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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
Est. primary completion date
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


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
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