Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Ketamine

Brief Summary

To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.

Intervention / Treatment

  • Saline (DRUG)
    2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass
  • Ketamine (DRUG)
    2 mg/Kg IV within 5 minutes of cardiopulmonary bypass

Condition or Disease

  • Ventricular Septal Defect

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: up to 1 Year   (Child)
    Enrollment: 24 (ACTUAL)
    Funded by: Other
    Allocation: Non-Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jul 01, 2004
    Primary Completion: Aug 31, 2020
    Completion Date: Nov 01, 2007 ACTUAL
    Study First Posted: Nov 12, 2007 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 09, 2007

    Sponsors / Collaborators

    Lead Sponsor: Arkansas Children's Hospital Research Institute
    Responsible Party: N/A
    No responsible party listed

    Location

    Little Rock, Arkansas, USA

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Maximum Age: 1
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * less than one year of age
    * undergoing cardiac surgery for repair of ventricular septal defect
    * requiring cardiopulmonary bypass
    * not requiring retrogrades cerebral perfusion

    Exclusion Criteria:

    * Downs Syndrome

    Primary Outcomes
    • To compare expression of serum markers of CNS injury within 48 hours
    • to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls. within 48 hours
    Secondary Outcomes
    • to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls one month

    More Details

    NCT Number: NCT00556361
    Other IDs: 28781 Bhutta
    Study URL: https://clinicaltrials.gov/study/NCT00556361
    Last updated: Sep 29, 2023