Back to resultsPharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)
Primary Purpose
Analgesia
Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Remifentanil
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia focused on measuring analgesia, Mechanical ventilation, pharmaco-economic, ICU
Eligibility 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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remifentanil
Propofol
Arm Description
remifentanil
Propofol infusion
Outcomes
Primary Outcome Measures
Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
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 from start of mechanical ventilation until actual extubation.
Duration of Time on Mechanical Ventilation (Per-Protocol Population)
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)
Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.
Duration of Extubation
Duration of extubation was measured.
Duration of Weaning
Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.
Duration of Remifentanil Infusion (ITT Population)
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)
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)
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
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
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
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
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
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
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
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
"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
"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
"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)
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)
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
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
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)
"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
"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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00436345
Brief Title
Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
recruitment issues
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
analgesia, Mechanical ventilation, pharmaco-economic, ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil
Arm Type
Experimental
Arm Description
remifentanil
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Propofol infusion
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical
Primary Outcome Measure Information:
Title
Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
Description
Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).
Time Frame
Up to 38 days (912 hours)
Title
Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)
Description
Time from start of mechanical ventilation until actual extubation.
Time Frame
Up to 38 days (912 hours)
Title
Duration of Time on Mechanical Ventilation (Per-Protocol Population)
Description
Time from start of mechanical ventilation until actual extubation
Time Frame
Up to 38 days (912 hours)
Secondary Outcome Measure Information:
Title
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)
Description
Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.
Time Frame
Up to 38 days (912 hours)
Title
Duration of Extubation
Description
Duration of extubation was measured.
Time Frame
up to 38 days (912 hours)
Title
Duration of Weaning
Description
Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.
Time Frame
up to 38 days (912 hours)
Title
Duration of Remifentanil Infusion (ITT Population)
Description
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.
Time Frame
Up to 10 days (240 hours)
Title
Duration of Propofol Infusion (ITT Population)
Description
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.
Time Frame
up to 10 days (240 hours)
Title
Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)
Description
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.
Time Frame
up to 10 days (240 hours)
Title
Dose of Remifentanil Administered - Continuous Infusion
Description
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame
Up to 10 days
Title
Doses of Sufentanil and Fentanil Administered - Continuous Infusion
Description
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame
up to 10 days
Title
Dose of Propofol Administered - Continuous Infusion
Description
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame
Up to 10 days
Title
Dose of Morphine Administered - Continuous Infusion
Description
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame
up to 10 days
Title
Total Dose of Propofol Administered - Bolus
Description
Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame
Up to 10 days
Title
Total Dose of Fentanil Administered - Bolus
Description
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame
Up to 10 days
Title
Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale
Description
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.
Time Frame
Up to 38 Days
Title
Sedation-Agitation From Screening Through the End of Study
Description
"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.
Time Frame
Up to 38 days
Title
Sedation-Agitation for Day 7
Description
"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.
Time Frame
Day 7
Title
Sedation-Agitation From Day 8 to Day 10
Description
"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.
Time Frame
Days 8, 9, and 10
Title
Number of Participants Analyzed for BIS (Bispectral Index Scale)
Description
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.
Time Frame
Up to 38 days
Title
Bispectral Index (BIS)
Description
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.
Time Frame
Screening through End of Study, up to 38 days
Title
Bispectral Index (BIS) for Day 5
Description
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.
Time Frame
Day 5
Title
Bispectral Index (BIS) for Extubation Period and Post-Extubation Period
Description
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.
Time Frame
up to 38 days
Title
Pain Intensity (PI)
Description
"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.
Time Frame
Up to 38 days
Title
Pain Intensity From Day 8 to Day 10
Description
"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.
Time Frame
Days 8, 9, and 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44100
Country
Italy
Facility Name
GSK Investigational Site
City
Udine
State/Province
Friuli-Venezia-Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
GSK Investigational Site
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)
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