A Phase 3 interventional study of 1- Vasopressor - Mean arterial pressure 56-60 and 2- Vasopressor - Mean arterial pressure 61-65 in Intensive Care Unit ICU, Vasopressor and Platelet, sponsored by Université de Sherbrooke. Recruiting at 13 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Université de Sherbrooke · Phase 3, Interventional, and Treatment
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.
Many supportive therapies used daily in the ICU setting remain under-studied despite being resource-intensive. CEPEC aims to incorporate domains evaluating vasopressors and inotropes, nutrition, transfusions, sedation, correction of electrolyte deficits, sedation and analgesia, airway management, end-of-life care practices and other interventions.
Domains refer to categories of patient care for which interventions are being evaluated in a randomized controlled trial (RCT) within the platform.
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).
INITIATIVES Initiatives are cross-cutting non-randomized studies nested within the platform that are relevant to all domains. Examples include a parallel observational study initiative, which aims to collect data about usual care and outcomes directly relevant to each domain. The goal is to describe the representativeness of domain results and to assess for protocol misalignment. Similarly, the living knowledge synthesis and health economics initiatives aim to generate meta-analyses and cost-effectiveness analyses alongside each trial conducted in the platform.
Université de Sherbrooke is the lead sponsor of 295 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 5, 2026. See what changed
VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.
Inclusion criteria:
Exclusion criteria:
DOMAIN
Inclusion criteria:
Exclusion criteria:
NUTRITION DOMAIN
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive vasopressor(s) and their mean arterial pressure will be titrated according to the group they are randomized to (group 1: 56-60 mmHg; group 2: 61-65 mmHg; group 3: 66-70 mmHg; group 4: 71-75 mmHg). Physicians will have the liberty of restricting the randomization to at least 2 contiguous ranges.
Drug: 1- Vasopressor - Mean arterial pressure 56-60 · Drug: 2- Vasopressor - Mean arterial pressure 61-65 · Drug: 3- Vasopressor - Mean arterial pressure 66-70 · Drug: 4- Vasopressor - Mean arterial pressure 71-75
Thrombocytopenic intensive care unit (ICU) patients (platelet count \<50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.
Other: 1- Platelet less than 10 x 109/L · Other: 2- Platelet less than 20 x 109/L · Other: 3- Platelet less than 30 x 109/L · Other: 4- Platelet less than 40 x 109/L · Other: 5- Platelet less than 50 x 109/L
The intervention is bolus feeding (given 3 times a day to meet nutritional targets) with formula type left to the discretion of the precribing team. With 2 hours between each "feed". The control is continuous feeding (over 24-hour period) with formula type left to the discretion of the prescribing team, which is the current standard of care.
Other: Enteral nutrition - Boluses · Other: Enteral nutrition - Continuous
Vasopressor(s) will be titrated according to 56-60 range.
Vasopressor(s) will be titrated according to 61-65 range.
Vasopressor(s) will be titrated according to 66-70 range.
Vasopressor(s) will be titrated according to 71-75 range.
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.
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.
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.
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.
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.
Given 3 times a day.
Given over 24-hour period
Vasopressor Domain - 30-day ordinal outcome
Incorporate mortality, persistent organ dysfunction (POD) in the ICU, hospitalization, discharge to a location providing more health services than at the patient's baseline residence, and discharge to baseline level residence.
Time frame: At hospital discharge up to day 30
Platelet Domain - All cause mortality
90-day all-cause mortality
Time frame: 90 days
Nutrition Domain - Recruitment rate
Recruitment rate of 2 patients per site per month.
Time frame: 1 year
Vasopressor, Platelet and Nutrition Domains - Each component of the 30-day ordinal primary outcome
1. Mortality 2. POD in the ICU 3. Hospitalization 4. Discharge to a location providing more health services than at the patient's baseline residence 5. Discharge to baseline level residence.
Time frame: At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Days free of POD to day 30
POD is defined as a vasopressor infusion, invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen (delivered via nasal prongs or cannula by a specialized device, with a FiO2 ≥0.4 and at a flow rate ≥30L/min), or new renal replacement therapy.
Time frame: At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Hospital days up to day 30
Time frame: Up to day 30
Vasopressor, Platelet and Nutrition Domains - ICU days to day 30
Time frame: Up to day 30
Platelet Domain - Mortality at discharge from hospital
Time frame: Discharge from hospital
Platelet Domain - Mortality at 1 year
Time frame: 1 year after randomization
Platelet Domain - Bleeding outcomes in hospital (major and fatal bleeds)
Time frame: During hospitalization
Platelet Domain - Transfusion complications
Transfusion-associated circulatory overload, transfusion-related acute lung injury, infections, anaphylaxis
Time frame: During hospitalization
Platelet Domain - Days alive and at home at day 90
Time frame: 90 days
Platelet Domain - Number of days without POD in the ICU
Time frame: Up to day 90
Platelet Domain - Health-related quality of life
Evaluated using EQ-5D-5L questionnaire
Time frame: 90 days
Nutrition Domain - Diarrhea
Defined by the World Health Organization (WHO) definition (3 or greater liquids stools/24 hours)
Time frame: 24 hours
Nutition Domain - Percentage of target nutritional intake
\>80%
Time frame: Over the course of the ICU stay up to day 30
Nutrition Domain - Vomiting
Vomiting 2 or more times in a 24-hour period
Time frame: During ICU stay up to day 30
Plan to share: No
Started Mar 2025 (actual). Primary completion is estimated for Dec 2029, 57 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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