponsor:
Collaborator:
GE Healthcare
Information provided by:
Lenox Hill Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Contrast Induced Nephropathy Drug: sodium bicarbonate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : July 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources


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


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


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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

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

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases