Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
USA30226
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Remifentanil
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
07/06/2002
Overall study end date
30/06/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Critically ill patients requiring 3-10 days of mechanical ventilation.
Participant type(s)
Patient
Age group
Not Specified
Sex
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, United Kingdom
Study 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
ROR
Funders
Funder type
Industry
Funder name
GlaxoSmithKline (GSK)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/06/2005 | Yes | No |