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

Primary Purpose

Traumatic Brain Injury, Intracranial Hypertension

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
cisatracurium besilate
Placebo
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring ICU, Deep sedation, Mechanical ventilation, Traumatic brain injury, Intracranial hypertension, Cisatracurium, Neuromuscular Blocking Agent, Randomization versus placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CISATRACURIUM

PLACEBO

Arm Description

To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.

To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2015
Last Updated
July 2, 2020
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02404779
Brief Title
Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents
Acronym
THIC Cu
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 Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 19, 2015 (Actual)
Primary Completion Date
March 19, 2022 (Anticipated)
Study Completion Date
June 18, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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 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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Intracranial Hypertension
Keywords
ICU, Deep sedation, Mechanical ventilation, Traumatic brain injury, Intracranial hypertension, Cisatracurium, Neuromuscular Blocking Agent, Randomization versus placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CISATRACURIUM
Arm Type
Experimental
Arm Description
To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.
Intervention Type
Drug
Intervention Name(s)
cisatracurium besilate
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
area under the curve of the temporal evolution of intracranial pressure
Description
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
Secondary Outcome Measure Information:
Title
Course of intracranial and cerebral perfusion pressures and various cerebral monitoring data if available (SvjO2, PtiO2)
Time Frame
at day 1
Title
Monitoring of the time spent by intracranial pressure above 20 mmHg using continuous recording
Time Frame
at day 1
Title
Course of intracranial pressure based on the type of brain injury
Description
diffuse axonal injury, subarachnoid hemorrhage, intracerebral hematoma)
Time Frame
at day 1
Title
Monitoring of the curare effect
Description
train of four and PTC
Time Frame
at day 1
Title
Course of ventilation parameters
Description
tidal volume, FiO2, PEEP
Time Frame
at day 1
Title
Course of transcranial Doppler data
Description
velocities
Time Frame
at day 1
Title
Course of arterial blood gas data
Description
pH, paO2, paCO2, Excess Base, HCO3-
Time Frame
at day 1
Title
Course of plasma and cerebrospinal fluid concentrations of cistracurium and laudanosine
Time Frame
at day 1
Title
Cerebrospinal fluid concentrations of cisatracurium and laudanosin in case of cerebrospinal fluid derivation
Time Frame
at day 1
Title
Occurrence of cardiovascular complications
Description
hypotension, myocardial ischemia
Time Frame
at day 1
Title
Occurrence of pulmonary complications
Description
acute respiratory distress syndrome, pneumonia acquired under mechanical ventilation
Time Frame
at day 1
Title
Occurrence of renal complications
Description
use of renal replacement therapy
Time Frame
at day 1
Title
Occurrence of infectious complications
Time Frame
at day 1
Title
Doses of vasopressors or catecholamines
Time Frame
at day 1
Title
Need to increase therapeutics
Description
barbiturate coma, hypothermia, osmotherapy, decompressive craniectomy
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Sophie KAUFFMANN

12. IPD Sharing Statement

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

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