Last updated: 11/02/2018 23:38:31

Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects

GSK study ID
101653
See study documents
Clinicaltrials.gov ID
NCT00158873
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A centre-randomized, open-label, cross-over study to compare the pharmaco-economic consequences of an Ultiva (remifentanil hydrochloride) based regimen with conventional sedative based regimens in ICU subjects requiring short-term mechanical ventilation with analgesia and sedation
Trial description: The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU, difference in extubation time and use of concomitant sedative agents.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: midazolam
  • Drug: lorazepam
  • Drug: fentanyl
  • Drug: morphine
  • Drug: remifentanil
  • Drug: propofol
    • Enrollment:
    224
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sedation
    Product
    remifentanil
    Collaborators
    Not applicable
    Study date(s)
    September 2004 to October 2005
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    no
    • ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation.
    • ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation.
    Exclusion criteria:
    • ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    ALKMAAR, Netherlands, 1815 JD
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    DEN HAAG, Netherlands, 2512 VA
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    EINDHOVEN, Netherlands, 5623 EJ
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    DORDRECHT, Netherlands, 3318 AT
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    EDE, Netherlands, 6716 RP
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    HAARLEM, Netherlands, 2035 RC
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 15 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-21-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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