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

25 maj 2017 uppdaterad av: GlaxoSmithKline

A Randomized, Open Label, Multicentre Study to Compare the Pharmaco-economic Implications of an Analgesia Based Regimen With Remifentanil and a Conventional Sedation Based Regimen Using Propofol in Medical and Post-surgical ICU Subjects Requiring Mechanical Ventilation for at Least 2 Days.

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

39

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Italien
    • Calabria
      • Catanzaro, Calabria, Italien, 88100
        • GSK Investigational Site
    • Campania
      • Napoli, Campania, Italien, 80131
        • GSK Investigational Site
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italien, 44100
        • GSK Investigational Site
    • Friuli-Venezia-Giulia
      • Udine, Friuli-Venezia-Giulia, Italien, 33100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italien, 00161
        • GSK Investigational Site
    • Sicilia
      • Palermo, Sicilia, Italien, 90127
        • GSK Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Propofol
Propofol infusion
Läkemedel: Propofol
conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical
Experimentell: Remifentanil
remifentanil
Läkemedel: Remifentanil
analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
Tidsram: Up to 38 days (912 hours)
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)
Tidsram: Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation.
Up to 38 days (912 hours)
Duration of Time on Mechanical Ventilation (Per-Protocol Population)
Tidsram: Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation
Up to 38 days (912 hours)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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)
Tidsram: Up to 38 days (912 hours)
Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.
Up to 38 days (912 hours)
Duration of Extubation
Tidsram: up to 38 days (912 hours)
Duration of extubation was measured.
up to 38 days (912 hours)
Duration of Weaning
Tidsram: up to 38 days (912 hours)
Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.
up to 38 days (912 hours)
Duration of Remifentanil Infusion (ITT Population)
Tidsram: Up to 10 days (240 hours)
Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Up to 10 days (240 hours)
Duration of Propofol Infusion (ITT Population)
Tidsram: up to 10 days (240 hours)
Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
up to 10 days (240 hours)
Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)
Tidsram: up to 10 days (240 hours)
Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
up to 10 days (240 hours)
Dose of Remifentanil Administered - Continuous Infusion
Tidsram: Up to 10 days
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Up to 10 days
Doses of Sufentanil and Fentanil Administered - Continuous Infusion
Tidsram: up to 10 days
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
up to 10 days
Dose of Propofol Administered - Continuous Infusion
Tidsram: Up to 10 days
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Up to 10 days
Dose of Morphine Administered - Continuous Infusion
Tidsram: up to 10 days
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
up to 10 days
Total Dose of Propofol Administered - Bolus
Tidsram: Up to 10 days
Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Up to 10 days
Total Dose of Fentanil Administered - Bolus
Tidsram: Up to 10 days
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Up to 10 days
Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale
Tidsram: Up to 38 Days
Data from participants in the study for which the Sedation-Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Up to 38 Days
Sedation-Agitation From Screening Through the End of Study
Tidsram: Up to 38 days
"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Up to 38 days
Sedation-Agitation for Day 7
Tidsram: Day 7
"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Day 7
Sedation-Agitation From Day 8 to Day 10
Tidsram: Days 8, 9, and 10
"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Days 8, 9, and 10
Number of Participants Analyzed for BIS (Bispectral Index Scale)
Tidsram: Up to 38 days
Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Up to 38 days
Bispectral Index (BIS)
Tidsram: Screening through End of Study, up to 38 days
The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Screening through End of Study, up to 38 days
Bispectral Index (BIS) for Day 5
Tidsram: Day 5
The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Day 5
Bispectral Index (BIS) for Extubation Period and Post-Extubation Period
Tidsram: up to 38 days
The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
up to 38 days
Pain Intensity (PI)
Tidsram: Up to 38 days
"Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Up to 38 days
Pain Intensity From Day 8 to Day 10
Tidsram: Days 8, 9, and 10
"Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Days 8, 9, and 10

Samarbetspartners och utredare

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Sponsor

GlaxoSmithKline

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2007

Primärt slutförande (Faktisk)

1 augusti 2008

Avslutad studie (Faktisk)

1 september 2008

Studieregistreringsdatum

Först inskickad

15 februari 2007

Först inskickad som uppfyllde QC-kriterierna

15 februari 2007

Första postat (Uppskatta)

19 februari 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 maj 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 maj 2017

Senast verifierad

1 maj 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 108701

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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