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

NCT ID: NCT00158873

Last Updated: 2008-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sedation

Keywords

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ICU mechanical ventilation analgesia sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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midazolam

Intervention Type DRUG

lorazepam

Intervention Type DRUG

fentanyl

Intervention Type DRUG

morphine

Intervention Type DRUG

remifentanil

Intervention Type DRUG

propofol

Intervention Type DRUG

Other Intervention Names

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midazolam lorazepam fentanyl morphine remifentanil

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

's-Hertogenbosch, , Netherlands

Site Status

GSK Investigational Site

Alkmaar, , Netherlands

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Apeldoorn, , Netherlands

Site Status

GSK Investigational Site

Dordrecht, , Netherlands

Site Status

GSK Investigational Site

Ede, , Netherlands

Site Status

GSK Investigational Site

Eindhoven, , Netherlands

Site Status

GSK Investigational Site

Haarlem, , Netherlands

Site Status

GSK Investigational Site

Helmond, , Netherlands

Site Status

GSK Investigational Site

Hengelo, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

The Hague, , Netherlands

Site Status

GSK Investigational Site

Tiel, , Netherlands

Site Status

GSK Investigational Site

Venlo, , Netherlands

Site Status

GSK Investigational Site

Zwolle, , Netherlands

Site Status

Countries

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Netherlands

References

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Al MJ, Hakkaart L, Tan SS, Bakker J. Cost-consequence analysis of remifentanil-based analgo-sedation vs. conventional analgesia and sedation for patients on mechanical ventilation in the Netherlands. Crit Care. 2010;14(6):R195. doi: 10.1186/cc9313. Epub 2010 Nov 1.

Reference Type DERIVED
PMID: 21040558 (View on PubMed)

Other Identifiers

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101653

Identifier Type: -

Identifier Source: org_study_id