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

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ClinicalTrials.gov Identifier: NCT00158873
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 16, 2008
Sponsor:
Information provided by:

Study Description
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated 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

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00158873


Locations
Netherlands
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov 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:
Propofol
Midazolam
Remifentanil
Lorazepam
Fentanyl
Morphine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
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
Anticonvulsants
Antiemetics
Autonomic Agents
Gastrointestinal Agents