NCT02232347

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

September 2, 2014

Last Update Submit

September 2, 2014

Conditions

Head Trauma

Keywords

traumatic brain injuryketaminemicrodialysisPtiO2glutamate

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • metabolic profile

    H0-H12, H12-H24, H24-H36 and H36-H48

  • Episodes of intracranial hypertension (ICHT) and brain ischemia

    H0-H12, H12-H24, H24-H36 and H36-H48

  • Therapeutic Intensity Level (TIL)

    Days 1 and 2

  • Glasgow Outcome Scale (GOS) et extended Glasgow Outcome Scale (eGOS)

    6 months and 1 year

Study Arms (2)

ketamine

EXPERIMENTAL

ketamine 5 mg/kg/h, continuous infusion for 48 hours

Drug: Ketamine

sufentanil

ACTIVE COMPARATOR

sufentanil 0,5 mcg/kg/h, continuous infusion for 48 hours

Drug: Sufentanil

Interventions

KetamineDRUG
ketamine
SufentanilDRUG
sufentanil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sainte Anne Military Teaching Hospital

Toulon, 83130, France

Location

Related Publications (13)

  • 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. doi: 10.1089/neu.2007.9995. No abstract available.

    PMID: 17511549BACKGROUND

  • 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.

    PMID: 22101599BACKGROUND

  • 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. doi: 10.1017/s1481803500012197. No abstract available.

    PMID: 20219164BACKGROUND

  • 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. No abstract available.

    PMID: 19640746BACKGROUND

  • 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.

    PMID: 21817985BACKGROUND

  • 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.

    PMID: 21926656BACKGROUND

  • 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.

    PMID: 19520992BACKGROUND

  • 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.

    PMID: 22056157BACKGROUND

  • 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.

    PMID: 22720148BACKGROUND

  • 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.

    PMID: 20107926BACKGROUND

  • Bourgoin A, Albanese 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. doi: 10.1097/01.CCM.0000044505.24727.16.

    PMID: 12626974BACKGROUND

  • Bourgoin A, Albanese J, Leone 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. doi: 10.1097/01.ccm.0000162491.26292.98.

    PMID: 15891344BACKGROUND

  • 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.

    PMID: 20113156BACKGROUND

MeSH Terms

Conditions

Craniocerebral TraumaBrain Injuries, Traumatic

Interventions

KetamineSufentanil

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ambroise MONTCRIOL, MD

    Direction Centrale du Service de Santé des Armées

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ambroise MONTCRIOL, MD

CONTACT

0483162358ambroise.montcriol@free.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 5, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

May 1, 2017

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations

FR(1)