NCT06605144 Canadian Critical Care Comparative Effectiveness Platform
| NCT ID | NCT06605144 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Université de Sherbrooke |
| Condition | Intensive Care Unit ICU |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,500 participants |
| Start Date | 2025-03-23 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 5,500 participants in total. It began in 2025-03-23 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Francois Lamontagne, MD, MSc
PRINCIPAL INVESTIGATOR
Université de Sherbrooke
Frequently Asked Questions
Who can join the NCT06605144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intensive Care Unit ICU. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06605144 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 5,500 participants.
Is NCT06605144 currently recruiting?
Yes, NCT06605144 is actively recruiting participants. Contact the research team at marie-helene.masse3@usherbrooke.ca for enrollment information.
Where is the NCT06605144 trial being conducted?
This trial is being conducted at Hamilton, Canada, Ottawa, Canada, Scarborough Village, Canada, St. Catharines, Canada and 5 additional locations.
Who is sponsoring the NCT06605144 clinical trial?
NCT06605144 is sponsored by Université de Sherbrooke. The principal investigator is Francois Lamontagne, MD, MSc at Université de Sherbrooke. The trial plans to enroll 5,500 participants.