Dexmedetomidine for Continuous Sedation

NCT ID: NCT00226785

Last Updated: 2006-11-14

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-07-31

Brief Summary

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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

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Conditions

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Conscious Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

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

Site Status

Kuopio University Hospital

Kuopio, , Finland

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Inselspital

Bern, , Switzerland

Site Status

Countries

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Finland Switzerland

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.

Reference Type DERIVED
PMID: 18795253 (View on PubMed)

Other Identifiers

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3005011

Identifier Type: -

Identifier Source: org_study_id