RecruitingPhase 3NCT06605144

Canadian Critical Care Comparative Effectiveness Platform

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

Sponsor

Université de Sherbrooke

Enrollment

5,500 participants

Start Date

Mar 23, 2025

Study Type

INTERVENTIONAL

Conditions

Nutrition Vasopressor Intensive Care Unit ICU Platelet

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria14

VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.
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.
Previously randomized into the CEPEC Vasopressor Domain or a confounding trial.
PLATELET DOMAIN
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.
NUTRITION DOMAIN
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 Criteria17

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);
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;
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.

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Interventions

DRUG1- Vasopressor - Mean arterial pressure 56-60

Vasopressor(s) will be titrated according to 56-60 range.

DRUG2- Vasopressor - Mean arterial pressure 61-65

Vasopressor(s) will be titrated according to 61-65 range.

DRUG3- Vasopressor - Mean arterial pressure 66-70

Vasopressor(s) will be titrated according to 66-70 range.

DRUG4- Vasopressor - Mean arterial pressure 71-75

Vasopressor(s) will be titrated according to 71-75 range.

OTHER1- 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.

OTHER2- 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.

OTHER3- 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.

OTHER4- 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.

OTHER5- 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.

OTHEREnteral nutrition - Boluses

Given 3 times a day.

OTHEREnteral nutrition - Continuous

Given over 24-hour period