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Ketamine and Glutamate After Brain Injury : a Microdialysis Study (KETABRAIN)

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ClinicalTrials.gov Identifier: NCT02232347
Recruitment Status : Unknown
Verified September 2014 by Pierre-Julien CUNGI, Direction Centrale du Service de Santé des Armées.
Recruitment status was:  Not yet recruiting
First Posted : September 5, 2014
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
Pierre-Julien CUNGI, Direction Centrale du Service de Santé des Armées

Tracking Information
First Submitted Date  ICMJE September 2, 2014
First Posted Date  ICMJE September 5, 2014
Last Update Posted Date September 5, 2014
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
brain glutamate concentrations [ Time Frame: H0-H12, H12-H24, H24-H36 and H36-H48 ]
To compare the kinetic of brain glutamate concentration decrease during 4 periods of 12 hours between ketamine infusion group (KET) and sufentanil standard infusion group (STD)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
  • metabolic profile [ Time Frame: H0-H12, H12-H24, H24-H36 and H36-H48 ]
    To compare the brain metabolic profile (normal, ischemic, hyperglycolytic and metabolic crisis) of the patients related to their group of treatment : ketamine (KET) and sufentanil (STD) by measuring brain glucose, brain lactate, brain glycerol concentrations and brain lactate/pyruvate ratio.
  • Episodes of intracranial hypertension (ICHT) and brain ischemia [ Time Frame: H0-H12, H12-H24, H24-H36 and H36-H48 ]
    To compare the number of ICHT episodes (ICP>20 mm Hg more than 15 minutes) and to compare the number of ischemic episodes (PtiO2<20 mm Hg more than 15 minutes) between the 2 groups
  • Therapeutic Intensity Level (TIL) [ Time Frame: Days 1 and 2 ]
    To compare the TIL value between the 2 groups. TIL is a score developed to measure the intensity of cares for head trauma patients. Lower scores are meaning less intense cares. It is calculated for 24 hours periods.
  • Glasgow Outcome Scale (GOS) et extended Glasgow Outcome Scale (eGOS) [ Time Frame: 6 months and 1 year ]
    To describe the prognosis of the patients of the KETAMINE group versus SUFENTANIL group. GOS is the international validated score for evaluation of the prognosis after head trauma.
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 Ketamine and Glutamate After Brain Injury : a Microdialysis Study
Official Title  ICMJE Effect of Ketamine Versus Sufentanil on Cerebral Glutamate After Traumatic Brain Injury : a Randomized, Double-blinded, Microdialysis Study
Brief Summary

The objective of the study is to compare the effects of 48 hours ketamine infusion versus sufentanil infusion on brain glutamate concentrations measured with microdialysis after traumatic brain injury.

We hypothesize that ketamine infusion will decrease high glutamate values faster than sufentanil.

Detailed Description

Inclusion of 20 consecutive head trauma patients. Randomization and double-blind to compare the effects of ketamine versus sufentanil on brain glutamate concentrations measured with microdialysis.

Ketamine is an anti-N-methyl-D-aspartate (NMDA) medication. It is supposed to limit excitotoxicity of amino-acids, especially glutamate. Glutamate is known to be elevated in more than 60% of the severe head trauma patients. It induces cortical spreading depression which can aggravate prognosis. It's a daily used medication in anesthesia and intensive care units for sedation and induction of anesthesia. It's the recommended medication for induction of unstable wounded soldiers on the field because of its neutrality on haemodynamic state.

Sufentanil is the reference opioid for sedation in ICU in Europe. It can induce hypotension which is deleterious for cerebral perfusion pressure after brain trauma.

In our unit, patients with severe head injury are monitored by a triple lumen access device including ICP (IntraCerebral Pressure), PtiO2 (oxygen pressure in the brain) and microdialysis. This last monitoring allows measurement of brain parenchymal concentrations of small molecules : glucose, lactate, pyruvate, glutamate, glycerol,.... It's a tool to evaluate the metabolic state of the brain divided into 4 categories : normal, hyperglycolysis, ischemia and metabolic crisis.

Then, we will detail the effects of ketamine on metabolic state of the brain, especially glutamate concentration. Normal values are below 10 micromol/ml. After head trauma it can dramatically increase to values up to 50 or even 100 micromol/ml, with normalization after 24 hours. Ketamine is expected to decrease these high values faster than described in observational studies.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Head Trauma
Intervention  ICMJE
  • Drug: Ketamine
  • Drug: Sufentanil
Study Arms  ICMJE
  • Experimental: ketamine
    ketamine 5 mg/kg/h, continuous infusion for 48 hours
    Intervention: Drug: Ketamine
  • Active Comparator: sufentanil
    sufentanil 0,5 mcg/kg/h, continuous infusion for 48 hours
    Intervention: Drug: Sufentanil
Publications *

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 2, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2017
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • > 18 years old
  • Glasgow Coma Scale (GCS) < 9
  • > 3 days of sedation expected at the arrival

Exclusion Criteria:

  • pregnancy
  • < 18 years old
  • estimated survival < 48 hours post-trauma
  • expected sedation < 3 days
  • coagulation impairment (platelets<100.000/mm3 and prothrombin time (TP) <60%)
  • Cardiac arrest before ICU admission
  • Admission > 12 hours after trauma
  • Multimodal monitoring implanted > 24 hours post trauma
  • Participation to the study refused by the next of kind
  • No next of kind
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02232347
Other Study ID Numbers  ICMJE DCSSA KETABRAIN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pierre-Julien CUNGI, Direction Centrale du Service de Santé des Armées
Study Sponsor  ICMJE Pierre-Julien CUNGI
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ambroise MONTCRIOL, MD Direction Centrale du Service de Santé des Armées
PRS Account Direction Centrale du Service de Santé des Armées
Verification Date September 2014

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