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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00158873

Purpose

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	Intervention	Phase
Sedation	Drug: midazolam Drug: lorazepam Drug: fentanyl Drug: morphine Drug: remifentanil Drug: propofol	Phase IV

Drug Information available for: Fentanyl Citrate Fentanyl Midazolam Midazolam hydrochloride Midazolam maleate Propofol Remifentanil Remifentanil hydrochloride Lorazepam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Health Outcome: Duration of time on mechanical ventilation

Secondary Outcome Measures:

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

Estimated Enrollment:	224
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158873

Locations

Netherlands
GSK Investigational Site
ALKMAAR, Netherlands, 1815 JD
GSK Investigational Site
DEN HAAG, Netherlands, 2512 VA
GSK Investigational Site
EINDHOVEN, Netherlands, 5623 EJ
GSK Investigational Site
DORDRECHT, Netherlands, 3318 AT
GSK Investigational Site
EDE, Netherlands, 6716 RP
GSK Investigational Site
HAARLEM, Netherlands, 2035 RC
GSK Investigational Site
APELDOORN, Netherlands, 7334 DZ
GSK Investigational Site
VENLO, Netherlands, 5912 BL
GSK Investigational Site
TIEL, Netherlands, 4002 WP
GSK Investigational Site
AMSTERDAM, Netherlands, 1081 HV
GSK Investigational Site
ZWOLLE, Netherlands, 8011 JW
GSK Investigational Site
HELMOND, Netherlands, 5707 HA
GSK Investigational Site
HENGELO, Netherlands, 7555 DL
GSK Investigational Site
DEN BOSCH, Netherlands, 5211 RW
GSK Investigational Site
ROTTERDAM, Netherlands, 3015 GJ

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	101653
Study First Received:	September 8, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00158873
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:

ICU mechanical ventilation analgesia sedation

Study placed in the following topic categories:

Lorazepam
Morphine
Fentanyl

Remifentanil
Propofol
Midazolam

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Antiemetics
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Analgesics, Opioid
Anesthetics, Intravenous

Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Autonomic Agents
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009