Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients

NCT06620393 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MP-32-2024-2732
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Agitation is a frequent complication following traumatic braing injury in patients admitted to the intensive care unit. This agitation frequently results in the liberal use of rescue drugs such as antipsychotics, sedatives and opiates, which in turn may delay rehabilitation, liberation from mechanical ventilation and emergence from posttraumatic amnesia. Dexmedetomidine may be a better agent given it's light sedative properties. The main objective is to assess the feasibility of conducting a multicenter randomized controlled trial of dexmedetomidine following TBI in the ICU.

Conditions

Traumatic Brain Injury; Agitation,Psychomotor

Outcome Measures

Primary Outcomes (1)

• Protocol adherence

  Proportion of hours the drug was administered

  Through study completion, an average of 2 years

Secondary Outcomes (3)

• Trial recruitment

  Through study completion, an average of 2 years

• Blinding maintenance

  Through study completion, an average of 2 years

• Proportion of data collection completed

  Through study completion, an average of 2 years

Other Outcomes (6)

• ICU-days free of agitation or coma within 14 days following randomization

  During ICU stay up to 14 days

• Agitation-related event during the ICU stay

  Through study completion, an average of 2 years

• Proportion of patients and the number of days exposed to antipsychotics, benzodiazepines and physical restraints

  Through study completion, an average of 2 years

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

DEX (4 mcg/100 ml supplied by Juno Pharmaceuticals) will be initiated at a starting dose of 0.6 mcg/kg/hour and increased by 0.2 mcg/kg/hour every 30 minutes up to final dose of 1.4 mcg/kg/hour.

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

Matching placebo (NS 0.9% 100ml)

Drug: Placebo

Interventions

Dexmedetomidine DRUG

DEX 4 mcg/100 ml at a starting dose of 0.6 mcg/kg/hour and increased by 0.2 mcg/kg/hour every 30 minutes up to final dose of 1.4 mcg/kg/hour.

Also known as: Precedex

Dexmedetomidine

Placebo DRUG

NaCl 0.9% 100ml

Placebo

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years) admitted to ICU with a critically ill moderate or severe TBI patients. Severity of TBI will be determined with the first Glasgow Coma Score (GCS). TBI patients with polytrauma and patients undergoing neurosurgical interventions will be eligible.
• Undergoing mechanically ventilation (of any duration) at the time of assessment.
• Anticipated ICU stay of 48 hours or more.

You may not qualify if:

• Patients at very high risk of short-term mortality (e.g., GCS of 3 without sedation, or unreactive pupils, or declared brain-dead when assessed for eligibility and patients in whom there is a lack of commitment to ongoing life support
• Patients unable to communicate in English or French (interfering with posttraumatic amnesia assessments)
• Patients with cognitive impairment as per family evaluation
• Pregnant or breastfeeding
• Patients currently receiving DEX or clonidine
• Allergy, bradycardia or hypotension precluding use of dexmedetomidine as per treating physician

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• Canadian Critical Care Trials Group: collaborator

MeSH Terms

Conditions

Brain Injuries, Traumatic; Psychomotor Agitation

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Virginie Williams, PhD

CONTACT

514-338-2222; virginie.williams.cnmtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Clinical Professor

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share