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.
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).
Eligibility
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.
NUTRITION DOMAIN
Inclusion criteria:
- Critically ill patients ≥18 years of age;
- Are invasively mechanically ventilated (including endotracheal tube or tracheostomy);
- Orogastric/nasogastric tube in place; or have an in dwelling percutaneous gastric tube (with confirmed placement);
- Treating team has started or has the intention of providing enteral nutrition.
Exclusion criteria:
- Patients who have had gastrointestinal (GI) surgery; in the last 3 months and deemed not ready to receive bolus nutrition;
- Bowel obstruction or ischemia; active;
- Has a post-pyloric small bowel feeding tube;
- Active GI bleeding;
- Exclude patients who are chronically receiving enteral nutrition.
