NCT06605144

Canadian Critical Care Comparative Effectiveness Platform

Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en Soins Critiques (CEPEC)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,500 (estimated)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 and analgesia, and other interventions. 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).

Conditions

• Intensive Care Unit ICU
• Vasopressor
• Platelet
• Nutrition

Interventions

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

Timeline

• Start date: 2025-03-23
• Primary completion: 2029-12-31
• Completion: 2030-06-30
• First posted: 2024-09-20
• Last updated: 2026-03-27

Locations

8 sites across 3 countries: Canada, New Zealand, United Kingdom