Last updated: 11/03/2018 10:05:36

Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)

GSK study ID
108701
See study documents
Clinicaltrials.gov ID
NCT00436345
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, open label, multicentre study to compare the pharmaco-economic implications of an analgesia based regimen with remifentanil and a conventional sedation based regimen using propofol in medical and post-surgical ICU subjects requiring mechanical ventilation for at least 2 days.
Trial description: This study will be a multicentre randomized, open-label, phase IIIb study. This study will evaluate two different techniques of sedation: an analgesia based regimen with remifentanil versus a conventional sedation based regimen using propofol in subjects that require mechanical ventilation for at least 2 days in the ICU. The conventional sedation based regimen will consist of propofol combined with an opioid according to routine clinical practice (morphine, fentanyl, sufentanil or other as required) . The analgesia based regimen will consist of remifentanil, with propofol added on if required.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Duration of time on mechanical ventilation (Intent-to-Treat Population)

Timeframe: Up to 38 days (912 hours)

Duration of time on mechanical ventilation (Modified-Intent-to-Treat Population)

Timeframe: Up to 38 days (912 hours)

Duration of time on mechanical ventilation (Per-Protocol Population)

Timeframe: Up to 38 days (912 hours)

Secondary outcomes:

Duration of time in Intensive Care Unit (ICU) and potential stay in ICU (the time expected for extubation, i.e., the time between intubation and eligibility for extubation, according to Investigator’s decision)

Timeframe: Up to 38 days (912 hours)

Duration of extubation

Timeframe: up to 38 days (912 hours)

Duration of weaning

Timeframe: up to 38 days (912 hours)

Duration of Remifentanil Infusion (ITT Population)

Timeframe: Up to 10 days (240 hours)

Duration of Propofol Infusion (ITT population)

Timeframe: up to 10 days (240 hours)

Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)

Timeframe: up to 10 days (240 hours)

Dose of Remifentanil administered – Continuous infusion

Timeframe: Up to 10 days

Doses of Sufentanil and Fentanil administered – Continuous infusion

Timeframe: up to 10 days

Dose of Propofol administered – Continuous infusion

Timeframe: Up to 10 days

Dose of Morphine administered – Continuous infusion

Timeframe: up to 10 days

Total dose of Propofol administered - Bolus

Timeframe: Up to 10 days

Total dose of Fentanil administered - Bolus

Timeframe: Up to 10 days

Number of participants analyzed for Sedation – Agitation Scale (SAS) and Pain Intensity (PI) scale

Timeframe: Up to 38 Days

Sedation-Agitation from Screening through the End of Study

Timeframe: Up to 38 days

Sedation-Agitation for Day 7

Timeframe: Day 7

Sedation-Agitation from Day 8 to Day 10

Timeframe: Days 8, 9, and 10

Number of participants analyzed for BIS (Bispectral Index Scale)

Timeframe: Up to 38 days

Bispectral Index (BIS)

Timeframe: Screening through End of Study, up to 38 days

Bispectral Index (BIS) for Day 5

Timeframe: Day 5

Bispectral Index (BIS) for Extubation Period and Post-Extubation Period

Timeframe: up to 38 days

Pain Intensity (PI)

Timeframe: Up to 38 days

Pain Intensity from Day 8 to Day 10

Timeframe: Days 8, 9, and 10

Interventions:
  • Drug: Remifentanil
  • Drug: Propofol
    • Enrollment:
    39
    Primary completion date:
    2008-23-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Analgesia
    Product
    remifentanil
    Collaborators
    Not applicable
    Study date(s)
    November 2007 to August 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
    • Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
    • Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
    • Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
    • Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid.
    Exclusion criteria:
    • Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
    • Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided

      • Concurrent medications: •Requires or is likely to require neuromuscular blocking agents by continuous infusion to facilitate mechanical ventilation •Has or is likely to receive an epidural block during the treatment period

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Udine, Friuli-Venezia-Giulia, Italy, 33100
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Roma, Lazio, Italy, 00161
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Palermo, Sicilia, Italy, 90127
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Ferrara, Emilia-Romagna, Italy, 44100
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Catanzaro, Calabria, Italy, 88100
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Napoli, Campania, Italy, 80131
    Status
    Terminated/Withdrawn
    Contact us

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2008-23-08
    Actual study completion date
    2008-23-08

    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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