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Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell Protection

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.
 
ClinicalTrials.gov Identifier: NCT00556387
Recruitment Status : Withdrawn (This study has been withdraw from the IRB. The PI has transferred to another university. The IND was transferred.)
First Posted : November 12, 2007
Last Update Posted : November 1, 2013
Sponsor:
Information provided by:
University of Arkansas

Tracking Information
First Submitted Date  ICMJE November 9, 2007
First Posted Date  ICMJE November 12, 2007
Last Update Posted Date November 1, 2013
Study Start Date  ICMJE December 2008
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2007)
To compare clinical, radiological, and neurodevelopmental outcomes between children who receive ketamine vs placebo infusions following traumatic brain injury. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2007)
To compare the expression of biomarkers of CNS injury between cases and controls. [ Time Frame: 96 hours ]
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 Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell Protection
Official Title  ICMJE Possible Neuroprotective Effects of Ketamine in Children With Severe Traumatic Brain Injury
Brief Summary

The purpose of this study is to determine the possible effects of an anesthetic agent called Ketamine on the injured brain in children.

The researchers think that it will effect the outcomes of children with these injuries.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Drug: saline
    1 mg/kg IV bolus slowly over 1-2 minutes followed by 0.5 mg/kg IV continuous infusion over 48 hours or until discontinuation of ICP monitor (whichever occurs first)
  • Drug: Ketamine
    1 mg/kg IV bolus slowly over 1-2 minutes, followed by 0.5 mg/kg IV continuous infusion for 48 hours or until discontinuation of ICP monitor (whichever occurs first)
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo Group receiving Saline Infusion.
    Intervention: Drug: saline
  • Experimental: 2
    Case Group receiving Ketamine infusion.
    Intervention: Drug: Ketamine
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 31, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2007)
100
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • are 1 month to 16 years of age; AND
  • are admitted to the PICU following severe TBI (any GCS 3-8 inclusive) within 8 hours after the injury; AND
  • are intubated and ventilated for the management of TBI; AND
  • are anticipated to have an indwelling arterial or venous catheter for blood sampling during the first three days of study enrollment; AND
  • have an intra-cranial pressure (ICP) monitoring device for management of TBI.

Exclusion Criteria:

  • are less than 4 kilograms in weight upon admission
  • are less than 1 month of age;
  • are greater than 16 years of age;
  • have a clinical diagnosis of non-accidental TBI;
  • have suffered immersion injury or prolonged hypoxic injury (lasting greater than 10 minutes);
  • have a known allergy to ketamine;
  • have a planned removal of endotracheal tube or the removal of central venous catheter AND arterial catheter within 72 hours of study enrollment;
  • have a current history of neuromuscular disease;
  • have a current history of hepatic failure;
  • have a current history of glaucoma
  • require chronic treatment with anti-epileptic drugs (AEDs) or devices;
  • more than 8 hours have elapsed from the time of injury to PICU admission;
  • have documentation of a positive pregnancy test at the time of enrollment;
  • if there is a lack of commitment to aggressive intensive care therapies (the subject is either on a DNR status due to pre-existing medical condition, or the family decides to withdraw support prior to participation in the study due to other multiple severe injuries and organ failures resulting from the trauma).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00556387
Other Study ID Numbers  ICMJE IRB 86674
86674
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carole Hamon, Regulatory Affairs Manager, University of Arkansas for Medical Sciences
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muayyad Tailounie, MD Arkansas Children's Hospital Research Institute
PRS Account University of Arkansas
Verification Date October 2013

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