NCT00226785

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_3

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

November 14, 2006

Status Verified

November 1, 2006

First QC Date

September 23, 2005

Last Update Submit

November 10, 2006

Conditions

Conscious Sedation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Interventions

DexmedetomidineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Helsinki University Hospital

Helsinki, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Inselspital

Bern, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 18795253DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jukka Takala, MD, PhD

    University/University Hospital, Bern, Switzerland

    STUDY CHAIR

  • Esko Ruokonen, MD, PhD

    Kuopio University Hospital, Finland

    PRINCIPAL INVESTIGATOR

  • Stephan Jakob, MD, PhD

    University Hospital, Bern, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 27, 2005

Study Start

October 1, 2005

Study Completion

July 1, 2006

Last Updated

November 14, 2006

Record last verified: 2006-11

Locations

FI(3)CH(1)