Canadian Critical Care Comparative Effectiveness Platform

Not Applicable

Recruiting

• Conditions: Intensive Care Unit ICU
• Interventions: Other: 1- Vasopressors - Mean arterial pressure 55-59; Other: 2- Vasopressors - Mean arterial pressure 60-65; Other: 3- Vasopressors - Mean arterial pressure 66-69; Other: 4- Vasopressors - Mean arterial pressure 70-75

• Registration Number: NCT06605144
• Lead Sponsor: Université de Sherbrooke

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.

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.

The first domain studied will be vasopressors. We 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.

Study Timeline

• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-20
• Status Verified: 2025-03
• Study Start: 2025-03-17
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2029-12-31
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6500

Inclusion Criteria

• Admitted to a participating intensive care unit (ICU).

CEPEC PLATFORM

Exclusion Criteria

• Goals of care are strictly palliative or expected to become strictly palliative within 24 hours
• Death predicted by the treating team to occur within 24 hours.

To be included in any of the following DOMAINS the participant must met eligibility for the PLATFORM (as listed above).

VASOPRESSORS 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. Mean arterial pressure (MAP) less than 75 mmHg at any point (or lower than the upper value of the highest MAP target range activated locally);
3. Patient expected to be in the ICU for more than 48 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 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. More than 24 hours since meeting inclusion criteria in the ICU;
7. Previously randomized into the CEPEC Vasopressor Domain or a confounding trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Vasopressors	1- Vasopressors - Mean arterial pressure 55-59	-
Vasopressors	2- Vasopressors - Mean arterial pressure 60-65	-
Vasopressors	3- Vasopressors - Mean arterial pressure 66-69	-
Vasopressors	4- Vasopressors - Mean arterial pressure 70-75	-

Primary Outcome Measures

Name	Time	Method
Composite endpoint	At hospital discharge up to day 30	Incorporate mortality, persistent organ dysfunction (POD) in the intensive care unit (ICU), days in hospital, and disposition at hospital discharge.

Secondary Outcome Measures

Name	Time	Method
Mortality	At hospital discharge up to day 30
Persistent organ dysfunction (POD) in the ICU	At hospital discharge up to day 30	POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU.
Days in hospital	At hospital discharge up to day 30
Disposition at hospital discharge	At hospital discharge up to day 30	Vital status (alive or dead)
Number of days without persistent organ dysfunction (POD) in the ICU	At hospital discharge up to day 30	POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU.

Trial Locations

Locations (1)

Research Centre of the CHUS; 🇨🇦 Sherbrooke, Quebec, Canada