Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects

Phase 4

Completed

• Conditions: Sedation

• Registration Number: NCT00158873
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU, difference in extubation time and use of concomitant sedative agents.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-15
• Last Update Posted: 2008-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation.

Exclusion criteria:

• ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Health Outcome: Duration of time on mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Health Outcome: length of stay in ICU, in hospital, requirement of opioid and sedative agents, duration of extubation process. Safety: haemodynamics and adverse events. Efficacy: sedation and pain scores

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇱 Zwolle, Netherlands