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Canadees platform voor vergelijkende effectiviteit voor kritieke zorg (CEPEC)

2 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

5500

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 2Z3
        • Werving
        • Centre hospitalier universitaire Dr-Georges-L.-Dumont
        • Contact:
        • Hoofdonderzoeker:
          • Rémi Leblanc
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Werving
        • Hamilton General Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Kimia Honarmand
      • Hamilton, Ontario, Canada, L8V 1C3
        • Werving
        • Hamilton Health Sciences - Juravinski Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Bram Rochwerg
      • Ottawa, Ontario, Canada, K1H 8L6
        • Werving
        • The Ottawa Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Alexandre Tran
      • Scarborough Village, Ontario, Canada, M1P 2V5
        • Werving
        • Scarborough Health Network
        • Contact:
          • Joshua Craig
          • Telefoonnummer: 416-438-2911
          • E-mail: jcraig@shn.ca
        • Hoofdonderzoeker:
          • Christopher Yarnell
      • St. Catharines, Ontario, Canada, L2S 0A9
      • Toronto, Ontario, Canada, M4N 3M5
        • Werving
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Hoofdonderzoeker:
          • Neill Adhikari
    • Quebec
      • Longueuil, Quebec, Canada, J4V 2H1
      • Montreal, Quebec, Canada, H2X 0C1
        • Werving
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Contact:
        • Hoofdonderzoeker:
          • Francois-Martin Carrier
      • Montreal, Quebec, Canada, H4J 1C5
        • Werving
        • CIUSSS NIM - Hôpital du Sacré-Coeur-de-Montréal
        • Contact:
        • Hoofdonderzoeker:
          • Yiorgos Alexandros Cavayas
      • Sherbrooke, Quebec, Canada, J1H 5N4
  • Nieuw-Zeeland
      • Auckland, Nieuw-Zeeland
        • Nog niet aan het werven
        • Auckland City Hospital
  • Verenigd Koninkrijk
      • London, Verenigd Koninkrijk
        • Nog niet aan het werven
        • Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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.
Geneesmiddel: 1- Vasopressor - Mean arterial pressure 56-60

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

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

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

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

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

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

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

Ander: 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.

Ander: 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.

Ander: 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.

Ander: 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.
Ander: 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.
Ander: Enteral nutrition - Boluses

Given 3 times a day.

Ander: Enteral nutrition - Continuous

Given over 24-hour period

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Platelet Domain - All cause mortality
Tijdsspanne: 90 days

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

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Bloedplaatjesdomein - sterfte bij ontslag uit het ziekenhuis
Tijdsspanne: Ontslag uit het ziekenhuis
Ontslag uit het ziekenhuis
Bloedplaatjesdomein - sterfte op 1 jaar
Tijdsspanne: 1 jaar na randomisatie
1 jaar na randomisatie
Bloedplaatjesdomein - Bleeding -resultaten in het ziekenhuis (grote en fatale bloedingen)
Tijdsspanne: Tijdens ziekenhuisopname
Tijdens ziekenhuisopname
Bloedplaatjesdomein - Dagen levend en thuis op dag 90
Tijdsspanne: 90 dagen
90 dagen
Platelet Domain - Transfusion complications
Tijdsspanne: During hospitalization

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Université de Sherbrooke

Medewerkers

Hamilton Health Sciences Corporation

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 maart 2025

Primaire voltooiing (Geschat)

31 december 2029

Studie voltooiing (Geschat)

30 juni 2030

Studieregistratiedata

Eerst ingediend

10 september 2024

Eerst ingediend dat voldeed aan de QC-criteria

17 september 2024

Eerst geplaatst (Werkelijk)

20 september 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • MP-31-2025-5600

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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