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Plataforma Canadense de Eficácia Comparativa em Cuidados Intensivos (CEPEC)

2 de novembro de 2026 atualizado por: Université de Sherbrooke

Plataforma Canadense de Eficácia Comparativa em Cuidados Críticos (e) de Avaliação Clinique Comparada em 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

5500

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Canadá
    • New Brunswick
      • Moncton, New Brunswick, Canadá, E1C 2Z3
        • Recrutamento
        • Centre hospitalier universitaire Dr-Georges-L.-Dumont
        • Contato:
        • Investigador principal:
          • Rémi Leblanc
    • Ontario
      • Hamilton, Ontario, Canadá, L8L 2X2
        • Recrutamento
        • Hamilton General Hospital
        • Contato:
        • Investigador principal:
          • Kimia Honarmand
      • Hamilton, Ontario, Canadá, L8V 1C3
        • Recrutamento
        • Hamilton Health Sciences - Juravinski Hospital
        • Contato:
        • Investigador principal:
          • Bram Rochwerg
      • Ottawa, Ontario, Canadá, K1H 8L6
        • Recrutamento
        • The Ottawa Hospital
        • Contato:
        • Investigador principal:
          • Alexandre Tran
      • Scarborough Village, Ontario, Canadá, M1P 2V5
        • Recrutamento
        • Scarborough Health Network
        • Contato:
          • Joshua Craig
          • Número de telefone: 416-438-2911
          • E-mail: jcraig@shn.ca
        • Investigador principal:
          • Christopher Yarnell
      • St. Catharines, Ontario, Canadá, L2S 0A9
        • Recrutamento
        • Niagara Health
        • Investigador principal:
          • Jennifer Tsang
        • Contato:
      • Toronto, Ontario, Canadá, M4N 3M5
        • Recrutamento
        • Sunnybrook Health Sciences Centre
        • Contato:
        • Investigador principal:
          • Neill Adhikari
    • Quebec
      • Longueuil, Quebec, Canadá, J4V 2H1
        • Recrutamento
        • Hôpital Charles-Le Moyne
        • Contato:
        • Investigador principal:
          • Dany Burke
      • Montreal, Quebec, Canadá, H2X 0C1
        • Recrutamento
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Contato:
        • Investigador principal:
          • Francois-Martin Carrier
      • Montreal, Quebec, Canadá, H4J 1C5
        • Recrutamento
        • CIUSSS NIM - Hôpital du Sacré-Coeur-de-Montréal
        • Contato:
        • Investigador principal:
          • Yiorgos Alexandros Cavayas
      • Sherbrooke, Quebec, Canadá, J1H 5N4
        • Recrutamento
        • CIUSSS de l'Estrie - CHUS
        • Contato:
        • Investigador principal:
          • Francois Lamontagne
        • Contato:
  • Nova Zelândia
      • Auckland, Nova Zelândia
        • Ainda não está recrutando
        • Auckland City Hospital
  • Reino Unido
      • London, Reino Unido
        • Ainda não está recrutando
        • Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined)

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: 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.
Medicamento: 1- Vasopressor - Mean arterial pressure 56-60

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

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

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

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

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

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

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

Outro: 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.

Outro: 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.

Outro: 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.

Outro: 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.
Outro: 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.
Outro: Enteral nutrition - Boluses

Given 3 times a day.

Outro: Enteral nutrition - Continuous

Given over 24-hour period

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Platelet Domain - All cause mortality
Prazo: 90 days

90-day all-cause mortality
90 days
Nutrition Domain - Recruitment rate
Prazo: 1 year

Recruitment rate of 2 patients per site per month.
1 year
Vasopressor Domain - 30-day ordinal outcome
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Domínio de plaquetas - mortalidade na alta do hospital
Prazo: Alta do hospital
Alta do hospital
Domínio de plaquetas - mortalidade em 1 ano
Prazo: 1 ano após a randomização
1 ano após a randomização
Domínio de plaquetas - Resultados de sangramento no hospital (sangramentos principais e fatais)
Prazo: Durante a hospitalização
Durante a hospitalização
Domínio de plaquetas - Dias vivos e em casa no dia 90
Prazo: 90 dias
90 dias
Platelet Domain - Transfusion complications
Prazo: During hospitalization

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

Evaluated using EQ-5D-5L questionnaire
90 days
Nutrition Domain - Diarrhea
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to day 30
Up to day 30
Vasopressor, Platelet and Nutrition Domains - ICU days to day 30
Prazo: Up to day 30
Up to day 30
Platelet Domain - Number of days without POD in the ICU
Prazo: Up to day 90
Up to day 90

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de março de 2025

Conclusão Primária (Estimado)

31 de dezembro de 2029

Conclusão do estudo (Estimado)

30 de junho de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

10 de setembro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de setembro de 2024

Primeira postagem (Real)

20 de setembro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • MP-31-2025-5600

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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