Dexmedetomidine for Continuous Sedation

Phase 3TerminatedNCT00226785

Orion Corporation, Orion Pharma900 enrolled

Overview

The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of sedation in long-stay intensive care unit (ICU) patients, and that dexmedetomidine, compared with current best practice, reduces the length of ICU stay.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

900

Conditions

Conscious Sedation

Interventions

DexmedetomidineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical need for sedation and mechanical ventilation * Receiving full intensive care life support * Expected stay in ICU of at least 48 hours (h) from time of admission * Expected requirement for sedation of at least 24h from time of randomisation * Written informed consent within 36h of ICU admission Exclusion Criteria: * Acute severe neurological disorder * Acute uncompensated circulatory failure at time of randomisation * Severe bradycardia * Atrioventricular (AV) conduction block (II-III) unless pacemaker fitted * Severe hepatic impairment * Need for muscle relaxation at time of randomisation * Loss of hearing or vision or any condition interfering significantly with RASS assessment * Positive pregnancy test or currently lactating

Locations (4)

Helsinki University Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Tampere University Hospital

Tampere, Finland

Inselspital

Bern, Switzerland

Outcomes

Primary Outcomes

Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range

Time from ICU admission to discharge

Secondary Outcomes

Nurse's assessment of subject communication

Duration of mechanical ventilation, weaning time and ventilator-free days in ICU

Length of total hospital stay

Functional recovery during hospitalisation

Need for rescue medication to maintain sedation

Frequency of delirium

Frequency of organ failures and failure-free days

Frequency of critical illness polyneuropathy

ICU- and in-hospital survival

Cost of care in the ICU

Total cost of hospitalisation

Blood levels of dexmedetomidine seen with long-term treatment

Data from ClinicalTrials.gov

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