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Use of Ketamine Prior to Cardiopulmonary Bypass in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556361
First Posted: November 12, 2007
Last Update Posted: November 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Interventional
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.
 
Completed
24
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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00556361
28781 Bhutta
CUMG
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