Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)

NCT00436345 | Terminated Phase 3 Results

• 1 other identifier: 108701
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 6

Brief Summary

This study will be a multicentre randomized, open-label, phase IIIb study. This study will evaluate two different techniques of sedation: an analgesia based regimen with remifentanil versus a conventional sedation based regimen using propofol in subjects that require mechanical ventilation for at least 2 days in the ICU. The conventional sedation based regimen will consist of propofol combined with an opioid according to routine clinical practice (morphine, fentanyl, sufentanil or other as required) . The analgesia based regimen will consist of remifentanil, with propofol added on if required.

Conditions

Analgesia

Keywords

analgesia; Mechanical ventilation; pharmaco-economic; ICU

Outcome Measures

Primary Outcomes (3)

• Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)

  Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).

  Up to 38 days (912 hours)

• Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)

  Time from start of mechanical ventilation until actual extubation.

  Up to 38 days (912 hours)

• Duration of Time on Mechanical Ventilation (Per-Protocol Population)

  Time from start of mechanical ventilation until actual extubation

  Up to 38 days (912 hours)

Secondary Outcomes (22)

• Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator's Decision)

  Up to 38 days (912 hours)

• Duration of Extubation

  up to 38 days (912 hours)

• Duration of Weaning

  up to 38 days (912 hours)

• Duration of Remifentanil Infusion (ITT Population)

  Up to 10 days (240 hours)

• Duration of Propofol Infusion (ITT Population)

  up to 10 days (240 hours)

Study Arms (2)

Remifentanil

EXPERIMENTAL

remifentanil

Drug: Remifentanil

Propofol

ACTIVE COMPARATOR

Propofol infusion

Drug: Propofol

Interventions

Remifentanil DRUG

analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation

Remifentanil

Propofol DRUG

conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical

Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
• Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
• Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid.

You may not qualify if:

• Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
• Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided
• Concurrent medications:
• Requires or is likely to require neuromuscular blocking agents by continuous infusion to facilitate mechanical ventilation
• Has or is likely to receive an epidural block during the treatment period

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Catanzaro, Calabria, 88100, Italy

Location

GSK Investigational Site

Napoli, Campania, 80131, Italy

Location

GSK Investigational Site

Ferrara, Emilia-Romagna, 44100, Italy

Location

GSK Investigational Site

Udine, Friuli Venezia Giulia, 33100, Italy

Location

GSK Investigational Site

Rome, Lazio, 00161, Italy

Location

GSK Investigational Site

Palermo, Sicily, 90127, Italy

Location

MeSH Terms

Conditions

Agnosia

Interventions

Remifentanil; Propofol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: November 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 30, 2017
• Results First Posted: May 18, 2010

Record last verified: 2017-05

Locations

IT (6)