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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
Sponsor:
Information provided by:
Arkansas Children's Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE November 9, 2007
First Posted Date  ICMJE November 12, 2007
Last Update Posted Date November 12, 2007
Study Start Date  ICMJE July 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2007)
to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls [ Time Frame: one month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Ketamine Prior to Cardiopulmonary Bypass in Children
Official Title  ICMJE Use of Ketamine Prior to Cardiopulmonary Bypass in Children
Brief Summary To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Ventricular Septal Defect
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: saline
  • Experimental: 2
    Intervention: Drug: ketamine
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2007)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00556361
Other Study ID Numbers  ICMJE 28781 Bhutta
CUMG
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Arkansas Children's Hospital Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adnan T Bhutta, MD Arkansas Children's Hospital Research Institute
PRS Account Arkansas Children's Hospital Research Institute
Verification Date November 2007

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