Dexmedetomidine-based Sedation in Neurocritical Care Patients

September 26, 2014 updated by: University Hospital, Clermont-Ferrand

Feasibility of Dexmedetomidine-based Sedation in Neurocritical Care Patients : a Pilot Study

This will be an open, prospective pilot study with pharmacological analysis. This study is designed to assess the efficacity and safety of dexmedetomidine-based sedation in two subgroups of neurocritically ill patients requiring mechanical ventilation for more than 48 hours. Those with or at risk for intracranial hypertension requiring deep sedation and those requiring a light to moderate sedation for early neurological evaluation.

The main objective is to assess the feasability of dexmedetomidine infusion in terms of efficacy and safety (especially cardiovascular tolerance) in brain-injured patients admitted to intensive care unit and requiring sedation and mechanical ventilation for a predictable duration greater than or equal to 48 hours. Secondary objectives include the study of hemodynamic parameters evolution, dose-response relationship, blood (+/- cerebrospinal fluid) drug concentration, opioates and co-hypnotic consumption.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A written informed consent will be obtained from patients next-of-kin, before study enrollment according to inclusion and exclusion criterias. All consecutive brain-injured patients (traumatic brain injury, subarachnoid or intracerebral hemorrhage, postoperative neurosurgical procedure) admitted to our neurocritical care unit, older than 18 years and requiring sedation and analgesia for mechanical ventilation longer than 48 hours, will be eligible for the study. Depending on the absence or presence of lesion which may increase intracranial pressure, patients will be included in the "light to moderate" sedation subgroup (MLS) or in the "deep" sedation subgroup (DS).

In the MLS subgroup (RASS 0/-3), sedation and analgesia will be drived by propofol and opiates. Once the goals of sedation achieved with usual hypnotic, dexmedetomidine will be initiated at a dose of 0.5 μg/kg/h, and then gradually increased or decreased by increments of 0.1 μ g / kg / h all hours to a maximum dose of 1.4 μg/kg/h, depending on the target sedation achievement. Propofol will be discontinued at study drug initiation. Dexmedetomidine infusion will bemaintained at least during 48 hours, evaluation of the efficacy and safety will be continuous during this period.

After these first 48 hours, in the absence of neurological worsening requiring a deep sedation and if sedation's levels will are achieved with dexmedetomidine alone (ie without requirement of propofol continuous administration) , it will be maintained untill withdrawal of mechanical ventilation. Otherwise, study drug will discontinued and propofol will be restarted.

In the DS subgroup, "deep" sedation (RASS -4/-5) will be achieved by propofol infusion. If sedation level are not achieved with the maximum recommended propofol dose (5mg/kg/h), midazolam will be started to reach target sedation level with a maximum dose of 0.15mg/kg/h. Once the goals of sedation will be achieved a dexmedetomidine infusion will be initiated at a dose of 0.5 μg/kg/h and then gradually titrated by increase of 0.1 μg/kg/h every hour up to the maximum patient-tolerated dose (maximum dose of 1.4 μg/kg/h). Conventional hypnotic doses will be adjusted according to the sedation target. In parallel to dexmedetomidine titration, midazolam first and then propofol will be decreased. The study drug will be maintained at the maximum patient-tolerated dose for a total of 48 hours during which the efficacy and safety will be assessed continuously. After this period, dexmedetomidine will be discontinued. According to the patient's neurological evolution, either sedation objectives will remain identical (RASS -4/-5), or sedation will be decreased. Conventional hypnotic will be used again to achieve these objectives.

The expected result of this study is to confirm that the administration of dexmedetomidine is effective and safe for "light to moderate" and "deep" sedation of brain-injured patients admitted to intensive care unit. In addition, this feasibility study could provide legitimacy if the results are conclusive, to conduct a prospective multicenter randomized controlled trial on the potential benefits of dexmedetomidine in neurocritical ill patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Chu Clermont-Ferrand
        • Principal Investigator:
          • Jean-Michel CONSTANTIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Brain-injured patients (traumatic brain injury, subarachnoid or intracerebral hemorrhage, postoperative neurosurgical procedure)
  • Older than 18 years
  • Requiring sedation and analgesia for mechanical ventilation longer than 48 hours
  • Written informed consent obtained from patients next-of-kin, before study enrollment
  • Depending on the absence or presence of lesion which may increase intracranial pressure, patients will be included in the "light to moderate" sedation subgroup or in the "deep" sedation subgroup

Exclusion Criteria:

  • - Heart rate < 45 bpm,
  • Uncontrolled shock or cardiac failure,
  • High-grade AV block,
  • Acute ischemic neurological injury,
  • Severe liver failure,
  • Drug overdose and prior enrollment in a trial with any experimental drug in the last 30 days,
  • Need for ongoing neuromuscular blockade except for tracheal intubation,
  • Pregnancy/lactation,
  • Known allergic reaction to dexmedetomidine,
  • Uncontrolled diabetes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DEXMEDETOMIDINE
Drug: Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hemodynamic events
Time Frame: at day 1
at day 1
Adverse effects other than hemodynamic event
Time Frame: at day 1
at day 1
Premature discontinuation of dexmedetomidine infusion
Time Frame: at day 1
at day 1
Delirium assessed by CAM- ICU scale
Time Frame: at day 1
at day 1
Withdrawal syndrome at dexmedetomidine discontinuation
Time Frame: at day 1
at day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Level of sedation assessed by the RASS scale from dexmedetomidine initation
Time Frame: at day 1
at day 1
Dose of dexmedetomidine necessary to achieve the objectives of sedation
Time Frame: at day 1
at day 1
Effective plasma concentration
Time Frame: at day 1
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Orion Corporation, Orion Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHU-210
  • 2013-004697-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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