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NCT00158873 Clinical Trial

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

Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00158873
Other study ID # 101653
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2005
Last updated October 15, 2008
Start date September 2004

Study information
Verified date October 2008
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 224
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• midazolam

• lorazepam

• fentanyl

• morphine

• remifentanil

• propofol

Locations
Country Name City State
Netherlands GSK Investigational Site Alkmaar
Netherlands GSK Investigational Site Amsterdam
Netherlands GSK Investigational Site Apeldoorn
Netherlands GSK Investigational Site Den Bosch
Netherlands GSK Investigational Site Den Haag
Netherlands GSK Investigational Site Dordrecht
Netherlands GSK Investigational Site EDE
Netherlands GSK Investigational Site Eindhoven
Netherlands GSK Investigational Site Haarlem
Netherlands GSK Investigational Site Helmond
Netherlands GSK Investigational Site Hengelo
Netherlands GSK Investigational Site Rotterdam
Netherlands GSK Investigational Site Tiel
Netherlands GSK Investigational Site Venlo
Netherlands GSK Investigational Site Zwolle

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Health Outcome: Duration of time on mechanical ventilation
Secondary 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
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