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Plateforme canadienne d'efficacité comparative des soins intensifs (CEPEC)

2 novembre 2026 mis à jour par: Université de Sherbrooke

Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

5500

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: 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.
Médicament: 1- Vasopressor - Mean arterial pressure 56-60

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

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

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

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

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

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

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

Autre: 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.

Autre: 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.

Autre: 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.

Autre: 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.
Autre: 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.
Autre: Enteral nutrition - Boluses

Given 3 times a day.

Autre: Enteral nutrition - Continuous

Given over 24-hour period

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Platelet Domain - All cause mortality
Délai: 90 days

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

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Domaine plaquettaire - Mortalité à la sortie de l'hôpital
Délai: Libération de l'hôpital
Libération de l'hôpital
Domaine des plaquettes - Mortalité à 1 an
Délai: 1 an après la randomisation
1 an après la randomisation
Domaine plaquette - Résultats de saignement à l'hôpital (saignements majeurs et mortels)
Délai: Pendant l'hospitalisation
Pendant l'hospitalisation
Domaine des plaquettes - jours vivants et à la maison au jour 90
Délai: 90 jours
90 jours
Platelet Domain - Transfusion complications
Délai: During hospitalization

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Université de Sherbrooke

Collaborateurs

Hamilton Health Sciences Corporation

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

23 mars 2025

Achèvement primaire (Estimé)

31 décembre 2029

Achèvement de l'étude (Estimé)

30 juin 2030

Dates d'inscription aux études

Première soumission

10 septembre 2024

Première soumission répondant aux critères de contrôle qualité

17 septembre 2024

Première publication (Réel)

20 septembre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • MP-31-2025-5600

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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