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Canadian Critical Care Comparative Effectiveness Platform

RecruitingPhase 3

Sponsor: Université de Sherbrooke

Conditions: Intensive Care Unit ICU, Vasopressor, Platelet, Nutrition

Interventions: 1- Vasopressor - Mean arterial pressure 56-60, 2- Vasopressor - Mean arterial pressure 61-65, 3- Vasopressor - Mean arterial pressure 66-70, 4- Vasopressor - Mean arterial pressure 71-75, 1- Platelet less than 10 x 109/L

Countries: Canada, New Zealand, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor 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. MAP \<75 mmHg at any point;
3. Patient expected to be in the ICU for \>24 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 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. Patient expected to become an organ donor (Donor Neurologic Death - DND or Donation After Circulatory Death - DCD);
7. More than 24 hours since meeting inclusion criteria in the ICU;
8. Previously randomized into the CEPEC Vasopressor Domain or a confounding trial.

PLATELET DOMAIN

Inclusion criteria:

1. Adult patients (age ≥18 years) admitted to the ICU;
2. Latest platelet count in this hospital admission \<50×109/L;
3. Planned to undergo a specified low-moderate bleeding risk invasive procedure.

Exclusion criteria:

1. Ongoing major hemorrhage requiring blood products and/or surgical/ radiological intervention;
2. Intracranial hemorrhage within prior 72 hours;
3. Contraindications to platelet transfusion (e.g. thrombotic microangiopathies, heparin-induced thrombocytopenia, recent history of immune thrombocytopaenia, congenital platelet function defects);
4. Known advance decision of refusing blood/blood component transfusions;
5. Acute promyelocytic leukemia (APML);
6. Death perceived as imminent or admission for palliation;
7. Previously randomized into the CEPEC Platelet Domain or the T4P Trial;
8. Fulfilled all the inclusion criteria and none of the exclusion criteria ≥72 hours.

NUTRITION DOMAIN

Inclusion criteria:

1. Critically ill patients ≥18 years of age;
2. Are invasively mechanically ventilated (including endotracheal tube or tracheostomy);
3. Orogastric/nasogastric tube in place; or have an in dwelling percutaneous gastric tube (with confirmed placement);
4. Treating team has started or has the intention of providing enteral nutrition.

Exclusion criteria:

1. Patients who have had gastrointestinal (GI) surgery; in the last 3 months and deemed not ready to receive possible bolus nutrition;
2. Bowel obstruction or ischemia; active;
3. Has a post-pyloric small bowel feeding tube;
4. Active GI bleeding;
5. Patient who is chronically receiving enteral nutrition.

Locations (9)

Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Scarborough Village, Ontario, Canada
St. Catharines, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Auckland, New Zealand
London, United Kingdom