Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents (THIC Cu)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02404779
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : April 1, 2015
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

Severely brain injured patients are at high risk of intracranial hypertension. Among medical treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but not english speaking societies.

Effects of NMBA are unknown. The present study is designed to compare the effects of NMBA versus placebo in the treatment of intracranial hypertension, and the underlying physiopathologic effects.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Intracranial Hypertension Drug: cisatracurium besilate Phase 4

Detailed Description:

In case of intracranial hypertension, french neurocritical care society argue for the use of neuromuscular blocking agents before osmotherapy, barbituric coma, hypothermia and craniectomy.

English speaking societies don't sustain this approach. Since then, the use of NMBA remains controversial in case of intracranial hypertension and no study is available.

We propose to study severely brain injured patients presenting with intracranial hypertension and treat them with cisatracurium besilate or placebo.

Our hypothesis is that neuromuscular blockade might act on several parameters:

  • Hemodynamics
  • respiratory parameters, mechanical ventilation and blood gaz analysis
  • cerebral velocities
  • diminished O2 peripheral consumption
  • cerebrospinal diffusion and concentration of cisatracurium and a metabolite laudanosine We wish to assess changes in ICP according to the above parameters in a controlled randomized non blinded fashion against placebo (NaCl 0,9%).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents. A Controlled Randomized Study Versus Placebo
Study Start Date : March 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CISATRACURIUM
To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.
Drug: cisatracurium besilate
Placebo Comparator: PLACEBO
To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.



Primary Outcome Measures :
  1. area under the curve of the temporal evolution of intracranial pressure [ Time Frame: at day 1 ]
    The primary outcome is the area under the curve of the temporal evolution of intracranial pressure, over a period of 30 minutes after the administration of neuromuscular blocking agent or placebo.


Secondary Outcome Measures :
  1. Course of intracranial and cerebral perfusion pressures and various cerebral monitoring data if available (SvjO2, PtiO2) [ Time Frame: at day 1 ]
  2. Monitoring of the time spent by intracranial pressure above 20 mmHg using continuous recording [ Time Frame: at day 1 ]
  3. Course of intracranial pressure based on the type of brain injury [ Time Frame: at day 1 ]
    diffuse axonal injury, subarachnoid hemorrhage, intracerebral hematoma)

  4. Monitoring of the curare effect [ Time Frame: at day 1 ]
    train of four and PTC

  5. Course of ventilation parameters [ Time Frame: at day 1 ]
    tidal volume, FiO2, PEEP

  6. Course of transcranial Doppler data [ Time Frame: at day 1 ]
    velocities

  7. Course of arterial blood gas data [ Time Frame: at day 1 ]
    pH, paO2, paCO2, Excess Base, HCO3-

  8. Course of plasma and cerebrospinal fluid concentrations of cistracurium and laudanosine [ Time Frame: at day 1 ]
  9. Cerebrospinal fluid concentrations of cisatracurium and laudanosin in case of cerebrospinal fluid derivation [ Time Frame: at day 1 ]
  10. Occurrence of cardiovascular complications [ Time Frame: at day 1 ]
    hypotension, myocardial ischemia

  11. Occurrence of pulmonary complications [ Time Frame: at day 1 ]
    acute respiratory distress syndrome, pneumonia acquired under mechanical ventilation

  12. Occurrence of renal complications [ Time Frame: at day 1 ]
    use of renal replacement therapy

  13. Occurrence of infectious complications [ Time Frame: at day 1 ]
  14. Doses of vasopressors or catecholamines [ Time Frame: at day 1 ]
  15. Need to increase therapeutics [ Time Frame: at day 1 ]
    barbiturate coma, hypothermia, osmotherapy, decompressive craniectomy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Age over 18
  • Mechanical ventilation and deep sedation
  • Severe traumatic brain injury
  • Intracranial hypertension (ICP > 20 mmHg during > 15 minutes)
  • Intracranial pressure monitoring
  • Hemodynamically stable

Exclusion Criteria:

  • - History of anaphylaxia with neuromuscular agents
  • Hemodynamic instability
  • Pregnant and/or breast feeding women

Information from the National Library of Medicine

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): NCT02404779


Contacts
Layout table for location contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Sophie KAUFFMANN         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand

Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02404779     History of Changes
Other Study ID Numbers: CHU-0225
2014-004951-30 ( EudraCT Number )
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: September 21, 2015
Last Verified: September 2015
Keywords provided by University Hospital, Clermont-Ferrand:
ICU
Deep sedation
Mechanical ventilation
Traumatic brain injury
Intracranial hypertension
Cisatracurium
Neuromuscular Blocking Agent
Randomization versus placebo
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Intracranial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cisatracurium
Atracurium
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neuromuscular Nondepolarizing Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action