Use of Ketamine Prior to Cardiopulmonary Bypass in Children

November 9, 2007 updated by: Arkansas Children's Hospital Research Institute
To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: ketamine
2 mg/Kg IV within 5 minutes of cardiopulmonary bypass
Placebo Comparator: 1
Drug: saline
2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare expression of serum markers of CNS injury
Time Frame: within 48 hours
within 48 hours
to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.
Time Frame: within 48 hours
within 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Investigators

  • Principal Investigator: Adnan T Bhutta, MD, Arkansas Children's Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (Estimate)

November 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 12, 2007

Last Update Submitted That Met QC Criteria

November 9, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28781 Bhutta
  • CUMG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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