Status:
TERMINATED
Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Analgesia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 conventi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00436345
Start Date
November 1 2007
End Date
September 1 2008
Last Update
May 30 2017
Active Locations (6)
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1
GSK Investigational Site
Catanzaro, Calabria, Italy, 88100
2
GSK Investigational Site
Napoli, Campania, Italy, 80131
3
GSK Investigational Site
Ferrara, Emilia-Romagna, Italy, 44100
4
GSK Investigational Site
Udine, Friuli Venezia Giulia, Italy, 33100