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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00158873
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 16, 2008
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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.

Condition or disease Intervention/treatment Phase
Sedation Drug: midazolam Drug: lorazepam Drug: fentanyl Drug: morphine Drug: remifentanil Drug: propofol Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2004

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: midazolam
  • Drug: lorazepam
  • Drug: fentanyl
  • Drug: morphine
  • Drug: remifentanil
  • Drug: propofol
    Other Names:
    • midazolam
    • lorazepam
    • fentanyl
    • morphine
    • remifentanil

Primary Outcome Measures :
  1. Health Outcome: Duration of time on mechanical ventilation

Secondary Outcome Measures :
  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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00158873

GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Amsterdam, Netherlands, 1081 HV
GSK Investigational Site
Apeldoorn, Netherlands, 7334 DZ
GSK Investigational Site
Den Bosch, Netherlands, 5211 RW
GSK Investigational Site
Den Haag, Netherlands, 2512 VA
GSK Investigational Site
Dordrecht, Netherlands, 3318 AT
GSK Investigational Site
EDE, Netherlands, 6716 RP
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Haarlem, Netherlands, 2035 RC
GSK Investigational Site
Helmond, Netherlands, 5707 HA
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
GSK Investigational Site
Rotterdam, Netherlands, 3015 GJ
GSK Investigational Site
Tiel, Netherlands, 4002 WP
GSK Investigational Site
Venlo, Netherlands, 5912 BL
GSK Investigational Site
Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Study Director, GSK Identifier: NCT00158873     History of Changes
Other Study ID Numbers: 101653
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 16, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
ICU mechanical ventilation analgesia sedation

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Gastrointestinal Agents