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

GlaxoSmithKline224 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Conditions

Sedation

Interventions

midazolamDRUG

lorazepamDRUG

fentanylDRUG

morphineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

GSK Investigational Site

's-Hertogenbosch, Netherlands

GSK Investigational Site

Alkmaar, Netherlands

GSK Investigational Site

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Health Outcome: Duration of time on mechanical ventilation

Secondary Outcomes

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

Data from ClinicalTrials.gov

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