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
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
-
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.