Intensive Care Unit ICUVasopressorPlateletNutrition
Investigational drug(s) / intervention(s)
1- Vasopressor - Mean arterial pressure 56-602- Vasopressor - Mean arterial pressure 61-653- Vasopressor - Mean arterial pressure 66-704- Vasopressor - Mean arterial pressure 71-751- Platelet less than 10 x 109/L2- Platelet less than 20 x 109/L3- Platelet less than 30 x 109/L4- Platelet less than 40 x 109/L5- Platelet less than 50 x 109/LEnteral nutrition - BolusesEnteral nutrition - Continuous
1- Vasopressor - Mean arterial pressure 56-60: Vasopressor(s) will be titrated according to 56-60 range.
2- Vasopressor - Mean arterial pressure 61-65: Vasopressor(s) will be titrated according to 61-65 range.
3- Vasopressor - Mean arterial pressure 66-70: Vasopressor(s) will be titrated according to 66-70 range.
4- Vasopressor - Mean arterial pressure 71-75: Vasopressor(s) will be titrated according to 71-75 range.
1- 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.
2- 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.
3- 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.
4- 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.
5- 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.
Enteral nutrition - Boluses: Given 3 times a day.
Enteral nutrition - Continuous: Given over 24-hour period
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Vasopressor Domain - Composite endpoint — At hospital discharge up to day 30 Incorporate mortality, persistent organ dysfunction (POD) in the intensive care unit (ICU), days in hospital, and disposition at hospital discharge.
Platelet Domain - All cause mortality — 90 days 90-day all-cause mortality
Nutrition Domain - Recruitment rate — 1 year Recruitment rate of 2 patients per site per month.
Trial sites (11)
Facility
City
Region
Status
Centre hospitalier universitaire Dr-Georges-L.-Dumont
Moncton
New Brunswick
Recruiting
Hamilton Health Sciences - Juravinski Hospital
Hamilton
Ontario
Recruiting
The Ottawa Hospital
Ottawa
Ontario
Recruiting
Scarborough Health Network
Scarborough Village
Ontario
Recruiting
Niagara Health
St. Catharines
Ontario
Recruiting
Sunnybrook Health Sciences Centre
Toronto
Ontario
Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal
Quebec
Recruiting
CIUSSS NIM - Hôpital du Sacré-Coeur-de-Montréal
Montreal
Quebec
Recruiting
CIUSSS de l'Estrie - CHUS
Sherbrooke
Quebec
Recruiting
Auckland City Hospital
Auckland
New Zealand
Not Yet Recruiting
Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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