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

25 de mayo de 2017 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

39

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Propofol
Infusión de propofol
Droga: Propofol
conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical
Experimental: Remifentanil
remifentanil
Droga: Remifentanil
analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation
Up to 38 days (912 hours)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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)
Periodo de tiempo: 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
Periodo de tiempo: up to 38 days (912 hours)
Duration of extubation was measured.
up to 38 days (912 hours)
Duration of Weaning
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 2007

Finalización primaria (Actual)

1 de agosto de 2008

Finalización del estudio (Actual)

1 de septiembre de 2008

Fechas de registro del estudio

Enviado por primera vez

15 de febrero de 2007

Primero enviado que cumplió con los criterios de control de calidad

15 de febrero de 2007

Publicado por primera vez (Estimar)

19 de febrero de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de mayo de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

25 de mayo de 2017

Última verificación

1 de mayo de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 108701

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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