Clinical trial NCT00226785: Dexmedetomidine for Continuous Sedation
Official title: A Prospective, Multi-Centre, Randomised, Double-Blind Comparison of Intravenous Dexmedetomidine With Propofol/Midazolam for Continuous Sedation (24 Hours to 14 Days) of Ventilated Patients in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Conscious Sedation
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-27
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range
measure: Time from ICU admission to discharge
Secondary outcomes:
measure: Nurse's assessment of subject communication
measure: Duration of mechanical ventilation, weaning time and ventilator-free days in ICU
measure: Length of total hospital stay
measure: Functional recovery during hospitalisation
measure: Need for rescue medication to maintain sedation
measure: Frequency of delirium
measure: Frequency of organ failures and failure-free days
measure: Frequency of critical illness polyneuropathy
measure: ICU- and in-hospital survival
measure: Cost of care in the ICU
measure: Total cost of hospitalisation
measure: Blood levels of dexmedetomidine seen with long-term treatment
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: University/University Hospital, Bern, Switzerland
name: Jukka Takala, MD, PhD
role: STUDY_CHAIR
affiliation: Kuopio University Hospital, Finland
name: Esko Ruokonen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bern, Switzerland
name: Stephan Jakob, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruokonen E, Parviainen I, Jakob SM, Nunes S, Kaukonen M, Shepherd ST, Sarapohja T, Bratty JR, Takala J; "Dexmedetomidine for Continuous Sedation" Investigators. Dexmedetomidine versus propofol/midazolam for long-term sedation during mechanical ventilation. Intensive Care Med. 2009 Feb;35(2):282-90. doi: 10.1007/s00134-008-1296-0. Epub 2008 Sep 16.