Head Trauma Clinical Trial
— KETABRAINOfficial title:
Effect of Ketamine Versus Sufentanil on Cerebral Glutamate After Traumatic Brain Injury : a Randomized, Double-blinded, Microdialysis Study
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | May 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Sainte Anne Military Teaching Hospital | Toulon |
Lead Sponsor | Collaborator |
---|---|
Pierre-Julien CUNGI |
France,
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. — View Citation
Bourgoin A, Albanèse J, Léone M, Sampol-Manos E, Viviand X, Martin C. Effects of sufentanil or ketamine administered in target-controlled infusion on the cerebral hemodynamics of severely brain-injured patients. Crit Care Med. 2005 May;33(5):1109-13. — View Citation
Bourgoin A, Albanèse J, Wereszczynski N, Charbit M, Vialet R, Martin C. Safety of sedation with ketamine in severe head injury patients: comparison with sufentanil. Crit Care Med. 2003 Mar;31(3):711-7. — View Citation
Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS, Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. I. Blood pressure and oxygenation. J Neurotrauma. 2007;24 Suppl 1:S7-13. Erratum in: J Neurotrauma. 2008 Mar;25(3):276-8. multiple author names added. — View Citation
Chamoun R, Suki D, Gopinath SP, Goodman JC, Robertson C. Role of extracellular glutamate measured by cerebral microdialysis in severe traumatic brain injury. J Neurosurg. 2010 Sep;113(3):564-70. doi: 10.3171/2009.12.JNS09689. — View Citation
Filanovsky Y, Miller P, Kao J. Myth: Ketamine should not be used as an induction agent for intubation in patients with head injury. CJEM. 2010 Mar;12(2):154-7. Review. — View Citation
Hartings JA, Bullock MR, Okonkwo DO, Murray LS, Murray GD, Fabricius M, Maas AI, Woitzik J, Sakowitz O, Mathern B, Roozenbeek B, Lingsma H, Dreier JP, Puccio AM, Shutter LA, Pahl C, Strong AJ; Co-Operative Study on Brain Injury Depolarisations. Spreading depolarisations and outcome after traumatic brain injury: a prospective observational study. Lancet Neurol. 2011 Dec;10(12):1058-64. doi: 10.1016/S1474-4422(11)70243-5. Epub 2011 Nov 3. — View Citation
Hudetz JA, Pagel PS. Neuroprotection by ketamine: a review of the experimental and clinical evidence. J Cardiothorac Vasc Anesth. 2010 Feb;24(1):131-42. doi: 10.1053/j.jvca.2009.05.008. Epub 2009 Jul 29. Review. — View Citation
Hughes S. Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 3: is ketamine a viable induction agent for the trauma patient with potential brain injury. Emerg Med J. 2011 Dec;28(12):1076-7. doi: 10.1136/emermed-2011-200891. Review. — View Citation
Raboel PH, Bartek J Jr, Andresen M, Bellander BM, Romner B. Intracranial Pressure Monitoring: Invasive versus Non-Invasive Methods-A Review. Crit Care Res Pract. 2012;2012:950393. doi: 10.1155/2012/950393. Epub 2012 Jun 8. — View Citation
Sakowitz OW, Kiening KL, Krajewski KL, Sarrafzadeh AS, Fabricius M, Strong AJ, Unterberg AW, Dreier JP. Preliminary evidence that ketamine inhibits spreading depolarizations in acute human brain injury. Stroke. 2009 Aug;40(8):e519-22. doi: 10.1161/STROKEAHA.109.549303. Epub 2009 Jun 11. — View Citation
Stuart RM, Schmidt M, Kurtz P, Waziri A, Helbok R, Mayer SA, Lee K, Badjatia N, Hirsch LJ, Connolly ES, Claassen J. Intracranial multimodal monitoring for acute brain injury: a single institution review of current practices. Neurocrit Care. 2010 Apr;12(2):188-98. doi: 10.1007/s12028-010-9330-9. — View Citation
Ward JL, Harting MT, Cox CS Jr, Mercer DW. Effects of ketamine on endotoxin and traumatic brain injury induced cytokine production in the rat. J Trauma. 2011 Jun;70(6):1471-9. doi: 10.1097/TA.0b013e31821c38bd. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | brain glutamate concentrations | 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) | H0-H12, H12-H24, H24-H36 and H36-H48 | No |
Secondary | metabolic profile | 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. | H0-H12, H12-H24, H24-H36 and H36-H48 | No |
Secondary | Episodes of intracranial hypertension (ICHT) and brain ischemia | 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 | H0-H12, H12-H24, H24-H36 and H36-H48 | No |
Secondary | Therapeutic Intensity Level (TIL) | 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. | Days 1 and 2 | No |
Secondary | Glasgow Outcome Scale (GOS) et extended Glasgow Outcome Scale (eGOS) | 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. | 6 months and 1 year | No |
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