Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Ventricular Septal Defect Clinical Trial

Official title:

Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556361
• Other study ID #: 28781 Bhutta
• Secondary ID: CUMG
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2007
• Last updated: November 9, 2007
• Start date: July 2004
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Ventricular Septal Defect

Intervention

Drug:
• saline
2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass
• ketamine
2 mg/Kg IV within 5 minutes of cardiopulmonary bypass

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare expression of serum markers of CNS injury		within 48 hours
Primary	to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.		within 48 hours
Secondary	to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls		one month