NCT02404779

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.

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
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

March 19, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2022

Completed
Last Updated

July 7, 2020

Status Verified

June 1, 2020

Enrollment Period

7 years

First QC Date

March 16, 2015

Last Update Submit

July 2, 2020

Conditions

Traumatic Brain InjuryIntracranial Hypertension

Keywords

ICUDeep sedationMechanical ventilationTraumatic brain injuryIntracranial hypertensionCisatracuriumNeuromuscular Blocking AgentRandomization versus placebo

Outcome Measures

Primary Outcomes (1)

  • 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.

    at day 1

Secondary Outcomes (15)

  • Course of intracranial and cerebral perfusion pressures and various cerebral monitoring data if available (SvjO2, PtiO2)

    at day 1

  • Monitoring of the time spent by intracranial pressure above 20 mmHg using continuous recording

    at day 1

  • Course of intracranial pressure based on the type of brain injury

    at day 1

  • Monitoring of the curare effect

    at day 1

  • Course of ventilation parameters

    at day 1

  • +10 more secondary outcomes

Study Arms (2)

CISATRACURIUM

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

cisatracurium besilateDRUG
CISATRACURIUM
PlaceboOTHER
PLACEBO

Eligibility Criteria

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

You may qualify if:

  • \- 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticIntracranial Hypertension

Interventions

cisatracurium

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2015

First Posted

April 1, 2015

Study Start

March 19, 2015

Primary Completion

March 19, 2022

Study Completion

June 18, 2022

Last Updated

July 7, 2020

Record last verified: 2020-06

Locations

FR(1)