Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
900 participants
INTERVENTIONAL
2005-10-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Dexmedetomidine
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Principal Investigators
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Jukka Takala, MD, PhD
Role: STUDY_CHAIR
University/University Hospital, Bern, Switzerland
Esko Ruokonen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kuopio University Hospital, Finland
Stephan Jakob, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bern, Switzerland
Locations
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Helsinki University Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Tampere University Hospital
Tampere, , Finland
Inselspital
Bern, , Switzerland
Countries
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References
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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.
Other Identifiers
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3005011
Identifier Type: -
Identifier Source: org_study_id