Acute Brain InjuriesPhase 2NCT02252523
Dexmedetomidine-based Sedation in Neurocritical Care Patients
A Phase 2 study testing Dexmedetomidine in people with Acute Brain Injuries, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injuries
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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,
Show all 10Show fewer
- Need for ongoing neuromuscular blockade except for tracheal intubation,
- Pregnancy/lactation,
- Known allergic reaction to dexmedetomidine,
- Uncontrolled diabetes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Jean-Michel CONSTANTIN
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Brain Injuries
- Being tested
- Dexmedetomidine
- Keywords
- Feasibility study
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| DEXMEDETOMIDINE | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic events
Measured: at day 1
Adverse effects other than hemodynamic event
Measured: at day 1
Premature discontinuation of dexmedetomidine infusion
Measured: at day 1
Delirium assessed by CAM- ICU scale
Measured: at day 1
Withdrawal syndrome at dexmedetomidine discontinuation
Measured: at day 1
Secondary outcomes (3)
Level of sedation assessed by the RASS scale from dexmedetomidine initation
Measured: at day 1
Dose of dexmedetomidine necessary to achieve the objectives of sedation
Measured: at day 1
Effective plasma concentration
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252523
- Sponsor's protocol ID
- CHU-210
- Other IDs
- 2013-004697-10
- Status last verified
- Sep 2014
- First submitted
- 26 Sep 2014
- Last updated
- 30 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Dexmedetomidine-based Sedation in Neurocritical Care Patients : a Pilot Study
- ClinicalTrials.gov ID
- NCT02252523
- Acronym / sponsor ID
- CHU-210
- Conditions
- Acute Brain Injuries
- Keywords
- Feasibility study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEXMEDETOMIDINE | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- - Heart rate < 45 bpm,
- Uncontrolled shock or cardiac failure,
- High-grade AV block,
- Acute ischemic neurological injury,
- Severe liver failure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine | Drug | DEXMEDETOMIDINE |
Primary outcome
Hemodynamic events
Time frame: at day 1
Adverse effects other than hemodynamic event
Time frame: at day 1
Premature discontinuation of dexmedetomidine infusion
Time frame: at day 1
Delirium assessed by CAM- ICU scale
Time frame: at day 1
Withdrawal syndrome at dexmedetomidine discontinuation
Time frame: at day 1
3 secondary outcomes
Level of sedation assessed by the RASS scale from dexmedetomidine initation
Time frame: at day 1
Dose of dexmedetomidine necessary to achieve the objectives of sedation
Time frame: at day 1
Effective plasma concentration
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine in people with Acute Brain Injuries, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic events (time frame: at day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.