Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Arkansas Children's Hospital Research Institute24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Ventricular Septal Defect

Interventions

salineDRUG

2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass

ketamineDRUG

2 mg/Kg IV within 5 minutes of cardiopulmonary bypass

Eligibility

Sex: ALLMax age: 1 Year

Medical Language ↔ Plain English

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

Locations (1)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

To compare expression of serum markers of CNS injury

Time frame: within 48 hours

to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.

Time frame: within 48 hours

Secondary Outcomes

to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls

Time frame: one month

Data from ClinicalTrials.gov

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