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OpenTrials
Completed

NCT Number: NCT00556361

Use of Ketamine Prior to Cardiopulmonary Bypass in Children

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

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Key information

Conditions

Ventricular Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Drug

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

ketamine

Drug

2 mg/Kg IV within 5 minutes of cardiopulmonary bypass

Primary outcomes

  1. To compare expression of serum markers of CNS injury

    Time frame: within 48 hours

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

    Time frame: within 48 hours

Secondary outcomes

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

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Nov 12, 2007
Registry last updated
Nov 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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