Clinical trial NCT06605144: Canadian Critical Care Comparative Effectiveness Platform
Official title: Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en Soins Critiques (CEPEC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intensive Care Unit ICU
Keywords: ICU
Adaptive platform trial
Vasopressor
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 6500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Adaptive Bayesian Platform trial evaluating multiple interventions in multiple domains.
Primary purpose: SUPPORTIVE_CARE

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. 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.

Eligibility criteria: CEPEC PLATFORM 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.

Primary outcomes:
measure: Composite endpoint
timeFrame: At hospital discharge up to day 30
Secondary outcomes:
measure: Mortality
timeFrame: At hospital discharge up to day 30
measure: Persistent organ dysfunction (POD) in the ICU
timeFrame: At hospital discharge up to day 30
measure: Days in hospital
timeFrame: At hospital discharge up to day 30
measure: Disposition at hospital discharge
timeFrame: At hospital discharge up to day 30
measure: Number of days without persistent organ dysfunction (POD) in the ICU
timeFrame: At hospital discharge up to day 30
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Centre of the CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Francois Lamontagne, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: