Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sedation
Intervention: midazolam (Drug); lorazepam (Drug); fentanyl (Drug); morphine (Drug); remifentanil (Drug); propofol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: Health Outcome: Duration of time on mechanical ventilation
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Clinical Trials Call Center, HERTOGENBOSCH 5200 ME, Netherlands
GSK Clinical Trials Call Center, Amsterdam 1007 MB, Netherlands
GSK Clinical Trials Call Center, Zwolle 8011 JW, Netherlands
GSK Clinical Trials Call Center, Tiel 4002 WP, Netherlands
GSK Clinical Trials Call Center, Haarlem 2035 RC, Netherlands
GSK Clinical Trials Call Center, Dordrecht 3318 AT, Netherlands
GSK Clinical Trials Call Center, Rotterdam 3015 GD, Netherlands
GSK Clinical Trials Call Center, Apeldoorn 7334 DZ, Netherlands
GSK Clinical Trials Call Center, Helmond 5707 HA, Netherlands
GSK Clinical Trials Call Center, Hengelo 7555 DL, Netherlands
GSK Clinical Trials Call Center, Ede 6717 RP, Netherlands
GSK Clinical Trials Call Center, Eindhoven 5623 EJ, Netherlands
GSK Clinical Trials Call Center, Den Haag 2512 VA, Netherlands
GSK Clinical Trials Call Center, Alkmaar 1815 JD, Netherlands
GSK Clinical Trials Call Center, Venlo 5912 BL, Netherlands
Additional Information
Starting date: September 2005
Last updated: November 7, 2007
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