Overview
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.
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
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:
- Ongoing vasopressor infusion to treat hypotension, or would be used to treat clinician-defined hypotension as part of usual care;
- 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);
- Patient expected to be in the ICU for more than 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.