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Dexmedetomidine for Continuous Sedation

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00226785
First Posted: September 27, 2005
Last Update Posted: November 14, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Orion Corporation, Orion Pharma
  Purpose
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.

Condition Intervention Phase
Conscious Sedation Drug: Dexmedetomidine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 900
Study Start Date: October 2005
Estimated Study Completion Date: July 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226785


Locations
Finland
Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
Switzerland
Inselspital
Bern, Switzerland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Study Chair: Jukka Takala, MD, PhD University/University Hospital, Bern, Switzerland
Principal Investigator: Esko Ruokonen, MD, PhD Kuopio University Hospital, Finland
Principal Investigator: Stephan Jakob, MD, PhD University Hospital, Bern, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00226785     History of Changes
Other Study ID Numbers: 3005011
First Submitted: September 23, 2005
First Posted: September 27, 2005
Last Update Posted: November 14, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action