Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Phase 2

Completed

• Conditions: Ventricular Septal Defect
• Interventions: Drug: saline; Drug: ketamine

• Registration Number: NCT00556361
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Status Verified: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Last Update Submitted: 2007-11-09
• Study First Posted: 2007-11-12
• Last Update Posted: 2007-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

• Downs Syndrome

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	saline	-
2	ketamine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls	one month

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States