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Use of Ketamine Prior to Cardiopulmonary Bypass in Children

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ClinicalTrials.gov Identifier: NCT00556361
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : November 12, 2007
Information provided by:
Arkansas Children's Hospital Research Institute

November 9, 2007
November 12, 2007
November 12, 2007
July 2004
Not Provided
  • 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 ]
Same as current
No Changes Posted
to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls [ Time Frame: one month ]
Same as current
Not Provided
Not Provided
Use of Ketamine Prior to Cardiopulmonary Bypass in Children
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Ventricular Septal Defect
  • Drug: saline
    2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass
  • Drug: ketamine
    2 mg/Kg IV within 5 minutes of cardiopulmonary bypass
  • Placebo Comparator: 1
    Intervention: Drug: saline
  • Experimental: 2
    Intervention: Drug: ketamine
Bhutta AT, Schmitz ML, Swearingen C, James LP, Wardbegnoche WL, Lindquist DM, Glasier CM, Tuzcu V, Prodhan P, Dyamenahalli U, Imamura M, Jaquiss RD, Anand KJ. Ketamine as a neuroprotective and anti-inflammatory agent in children undergoing surgery on cardiopulmonary bypass: a pilot randomized, double-blind, placebo-controlled trial. Pediatr Crit Care Med. 2012 May;13(3):328-37. doi: 10.1097/PCC.0b013e31822f18f9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2007
Not Provided

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
Sexes Eligible for Study: All
up to 1 Year   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
28781 Bhutta
Not Provided
Not Provided
Not Provided
Not Provided
Arkansas Children's Hospital Research Institute
Not Provided
Principal Investigator: Adnan T Bhutta, MD Arkansas Children's Hospital Research Institute
Arkansas Children's Hospital Research Institute
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP