A Centre-Randomized, Open-Label, Cross-Over Study to Compare the Pharmaco-Economic Consequences of an Ultiva (Remifentanil Hydrochloride) Based Regimen With Conventional Sedative Based Regimens in ICU Subjects Requiring Short-Term Mechanical Ventilation With Analgesia and Sedation

GlaxoSmithKline15 sites in 1 country224 target enrollmentStarted: September 1, 2004Last updated: October 16, 2008

Conditions

Drugs

Trial Snapshot

Phase: Phase 4
Status: Completed
Sponsor: GlaxoSmithKline
Enrollment: 224
Locations: 15
Primary Endpoint: Health Outcome: Duration of time on mechanical ventilation

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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.

Outcomes

Primary Outcomes

Health Outcome: Duration of time on mechanical ventilation

Secondary Outcomes

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

Investigators

Sponsor

GlaxoSmithKline

Sponsor Class

Industry

Study Sites (15)

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