Dexmedetomidine for Continuous Sedation
Information source: Orion Corporation, Orion Pharma
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Conscious Sedation
Intervention: Dexmedetomidine (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Orion Corporation, Orion Pharma Official(s) and/or principal investigator(s):
Jukka Takala, MD, PhD, Study Chair, Affiliation: University/University Hospital, Bern, Switzerland
Esko Ruokonen, MD, PhD, Principal Investigator, Affiliation: Kuopio University Hospital, Finland
Stephan Jakob, MD, PhD, Principal Investigator, Affiliation: University Hospital, Bern, Switzerland
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target rangeTime from ICU admission to discharge
Secondary outcome: Nurse's assessment of subject communicationDuration 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Kuopio University Hospital, Kuopio, Finland
Tampere University Hospital, Tampere, Finland
Helsinki University Hospital, Helsinki, Finland
Inselspital, Bern, Switzerland
Additional Information
Starting date: October 2005
Ending date: July 2006
Last updated: November 10, 2006
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