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

• ClinicalTrials.gov Identifier: NCT00556387
• Recruitment Status: Withdrawn
• First Posted: November 12, 2007
• Last Update Posted: November 1, 2013
• Sponsor: University of Arkansas
• Information provided by: University of Arkansas

Tracking Information

• First Submitted Date: November 9, 2007
• First Posted Date: November 12, 2007
• Last Update Posted Date: November 1, 2013
• Study Start Date: December 2008
• Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell Protection
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Traumatic Brain Injury

Intervention

• 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

• Placebo Comparator: 1
  Placebo Group receiving Saline Infusion.
  Intervention: Drug: saline
• Experimental: 2
  Case Group receiving Ketamine infusion.
  Intervention: Drug: Ketamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn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

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 1 Month to 16 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00556387
• Other Study ID Numbers: IRB 86674; 86674
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Carole Hamon, Regulatory Affairs Manager, University of Arkansas for Medical Sciences
• Study Sponsor: University of Arkansas
• Collaborators: Not Provided

Investigators

• Principal Investigator: Muayyad Tailounie, MD; Arkansas Children's Hospital Research Institute

• PRS Account: University of Arkansas
• Verification Date: October 2013