Canadian Critical Care Comparative Effectiveness Platform

NCT06605144 | Recruiting Phase 3 DMC

• 1 other identifier: MP-31-2025-5600
• Study Type: interventional
• Target: 5,500
• Locations: 3 countries
• Sites: 9

Brief Summary

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.

Conditions

Vasopressor; Platelet; Intensive Care Unit ICU; Nutrition

Keywords

ICU; Adaptive platform trial; Vasopressor; Platelet; Enteral nutrition

Outcome Measures

Primary Outcomes (3)

• Vasopressor Domain - Composite endpoint

  Incorporate mortality, persistent organ dysfunction (POD) in the intensive care unit (ICU), days in hospital, and disposition at hospital discharge.

  At hospital discharge up to day 30

• Platelet Domain - All cause mortality

  90-day all-cause mortality

  90 days

• Nutrition Domain - Recruitment rate

  Recruitment rate of 2 patients per site per month.

  1 year

Secondary Outcomes (15)

• Vasopressor, Platelet and Nutrition Domains - Mortality

  At hospital discharge up to day 30

• Vasopressor, Platelet and Nutrition Domains - Persistent organ dysfunction (POD) in the ICU

  At hospital discharge up to day 30

• Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU

  Up to day 30

• Vasopressor, Platelet and Nutrition Domains - Disposition at hospital discharge

  At hospital discharge up to day 30

• Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU

  At hospital discharge up to day 30

Study Arms (3)

Vasopressor

OTHER

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

Drug: 1- Vasopressor - Mean arterial pressure 56-60; Drug: 2- Vasopressor - Mean arterial pressure 61-65; Drug: 3- Vasopressor - Mean arterial pressure 66-70; Drug: 4- Vasopressor - Mean arterial pressure 71-75

Platelet

OTHER

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.

Other: 1- Platelet less than 10 x 109/L; Other: 2- Platelet less than 20 x 109/L; Other: 3- Platelet less than 30 x 109/L; Other: 4- Platelet less than 40 x 109/L; Other: 5- Platelet less than 50 x 109/L

Nutrition

OTHER

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.

Other: Enteral nutrition - Boluses; Other: Enteral nutrition - Continuous

Interventions

1- Vasopressor - Mean arterial pressure 56-60 DRUG

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

Vasopressor

2- Vasopressor - Mean arterial pressure 61-65 DRUG

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

Vasopressor

3- Vasopressor - Mean arterial pressure 66-70 DRUG

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

Vasopressor

4- Vasopressor - Mean arterial pressure 71-75 DRUG

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

Vasopressor

1- Platelet less than 10 x 109/L OTHER

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.

Platelet

2- Platelet less than 20 x 109/L OTHER

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.

Platelet

3- Platelet less than 30 x 109/L OTHER

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.

Platelet

4- Platelet less than 40 x 109/L OTHER

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.

Platelet

5- Platelet less than 50 x 109/L OTHER

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.

Platelet

Enteral nutrition - Boluses OTHER

Given 3 times a day.

Nutrition

Enteral nutrition - Continuous OTHER

Given over 24-hour period

Nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Treating team does not have equipoise for at least two contiguous MAP target ranges in the CEPEC Vasopressor Domain;
• Acute traumatic brain injury (within 7 days or ongoing active treatment for elevated intracranial pressure);
• Acute subarachnoid hemorrhage (within 21 days);
• Acute spinal cord injury (within 7 days of injury or ongoing vasopressor therapy for suspected spinal cord ischemia);
• Lung, heart, liver, kidney transplant recipient (within 7 days);
• Patient expected to become an organ donor (Donor Neurologic Death - DND or Donation After Circulatory Death - DCD);
• Previously randomized into the CEPEC Vasopressor Domain or a confounding trial.
• PLATELET DOMAIN
• Adult patients (age ≥18 years) admitted to the ICU;
• Latest platelet count in this hospital admission \<50×109/L;
• Planned to undergo a specified low-moderate bleeding risk invasive procedure.
• Ongoing major hemorrhage requiring blood products and/or surgical/ radiological intervention;
• Intracranial hemorrhage within prior 72 hours;
• Contraindications to platelet transfusion (e.g. thrombotic microangiopathies, heparin-induced thrombocytopenia, recent history of immune thrombocytopaenia, congenital platelet function defects);
• Known advance decision of refusing blood/blood component transfusions;

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (9)

Hamilton Health Sciences - Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Scarborough Health Network

Scarborough Village, Ontario, M1P 2V5, Canada

RECRUITING

Niagara Health

St. Catharines, Ontario, L2S 0A9, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Auckland City Hospital

Auckland, New Zealand

NOT YET RECRUITING

Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined)

London, United Kingdom

NOT YET RECRUITING

Related Links

• Website of the CEPEC trial

Study Officials

• Francois Lamontagne, MD, MSc

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Neill Adhikari, MDCM, MSc

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Helene Masse, RRT, MSc

CONTACT

1-819-346-1110; marie-helene.masse3@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adaptive Bayesian Platform trial evaluating multiple interventions in multiple domains.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 20, 2024
• Study Start: March 23, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); NZ (1); CA (7)