Dexmedetomidine-based Sedation in Neurocritical Care Patients

NCT02252523 | Unknown Phase 2

• 2 other identifiers: CHU-2102013-004697-10
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Brain Injuries

Keywords

Feasibility study

Outcome Measures

Primary Outcomes (5)

• Hemodynamic events

  at day 1

• Adverse effects other than hemodynamic event

  at day 1

• Premature discontinuation of dexmedetomidine infusion

  at day 1

• Delirium assessed by CAM- ICU scale

  at day 1

• Withdrawal syndrome at dexmedetomidine discontinuation

  at day 1

Secondary Outcomes (3)

• Level of sedation assessed by the RASS scale from dexmedetomidine initation

  at day 1

• Dose of dexmedetomidine necessary to achieve the objectives of sedation

  at day 1

• Effective plasma concentration

  at day 1

Study Arms (1)

DEXMEDETOMIDINE

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

DEXMEDETOMIDINE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Patrick LACARIN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 30, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

FR (1)