Dexmedetomidine for Continuous Sedation

This study has been terminated.

Sponsor:

Information provided by:

Orion Corporation, Orion Pharma

ClinicalTrials.gov Identifier:

NCT00226785

First received: September 23, 2005

Last updated: November 10, 2006

Last verified: November 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 23, 2005

Last Updated Date

November 10, 2006

Start Date ^ICMJE

October 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Proportion of time during sedative infusion with a RASS score within the individually-prescribed target range.
Time from ICU admission to discharge.

Change History

Complete list of historical versions of study NCT00226785 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Dexmedetomidine for Continuous Sedation

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Conscious Sedation

Intervention ^ICMJE

Drug: Dexmedetomidine

Study Arm (s)

Not Provided

Publications *

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. Epub 2008 Sep 16.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

900

Completion Date

July 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00226785

Other Study ID Numbers ^ICMJE

3005011

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Orion Corporation, Orion Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Orion Corporation, Orion Pharma

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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