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

Primary Purpose

Contrast Induced Nephropathy

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sodium bicarbonate
Sponsored by
Lenox Hill Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • serum creatinine greater then or equal to 1.5

Exclusion Criteria:

  • EF<30
  • Overt CHF
  • Alkalemia
  • Hypokalemia
  • GFR<20 cc/min

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Incidence of contrast induced nephropathy

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2007
    Last Updated
    January 27, 2009
    Sponsor
    Lenox Hill Hospital
    Collaborators
    GE Healthcare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00494637
    Brief Title
    The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Terminated
    Why Stopped
    Not reaching recruitment and endpoint goals
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Lenox Hill Hospital
    Collaborators
    GE Healthcare

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Contrast Induced Nephropathy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    468 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    sodium bicarbonate
    Intervention Description
    isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours
    Primary Outcome Measure Information:
    Title
    Incidence of contrast induced nephropathy
    Time Frame
    48-72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: serum creatinine greater then or equal to 1.5 Exclusion Criteria: EF<30 Overt CHF Alkalemia Hypokalemia GFR<20 cc/min
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jordan L Rosenstock, MD
    Organizational Affiliation
    Lenox Hill Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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