Clinical trial NCT00436345: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Analgesia
Keywords: analgesia
Mechanical ventilation
pharmaco-economic
ICU
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
timeFrame: Up to 38 days (912 hours)
measure: Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)
timeFrame: Up to 38 days (912 hours)
measure: Duration of Time on Mechanical Ventilation (Per-Protocol Population)
timeFrame: Up to 38 days (912 hours)
Secondary outcomes:
measure: 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)
measure: Duration of Extubation
timeFrame: up to 38 days (912 hours)
measure: Duration of Weaning
timeFrame: up to 38 days (912 hours)
measure: Duration of Remifentanil Infusion (ITT Population)
timeFrame: Up to 10 days (240 hours)
measure: Duration of Propofol Infusion (ITT Population)
timeFrame: up to 10 days (240 hours)
measure: Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)
timeFrame: up to 10 days (240 hours)
measure: Dose of Remifentanil Administered - Continuous Infusion
timeFrame: Up to 10 days
measure: Doses of Sufentanil and Fentanil Administered - Continuous Infusion
timeFrame: up to 10 days
measure: Dose of Propofol Administered - Continuous Infusion
timeFrame: Up to 10 days
measure: Dose of Morphine Administered - Continuous Infusion
timeFrame: up to 10 days
measure: Total Dose of Propofol Administered - Bolus
timeFrame: Up to 10 days
measure: Total Dose of Fentanil Administered - Bolus
timeFrame: Up to 10 days
measure: Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale
timeFrame: Up to 38 Days
measure: Sedation-Agitation From Screening Through the End of Study
timeFrame: Up to 38 days
measure: Sedation-Agitation for Day 7
timeFrame: Day 7
measure: Sedation-Agitation From Day 8 to Day 10
timeFrame: Days 8, 9, and 10
measure: Number of Participants Analyzed for BIS (Bispectral Index Scale)
timeFrame: Up to 38 days
measure: Bispectral Index (BIS)
timeFrame: Screening through End of Study, up to 38 days
measure: Bispectral Index (BIS) for Day 5
timeFrame: Day 5
measure: Bispectral Index (BIS) for Extubation Period and Post-Extubation Period
timeFrame: up to 38 days
measure: Pain Intensity (PI)
timeFrame: Up to 38 days
measure: Pain Intensity From Day 8 to Day 10
timeFrame: Days 8, 9, and 10
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: GSK Investigational Site
state: Calabria
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Ferrara
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Udine
country: Italy
facility: GSK Investigational Site
state: Friuli-Venezia-Giulia
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Palermo
country: Italy
facility: GSK Investigational Site
state: Sicilia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: