A Phase 4 interventional study of cisatracurium besilate and Placebo in Traumatic Brain Injury and Intracranial Hypertension, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by University Hospital, Clermont-Ferrand · Phase 4, Interventional, and Treatment
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.
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:
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 34 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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
To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.
Other: Placebo
area under the curve of the temporal evolution of intracranial pressure
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.
Time frame: at day 1
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
diffuse axonal injury, subarachnoid hemorrhage, intracerebral hematoma)
Time frame: at day 1
Monitoring of the curare effect
train of four and PTC
Time frame: at day 1
Course of ventilation parameters
tidal volume, FiO2, PEEP
Time frame: at day 1
Course of transcranial Doppler data
velocities
Time frame: at day 1
Course of arterial blood gas data
pH, paO2, paCO2, Excess Base, HCO3-
Time frame: at day 1
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
hypotension, myocardial ischemia
Time frame: at day 1
Occurrence of pulmonary complications
acute respiratory distress syndrome, pneumonia acquired under mechanical ventilation
Time frame: at day 1
Occurrence of renal complications
use of renal replacement therapy
Time frame: at day 1
Occurrence of infectious complications
Time frame: at day 1
Doses of vasopressors or catecholamines
Time frame: at day 1
Need to increase therapeutics
barbiturate coma, hypothermia, osmotherapy, decompressive craniectomy
Time frame: at day 1
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand