Clinical Trial: Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents. A Controlled Randomized Study

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.


Detailed Summary:

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%).

Sponsor: University Hospital, Clermont-Ferrand

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Course of intracranial and cerebral perfusion pressures and various cerebral monitoring data if available (SvjO2, PtiO2) [ Time Frame: at day 1 ]
  • Monitoring of the time spent by intracranial pressure above 20 mmHg using continuous recording [ Time Frame: at day 1 ]
  • Course of intracranial pressure based on the type of brain injury [ Time Frame: at day 1 ]
    diffuse axonal injury, subarachnoid hemorrhage, intracerebral hematoma)
  • Monitoring of the curare effect [ Time Frame: at day 1 ]
    train of four and PTC
  • Course of ventilation parameters [ Time Frame: at day 1 ]
    tidal volume, FiO2, PEEP
  • Course of transcranial Doppler data [ Time Frame: at day 1 ]
    velocities
  • Course of arterial blood gas data [ Time Frame: at day 1 ]
    pH, paO2, paCO2, Excess Base, HCO3-
  • Course of plasma and cerebrospinal fluid concentrations of cistracurium and laudanosine [ Time Frame: at day 1 ]
  • Cerebrospinal fluid concentrations of cisatracurium and laudanosin in case of cerebrospinal fluid derivation [ Time Frame: at day 1 ]
  • Occurrence of cardiovascular complications [ Time Frame: at day 1 ]
    hypotension, myocardial ischemia
  • Occurrence of pulmonary complications [ Time Frame: at day 1 ]
    acute respiratory distress syndrome, pneumonia acquired under mechanical ventilation
  • Occurrence of renal complications [ Time Frame: at day 1 ]
    use of renal replacement therapy
  • Occurrence of infectious complications [ Time Frame: at day 1 ]
  • Doses of vasopressors or catecholamines [ Time Frame: at day 1 ]
  • Need to increase therapeutics [ Time Frame: at day 1 ]
    barbiturate coma, hypothermia, osmotherapy, decompressive craniectomy


Original Secondary Outcome: Same as current

Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: March 16, 2015
Date Started: March 2015
Date Completion: June 2016
Last Updated: September 18, 2015
Last Verified: September 2015