Condition category
Surgery
Date applied
09/02/2005
Date assigned
09/02/2005
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Kirkham

ORCID ID

Contact details

GlaxoSmithKline
Greenford Road
Greenford
Middlesex
UB6 OHE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

USA30226

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Medical or surgical patients requiring intensive care.

Intervention

Comparing analgesia-based sedation using remifentanil versus standard hypnotic-based sedation for up to 10 days in intensive care unit patients. Titration of analgesia/sedation to achieve optimal sedation. Regular assessments of haemodynamics.

Intervention type

Drug

Phase

Not Specified

Drug names

Remifentanil

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/06/2002

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Critically ill patients requiring 3-10 days of mechanical ventilation.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

07/06/2002

Recruitment end date

30/06/2003

Locations

Countries of recruitment

Austria, Belgium, Denmark, France, Germany, Greece, Iran, Netherlands, Portugal, United Arab Emirates

Trial participating centre

GlaxoSmithKline
Greenford, Middlesex
UB6 OHE
United Kingdom

Sponsor information

Organisation

GlaxoSmithKline

Sponsor details

Greenford Road
Greenford
UB6 0HE
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

GlaxoSmithKline (GSK)

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15987391

Publication citations

  1. Results

    Breen D, Karabinis A, Malbrain M, Morais R, Albrecht S, Jarnvig IL, Parkinson P, Kirkham AJ, Decreased duration of mechanical ventilation when comparing analgesia-based sedation using remifentanil with standard hypnotic-based sedation for up to 10 days in intensive care unit patients: a randomised trial [ISRCTN47583497]., Crit Care, 2005, 9, 3, R200-10, doi: 10.1186/cc3495.

Additional files

Editorial Notes