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
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.
|Condition or disease||Intervention/treatment||Phase|
|Head Trauma||Drug: Ketamine Drug: Sufentanil||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Ketamine Versus Sufentanil on Cerebral Glutamate After Traumatic Brain Injury : a Randomized, Double-blinded, Microdialysis Study|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||May 2017|
ketamine 5 mg/kg/h, continuous infusion for 48 hours
Active Comparator: sufentanil
sufentanil 0,5 mcg/kg/h, continuous infusion for 48 hours
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232347
|Contact: Ambroise MONTCRIOL, MD||0483162358 ext firstname.lastname@example.org|
|Sainte Anne Military Teaching Hospital|
|Toulon, France, 83130|
|Sub-Investigator: Pierre Julien CUNGI, MD|
|Sub-Investigator: Eric MEAUDRE, MD|
|Sub-Investigator: Henry BORET, MD|
|Principal Investigator:||Ambroise MONTCRIOL, MD||Direction Centrale du Service de Santé des Armées|