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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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 Investigational Site, Alkmaar 1815 JD, Netherlands

GSK Investigational Site, Amsterdam 1081 HV, Netherlands

GSK Investigational Site, Apeldoorn 7334 DZ, Netherlands

GSK Investigational Site, Den Bosch 5211 RW, Netherlands

GSK Investigational Site, Den Haag 2512 VA, 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, Tiel 4002 WP, Netherlands

GSK Investigational Site, Venlo 5912 BL, Netherlands

GSK Investigational Site, Zwolle 8011 JW, Netherlands

Additional Information

Starting date: September 2004
Last updated: October 15, 2008

Page last updated: August 23, 2015

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