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RECRUITING Phase 3 ClinicalTrials.gov

Canadian Critical Care Comparative Effectiveness Platform

Sponsor: Université de Sherbrooke • ClinicalTrials.gov ID: NCT06605144

Registry updated: 2026-09-22
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Description

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.

Interventions

  • 1- Vasopressor - Mean arterial pressure 56-60 (Drug)
    Vasopressor(s) will be titrated according to 56-60 range.
  • 2- Vasopressor - Mean arterial pressure 61-65 (Drug)
    Vasopressor(s) will be titrated according to 61-65 range.
  • 3- Vasopressor - Mean arterial pressure 66-70 (Drug)
    Vasopressor(s) will be titrated according to 66-70 range.
  • 4- Vasopressor - Mean arterial pressure 71-75 (Drug)
    Vasopressor(s) will be titrated according to 71-75 range.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Enteral nutrition - Boluses (Other)
    Given 3 times a day.
  • Enteral nutrition - Continuous (Other)
    Given over 24-hour period

Eligibility criteria

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. Critically ill patients ≥18 years of age; 2. Are 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. Patients who have 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.

Conditions

Intensive Care Unit ICU Vasopressor Platelet Nutrition

Locations

  • Centre hospitalier universitaire Dr-Georges-L.-Dumont — Moncton, New Brunswick, Canada
  • Hamilton Health Sciences - Juravinski Hospital — Hamilton, Ontario, Canada
  • The Ottawa Hospital — Ottawa, Ontario, Canada
  • Scarborough Health Network — Scarborough Village, Ontario, Canada
  • Niagara Health — St. Catharines, Ontario, Canada
  • Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
  • Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada
  • CIUSSS NIM - Hôpital du Sacré-Coeur-de-Montréal — Montreal, Quebec, Canada
  • CIUSSS de l'Estrie - CHUS — Sherbrooke, Quebec, Canada
  • Auckland City Hospital — Auckland, New Zealand
  • Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined) — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record