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

This study has been terminated.
(recruitment issues)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00436345
First received: February 15, 2007
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Analgesia
Drug: Remifentanil
Drug: Propofol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Duration of Time on Mechanical Ventilation (Intent-to-Treat Population) [ Time Frame: Up to 38 days (912 hours) ] [ Designated as safety issue: No ]
    Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).

  • Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population) [ Time Frame: Up to 38 days (912 hours) ] [ Designated as safety issue: No ]
    Time from start of mechanical ventilation until actual extubation.

  • Duration of Time on Mechanical Ventilation (Per-Protocol Population) [ Time Frame: Up to 38 days (912 hours) ] [ Designated as safety issue: No ]
    Time from start of mechanical ventilation until actual extubation


Secondary Outcome Measures:
  • 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) [ Time Frame: Up to 38 days (912 hours) ] [ Designated as safety issue: No ]
    Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.

  • Duration of Extubation [ Time Frame: up to 38 days (912 hours) ] [ Designated as safety issue: No ]
    Duration of extubation was measured.

  • Duration of Weaning [ Time Frame: up to 38 days (912 hours) ] [ Designated as safety issue: No ]
    Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.

  • Duration of Remifentanil Infusion (ITT Population) [ Time Frame: Up to 10 days (240 hours) ] [ Designated as safety issue: No ]
    Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.

  • Duration of Propofol Infusion (ITT Population) [ Time Frame: up to 10 days (240 hours) ] [ Designated as safety issue: No ]
    Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.

  • Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population) [ Time Frame: up to 10 days (240 hours) ] [ Designated as safety issue: No ]
    Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.

  • Dose of Remifentanil Administered - Continuous Infusion [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
    Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.

  • Doses of Sufentanil and Fentanil Administered - Continuous Infusion [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.

  • Dose of Propofol Administered - Continuous Infusion [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
    Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.

  • Dose of Morphine Administered - Continuous Infusion [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
    Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.

  • Total Dose of Propofol Administered - Bolus [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
    Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.

  • Total Dose of Fentanil Administered - Bolus [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
    Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.

  • Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale [ Time Frame: Up to 38 Days ] [ Designated as safety issue: No ]
    Data from participants in the study for which the Sedation-Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.

  • Sedation-Agitation From Screening Through the End of Study [ Time Frame: Up to 38 days ] [ Designated as safety issue: No ]
    "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.

  • Sedation-Agitation for Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.

  • Sedation-Agitation From Day 8 to Day 10 [ Time Frame: Days 8, 9, and 10 ] [ Designated as safety issue: No ]
    "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.

  • Number of Participants Analyzed for BIS (Bispectral Index Scale) [ Time Frame: Up to 38 days ] [ Designated as safety issue: No ]
    Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.

  • Bispectral Index (BIS) [ Time Frame: Screening through End of Study, up to 38 days ] [ Designated as safety issue: No ]
    The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.

  • Bispectral Index (BIS) for Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.

  • Bispectral Index (BIS) for Extubation Period and Post-Extubation Period [ Time Frame: up to 38 days ] [ Designated as safety issue: No ]
    The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.

  • Pain Intensity (PI) [ Time Frame: Up to 38 days ] [ Designated as safety issue: No ]
    "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.

  • Pain Intensity From Day 8 to Day 10 [ Time Frame: Days 8, 9, and 10 ] [ Designated as safety issue: No ]
    "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.


Enrollment: 39
Study Start Date: November 2007
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remifentanil
remifentanil
Drug: Remifentanil
analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation
Active Comparator: Propofol
Propofol infusion
Drug: Propofol
conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436345

Locations
Italy
GSK Investigational Site
Catanzaro, Calabria, Italy, 88100
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Ferrara, Emilia-Romagna, Italy, 44100
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
GSK Investigational Site
Roma, Lazio, Italy, 00161
GSK Investigational Site
Palermo, Sicilia, Italy, 90127
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00436345     History of Changes
Other Study ID Numbers: 108701
Study First Received: February 15, 2007
Results First Received: August 7, 2009
Last Updated: March 17, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by GlaxoSmithKline:
analgesia
Mechanical ventilation
pharmaco-economic
ICU

Additional relevant MeSH terms:
Remifentanil
Propofol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 30, 2014