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Plataforma canadiense de eficacia comparativa de cuidados críticos (CEPEC)

2 de noviembre de 2026 actualizado por: Université de Sherbrooke

Plataforma Canadiense de Efectividad Comparativa de Cuidados Críticos (e) d'Évaluación Clinique Comparée en Soins Critiques (CEPEC)

The Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en soins Critiques (CEPEC) is an international multi-centered randomized adaptive platform clinical trial. CEPEC will evaluate supportive care interventions that are used routinely in intensive care units throughout the world.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Many supportive therapies used daily in the ICU setting remain under-studied despite being resource-intensive. CEPEC aims to incorporate domains evaluating vasopressors and inotropes, nutrition, transfusions, sedation, correction of electrolyte deficits, sedation and analgesia, airway management, end-of-life care practices and other interventions.

Domains refer to categories of patient care for which interventions are being evaluated in a randomized controlled trial (RCT) within the platform.

VASOPRESSOR DOMAIN The investigators will investigate whether vasoactive medications should be used differently for different subgroups of patients who are in a state of cardiovascular shock (i.e. heterogeneity of treatment effects). Vasoactive medications are common in critically ill patients, and have considerable patient, hospital, and health system resource impact, but their use remains poorly supported by scientific evidence.

PLATELET DOMAIN Platelet transfusions are commonly prescribed to critically ill patients and have considerable patient, hospital, and health system resource impact, but remain poorly supported by scientific evidence. We propose to join a multicentre randomized clinical trial (T4P, ISRCTN79371664) addressing the optimal use of platelet transfusions for critically ill patients with thrombocytopenia in advance of invasive procedures. A multinational collaboration will ensure timely completion of this high-impact multicentre randomized clinical trial. The Canadian component of the T4P trial is embedded in the CEPEC platform as the Platelet Domain.

NUTRITION DOMAIN Most critically ill patients cannot eat normally and require a specialized method of feeding, called enteral nutrition. It is provided every hour around the clock. This differs from how we usually eat, with meals (boluses) divided over the day while we are awake. The goals of this study are to determine if a large study can be successfully done comparing nutrition given 3 times a day (boluses) compared to given in small amounts every hour (continuously).

INITIATIVES Initiatives are cross-cutting non-randomized studies nested within the platform that are relevant to all domains. Examples include a parallel observational study initiative, which aims to collect data about usual care and outcomes directly relevant to each domain. The goal is to describe the representativeness of domain results and to assess for protocol misalignment. Similarly, the living knowledge synthesis and health economics initiatives aim to generate meta-analyses and cost-effectiveness analyses alongside each trial conducted in the platform.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

5500

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.

Estudio Contacto

Ubicaciones de estudio

  • Canadá
    • New Brunswick
      • Moncton, New Brunswick, Canadá, E1C 2Z3
        • Reclutamiento
        • Centre hospitalier universitaire Dr-Georges-L.-Dumont
        • Contacto:
        • Investigador principal:
          • Rémi Leblanc
    • Ontario
      • Hamilton, Ontario, Canadá, L8L 2X2
        • Reclutamiento
        • Hamilton General Hospital
        • Contacto:
          • Lori Hand
          • Número de teléfono: 905-536-2777
          • Correo electrónico: handlori@hhsc.ca
        • Investigador principal:
          • Kimia Honarmand
      • Hamilton, Ontario, Canadá, L8V 1C3
        • Reclutamiento
        • Hamilton Health Sciences - Juravinski Hospital
        • Contacto:
        • Investigador principal:
          • Bram Rochwerg
      • Ottawa, Ontario, Canadá, K1H 8L6
        • Reclutamiento
        • The Ottawa Hospital
        • Contacto:
          • Irene Watpool
          • Número de teléfono: 613-737-8724
          • Correo electrónico: iwatpool@ohri.ca
        • Investigador principal:
          • Alexandre Tran
      • Scarborough Village, Ontario, Canadá, M1P 2V5
        • Reclutamiento
        • Scarborough Health Network
        • Contacto:
          • Joshua Craig
          • Número de teléfono: 416-438-2911
          • Correo electrónico: jcraig@shn.ca
        • Investigador principal:
          • Christopher Yarnell
      • St. Catharines, Ontario, Canadá, L2S 0A9
        • Reclutamiento
        • Niagara Health
        • Investigador principal:
          • Jennifer Tsang
        • Contacto:
      • Toronto, Ontario, Canadá, M4N 3M5
        • Reclutamiento
        • Sunnybrook Health Sciences Centre
        • Contacto:
        • Investigador principal:
          • Neill Adhikari
    • Quebec
      • Longueuil, Quebec, Canadá, J4V 2H1
        • Reclutamiento
        • Hôpital Charles-Le Moyne
        • Contacto:
        • Investigador principal:
          • Dany Burke
      • Montreal, Quebec, Canadá, H2X 0C1
        • Reclutamiento
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Contacto:
        • Investigador principal:
          • Francois-Martin Carrier
      • Montreal, Quebec, Canadá, H4J 1C5
        • Reclutamiento
        • CIUSSS NIM - Hôpital du Sacré-Coeur-de-Montréal
        • Contacto:
        • Investigador principal:
          • Yiorgos Alexandros Cavayas
      • Sherbrooke, Quebec, Canadá, J1H 5N4
        • Reclutamiento
        • CIUSSS de l'Estrie - CHUS
        • Contacto:
        • Investigador principal:
          • Francois Lamontagne
        • Contacto:
  • Nueva Zelanda
      • Auckland, Nueva Zelanda
        • Aún no reclutando
        • Auckland City Hospital
  • Reino Unido
      • London, Reino Unido
        • Aún no reclutando
        • Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined)

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

VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.

Inclusion criteria:

  1. Ongoing vasopressor infusion to treat hypotension, or would be used to treat clinician-defined hypotension as part of usual care;
  2. MAP <75 mmHg at any point;
  3. Patient expected to be in the ICU for >24 hours.

Exclusion criteria:

  1. Treating team does not have equipoise for at least two contiguous MAP target ranges in the CEPEC Vasopressor Domain;
  2. Acute traumatic brain injury (within 7 days or ongoing active treatment for elevated intracranial pressure);
  3. Acute subarachnoid hemorrhage (within 21 days);
  4. Acute spinal cord injury (within 7 days of injury or ongoing vasopressor therapy for suspected spinal cord ischemia);
  5. Lung, heart, liver, kidney transplant recipient (within 7 days);
  6. Patient expected to become an organ donor (Donor Neurologic Death - DND or Donation After Circulatory Death - DCD);
  7. More than 24 hours since meeting inclusion criteria in the ICU;
  8. Previously randomized into the CEPEC Vasopressor Domain or a confounding trial.

PLATELET DOMAIN

Inclusion criteria:

  1. Adult patients (age ≥18 years) admitted to the ICU;
  2. Latest platelet count in this hospital admission <50×109/L;
  3. Planned to undergo a specified low-moderate bleeding risk invasive procedure.

Exclusion criteria:

  1. Ongoing major hemorrhage requiring blood products and/or surgical/ radiological intervention;
  2. Intracranial hemorrhage within prior 72 hours;
  3. Contraindications to platelet transfusion (e.g. thrombotic microangiopathies, heparin-induced thrombocytopenia, recent history of immune thrombocytopaenia, congenital platelet function defects);
  4. Known advance decision of refusing blood/blood component transfusions;
  5. Acute promyelocytic leukemia (APML);
  6. Death perceived as imminent or admission for palliation;
  7. Previously randomized into the CEPEC Platelet Domain or the T4P Trial;
  8. Fulfilled all the inclusion criteria and none of the exclusion criteria ≥72 hours.

NUTRITION DOMAIN

Inclusion criteria:

  1. Patient of ≥18 years of age;
  2. Patient is invasively mechanically ventilated (including endotracheal tube or tracheostomy);
  3. Orogastric/nasogastric tube in place; or have an in dwelling percutaneous gastric tube (with confirmed placement);
  4. Treating team has started or has the intention of providing enteral nutrition.

Exclusion criteria:

  1. Patient who has had gastrointestinal (GI) surgery in the last 3 months and deemed not ready to receive possible bolus nutrition;
  2. Bowel obstruction or ischemia; active;
  3. Has a post-pyloric small bowel feeding tube;
  4. Active GI bleeding;
  5. Patient who is chronically receiving enteral nutrition.

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
Otro: Vasopressor

Participants will receive vasopressor(s) and their mean arterial pressure will be titrated according to the group they are randomized to (group 1: 56-60 mmHg; group 2: 61-65 mmHg; group 3: 66-70 mmHg; group 4: 71-75 mmHg). Physicians will have the liberty of restricting the randomization to at least 2 contiguous ranges.
Droga: 1- Vasopressor - Mean arterial pressure 56-60

Vasopressor(s) will be titrated according to 56-60 range.

Droga: 2- Vasopressor - Mean arterial pressure 61-65

Vasopressor(s) will be titrated according to 61-65 range.

Droga: 3- Vasopressor - Mean arterial pressure 66-70

Vasopressor(s) will be titrated according to 66-70 range.

Droga: 4- Vasopressor - Mean arterial pressure 71-75

Vasopressor(s) will be titrated according to 71-75 range.
Otro: Platelet

Thrombocytopenic intensive care unit (ICU) patients (platelet count <50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.
Otro: 1- Platelet less than 10 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 10 x 109/L at the time of the planned procedure.

Otro: 2- Platelet less than 20 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 20 x 109/L at the time of the planned procedure.

Otro: 3- Platelet less than 30 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 30 x 109/L at the time of the planned procedure.

Otro: 4- Platelet less than 40 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 40 x 109/L at the time of the planned procedure.

Otro: 5- Platelet less than 50 x 109/L

Once randomized, the participant will receive a platelet transfusion if their most recent platelet count is less than 50 x 109/L at the time of the planned procedure.
Otro: Nutrition

The intervention is bolus feeding (given 3 times a day to meet nutritional targets) with formula type left to the discretion of the precribing team. With 2 hours between each "feed".

The control is continuous feeding (over 24-hour period) with formula type left to the discretion of the prescribing team, which is the current standard of care.
Otro: Enteral nutrition - Boluses

Given 3 times a day.

Otro: Enteral nutrition - Continuous

Given over 24-hour period

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Platelet Domain - All cause mortality
Periodo de tiempo: 90 days

90-day all-cause mortality
90 days
Nutrition Domain - Recruitment rate
Periodo de tiempo: 1 year

Recruitment rate of 2 patients per site per month.
1 year
Vasopressor Domain - 30-day ordinal outcome
Periodo de tiempo: At hospital discharge up to day 30

Incorporate mortality, persistent organ dysfunction (POD) in the ICU, hospitalization, discharge to a location providing more health services than at the patient's baseline residence, and discharge to baseline level residence.
At hospital discharge up to day 30

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dominio de plaquetas: mortalidad al alta del hospital
Periodo de tiempo: Alta del hospital
Alta del hospital
Dominio de plaquetas: mortalidad al año
Periodo de tiempo: 1 año después de la aleatorización
1 año después de la aleatorización
Dominio de plaquetas: resultados de sangrado en el hospital (hemorragias mayores y fatales)
Periodo de tiempo: Durante la hospitalización
Durante la hospitalización
Dominio de plaquetas: días vivos y en casa en el día 90
Periodo de tiempo: 90 días
90 días
Platelet Domain - Transfusion complications
Periodo de tiempo: During hospitalization

Transfusion-associated circulatory overload, transfusion-related acute lung injury, infections, anaphylaxis
During hospitalization
Platelet Domain - Health-related quality of life
Periodo de tiempo: 90 days

Evaluated using EQ-5D-5L questionnaire
90 days
Nutrition Domain - Diarrhea
Periodo de tiempo: 24 hours

Defined by the World Health Organization (WHO) definition (3 or greater liquids stools/24 hours)
24 hours
Nutition Domain - Percentage of target nutritional intake
Periodo de tiempo: Over the course of the ICU stay up to day 30

>80%
Over the course of the ICU stay up to day 30
Nutrition Domain - Vomiting
Periodo de tiempo: During ICU stay up to day 30

Vomiting 2 or more times in a 24-hour period
During ICU stay up to day 30
Vasopressor, Platelet and Nutrition Domains - Each component of the 30-day ordinal primary outcome
Periodo de tiempo: At hospital discharge up to day 30
  1. Mortality
  2. POD in the ICU
  3. Hospitalization
  4. Discharge to a location providing more health services than at the patient's baseline residence
  5. Discharge to baseline level residence.
At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Days free of POD to day 30
Periodo de tiempo: At hospital discharge up to day 30

POD is defined as a vasopressor infusion, invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen (delivered via nasal prongs or cannula by a specialized device, with a FiO2 ≥0.4 and at a flow rate ≥30L/min), or new renal replacement therapy.
At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Hospital days up to day 30
Periodo de tiempo: Up to day 30
Up to day 30
Vasopressor, Platelet and Nutrition Domains - ICU days to day 30
Periodo de tiempo: Up to day 30
Up to day 30
Platelet Domain - Number of days without POD in the ICU
Periodo de tiempo: Up to day 90
Up to day 90

Colaboradores e Investigadores

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

Patrocinador

Université de Sherbrooke

Colaboradores

Hamilton Health Sciences Corporation

Investigadores

  • Investigador principal: Francois Lamontagne, MD, MSc, Université de Sherbrooke
  • Investigador principal: Neill Adhikari, MDCM, MSc, Sunnybrook Research Institute

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

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 (Actual)

23 de marzo de 2025

Finalización primaria (Estimado)

31 de diciembre de 2029

Finalización del estudio (Estimado)

30 de junio de 2030

Fechas de registro del estudio

Enviado por primera vez

10 de septiembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

17 de septiembre de 2024

Publicado por primera vez (Actual)

20 de septiembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de noviembre de 2026

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

2 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • MP-31-2025-5600

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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