Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects
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
1 other identifier
interventional
224
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedOctober 16, 2008
October 1, 2008
September 8, 2005
October 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health Outcome: Duration of time on mechanical ventilation
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation.
You may not qualify if:
- ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (15)
GSK Investigational Site
's-Hertogenbosch, 5211 RW, Netherlands
GSK Investigational Site
Alkmaar, 1815 JD, Netherlands
GSK Investigational Site
Amsterdam, 1081 HV, Netherlands
GSK Investigational Site
Apeldoorn, 7334 DZ, Netherlands
GSK Investigational Site
Dordrecht, 3318 AT, Netherlands
GSK Investigational Site
Ede, 6716 RP, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Haarlem, 2035 RC, Netherlands
GSK Investigational Site
Helmond, 5707 HA, Netherlands
GSK Investigational Site
Hengelo, 7555 DL, Netherlands
GSK Investigational Site
Rotterdam, 3015 GJ, Netherlands
GSK Investigational Site
The Hague, 2512 VA, Netherlands
GSK Investigational Site
Tiel, 4002 WP, Netherlands
GSK Investigational Site
Venlo, 5912 BL, Netherlands
GSK Investigational Site
Zwolle, 8011 JW, Netherlands
Related Publications (1)
Al MJ, Hakkaart L, Tan SS, Bakker J. Cost-consequence analysis of remifentanil-based analgo-sedation vs. conventional analgesia and sedation for patients on mechanical ventilation in the Netherlands. Crit Care. 2010;14(6):R195. doi: 10.1186/cc9313. Epub 2010 Nov 1.
PMID: 21040558DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
September 1, 2004
Last Updated
October 16, 2008
Record last verified: 2008-10