Status:
RECRUITING
Canadian Critical Care Comparative Effectiveness Platform
Lead Sponsor:
Université de Sherbrooke
Conditions:
Intensive Care Unit ICU
Vasopressor
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 tria...
Detailed Description
Many supportive therapies used daily in the ICU setting remain under-studied despite being resource-intensive. CEPEC aims to incorporate domains evaluating vasopressors, platelets, nutrition, sedation...
Eligibility Criteria
Inclusion
- VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.
- Inclusion criteria:
- 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 (or lower than the upper value of the highest mean arterial pressure (MAP) target range activated locally);
- Patient expected to be in the ICU for \>48 hours.
- Exclusion criteria:
- 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 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);
- More than 24 hours since meeting inclusion criteria in the ICU;
- Previously randomized into the CEPEC Vasopressor Domain or a confounding trial.
- PLATELET DOMAIN
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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;
- Acute promyelocytic leukemia (APML);
- Death perceived as imminent or admission for palliation;
- Previously randomized into the CEPEC platelet domain or the T4P Trial;
- Fulfilled all the inclusion criteria and none of the exclusion criteria ≥72 hours.
Exclusion
Key Trial Info
Start Date :
March 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
6900 Patients enrolled
Trial Details
Trial ID
NCT06605144
Start Date
March 23 2025
End Date
June 30 2030
Last Update
September 9 2025
Active Locations (8)
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1
Hamilton Health Sciences - Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3
2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
3
Scarborough Health Network
Scarborough Village, Ontario, Canada, M1P 2V5
4
Niagara Health
St. Catharines, Ontario, Canada, L2S 0A9