Intensive Care Unit ICUPhase 3CEPECNCT06605144
Canadian Critical Care Comparative Effectiveness Platform
A Phase 3 study testing 1- Vasopressor - Mean arterial pressure 56-60, 2- Vasopressor - Mean arterial pressure 61-65 and 3- Vasopressor - Mean arterial pressure 66-70 in people with Intensive Care Unit ICU and Vasopressor, run by Université de Sherbrooke at 11 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit ICU, Vasopressor, Platelet
- What is being tested?
- 1- Vasopressor - Mean arterial pressure 56-60, 2- Vasopressor - Mean arterial pressure 61-65 and 3- Vasopressor - Mean arterial pressure 66-70
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,500 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 23 Mar 2025to 30 Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Patient expected to be in the ICU for >24 hours.
- 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.
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- 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.
Who cannot join
- 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 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);
- Patient expected to become an organ donor (Donor Neurologic Death - DND or Donation After Circulatory Death - DCD);
Show all 23Show fewer
- More than 24 hours since meeting inclusion criteria in the ICU;
- Previously randomized into the CEPEC Vasopressor Domain or a confounding trial.
- PLATELET DOMAIN
- 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
- Patients who have had gastrointestinal (GI) surgery; in the last 3 months and deemed not ready to receive possible bolus nutrition;
- Bowel obstruction or ischemia; active;
- Has a post-pyloric small bowel feeding tube;
- Active GI bleeding;
- Patient who is chronically receiving enteral nutrition.
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
Canada9 sites, 9 recruiting
- Recruiting
Hamilton Health Sciences - Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Tina Millen, 905-521-2100, millent@mcmaster.ca
Bram Rochwerg
- Recruiting
Centre hospitalier universitaire Dr-Georges-L.-Dumont
Moncton, New Brunswick, E1C 2Z3
Emma Boisvert, 506-869-7391, Emma.Boisvert@VitaliteNB.ca
Rémi Leblanc
- Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1
Melissa Gagnon-Hamelin, 514 890-8000 ext. 31750, melissa.gagnon-hamelin.chum@ssss.gouv.qc.ca
Francois-Martin Carrier
- Recruiting
CIUSSS NIM - Hôpital du Sacré-Coeur-de-Montréal
Montreal, Quebec, H4J 1C5
Virginie Williams, 514-338-2222 ext. 1472, virginie.williams.cnmtl@ssss.gouv.qc.ca
Yiorgos Alexandros Cavayas
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Irene Watpool, 613-737-8724, iwatpool@ohri.ca
Alexandre Tran
- Recruiting
Scarborough Health Network
Scarborough Village, Ontario, M1P 2V5
Joshua Craig, 416-438-2911, jcraig@shn.ca
Christopher Yarnell
- Recruiting
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1H 5N4
Marie-Helene Masse, RRT, MSc, 819-346-1110 ext. 14173, marie-helene.masse3@usherbrooke.ca
Monica Sean, PhD, 819-346-1110 ext. 14266, monica.sean@usherbrooke.ca
- Recruiting
Niagara Health
St. Catharines, Ontario, L2S 0A9
Jennifer Tsang, 905-684-7271, jennifer.tsang@mail.utoronto.ca
Jennifer Tsang
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Nicole Marinoff, 416-480-4522, Nicole.Marinoff@sunnybrook.ca
Neill Adhikari
New Zealand1 site, 1 recruiting
- Not yet recruiting
Auckland City Hospital
Auckland
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined)
London
About this study
Official title: Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en Soins Critiques (CEPEC)
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.
Read the detailed description
Many supportive therapies used daily in the ICU setting remain under-studied despite being resource-intensive. CEPEC aims to incorporate domains evaluating vasopressors, nutrition, transfusions, 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.
- Conditions
- Intensive Care Unit ICU, Vasopressor, Platelet, Nutrition
- Being tested
- 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
- Keywords
- ICU, Adaptive platform trial, Vasopressor, Platelet, Enteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1- Vasopressor - Mean arterial pressure 56-60Drug
Vasopressor(s) will be titrated according to 56-60 range.
2- Vasopressor - Mean arterial pressure 61-65Drug
Vasopressor(s) will be titrated according to 61-65 range.
3- Vasopressor - Mean arterial pressure 66-70Drug
Vasopressor(s) will be titrated according to 66-70 range.
4- Vasopressor - Mean arterial pressure 71-75Drug
Vasopressor(s) will be titrated according to 71-75 range.
1- Platelet less than 10 x 109/LOther
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/LOther
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/LOther
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/LOther
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/LOther
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 - BolusesOther
Given 3 times a day.
Enteral nutrition - ContinuousOther
Given over 24-hour period
| Study group | Role | What they receive |
|---|---|---|
| Vasopressor | Other | 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. Receives: 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 |
| Platelet | Other | 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. Receives: 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 |
| Nutrition | Other | 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. Receives: Other: Enteral nutrition - Boluses; Other: Enteral nutrition - Continuous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressor Domain - Composite endpoint
Incorporate mortality, persistent organ dysfunction (POD) in the intensive care unit (ICU), days in hospital, and disposition at hospital discharge.
Measured: At hospital discharge up to day 30
Platelet Domain - All cause mortality
90-day all-cause mortality
Measured: 90 days
Nutrition Domain - Recruitment rate
Recruitment rate of 2 patients per site per month.
Measured: 1 year
Secondary outcomes (15)
Vasopressor, Platelet and Nutrition Domains - Mortality
Measured: At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Persistent organ dysfunction (POD) in the ICU
POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU.
Measured: At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU
POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU.
Measured: Up to day 30
Vasopressor, Platelet and Nutrition Domains - Disposition at hospital discharge
Increased level of care as indicated by change of address vs. return to baseline [previous home address]
Measured: At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU
POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU.
Measured: At hospital discharge up to day 30
Platelet Domain - Mortality at discharge from hospital
Measured: Discharge from hospital
Platelet Domain - Mortality at 1 year
Measured: 1 year after randomization
Platelet Domain - Bleeding outcomes in hospital (major and fatal bleeds)
Measured: During hospitalization
Platelet Domain - Transfusion complications
Transfusion-associated circulatory overload, transfusion-related acute lung injury, infections, anaphylaxis
Measured: During hospitalization
Platelet Domain - Days alive and at home at day 90
Measured: 90 days
Platelet Domain - Number of days without persistent organ dysfunction in the ICU
Measured: Up to day 90
Platelet Domain - Health-related quality of life
Evaluated using EQ-5D-5L questionnaire
Measured: 90 days
Nutrition Domain - Diarrhea
Defined by the World Health Organization (WHO) definition (3 or greater liquids stools/24 hours)
Measured: 24 hours
Nutition Domain - Percentage of target nutritional intake
>80%
Measured: Over the course of the ICU stay up to day 30
Nutrition Domain - Vomiting
Vomiting 2 or more times in a 24-hour period
Measured: During ICU stay up to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start23 Mar 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adaptive Bayesian Platform trial evaluating multiple interventions in multiple domains.
- Masking
- None (open label)
- Enrolment
- 5,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Francois Lamontagne, MD, MSc, Principal investigator, Université de SherbrookeNeill Adhikari, MDCM, MSc, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605144
- Sponsor's protocol ID
- MP-31-2025-5600
- Acronym
- CEPEC
- Status last verified
- Aug 2026
- First submitted
- 10 Sep 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en Soins Critiques (CEPEC)
- ClinicalTrials.gov ID
- NCT06605144
- Acronym / sponsor ID
- CEPEC / MP-31-2025-5600
- Conditions
- Intensive Care Unit ICU, Vasopressor, Platelet, Nutrition
- Keywords
- ICU, Adaptive platform trial, Vasopressor, Platelet, Enteral nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Many supportive therapies used daily in the ICU setting remain under-studied despite being resource-intensive. CEPEC aims to incorporate domains evaluating vasopressors, nutrition, transfusions, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Adaptive Bayesian Platform trial evaluating multiple interventions in multiple domains.
| Arm | Type | Receives |
|---|---|---|
| Vasopressor | Other | 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 71-75Participants 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. |
| Platelet | Other | 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/LThrombocytopenic 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. |
| Nutrition | Other | Other: Enteral nutrition - Boluses, Other: Enteral nutrition - ContinuousThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
- Patient expected to be in the ICU for >24 hours.
- Adult patients (age ≥18 years) admitted to the ICU;
- Latest platelet count in this hospital admission <50×109/L;
Key exclusion criteria (23 listed)
- 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 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1- Vasopressor - Mean arterial pressure 56-60Vasopressor(s) will be titrated according to 56-60 range. | Drug | Vasopressor |
| 2- Vasopressor - Mean arterial pressure 61-65Vasopressor(s) will be titrated according to 61-65 range. | Drug | Vasopressor |
| 3- Vasopressor - Mean arterial pressure 66-70Vasopressor(s) will be titrated according to 66-70 range. | Drug | Vasopressor |
| 4- Vasopressor - Mean arterial pressure 71-75Vasopressor(s) will be titrated according to 71-75 range. | Drug | Vasopressor |
| 1- Platelet less than 10 x 109/LOnce 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. | Other | Platelet |
| 2- Platelet less than 20 x 109/LOnce 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. | Other | Platelet |
| 3- Platelet less than 30 x 109/LOnce 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. | Other | Platelet |
| 4- Platelet less than 40 x 109/LOnce 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. | Other | Platelet |
| 5- Platelet less than 50 x 109/LOnce 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. | Other | Platelet |
| Enteral nutrition - BolusesGiven 3 times a day. | Other | Nutrition |
| Enteral nutrition - ContinuousGiven over 24-hour period | Other | Nutrition |
Primary outcome
Vasopressor Domain - Composite endpoint
Time frame: 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
Time frame: 90 days
90-day all-cause mortality
Nutrition Domain - Recruitment rate
Time frame: 1 year
Recruitment rate of 2 patients per site per month.
15 secondary outcomes
Vasopressor, Platelet and Nutrition Domains - Mortality
Time frame: At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Persistent organ dysfunction (POD) in the ICU
Time frame: At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU
Time frame: Up to day 30
Vasopressor, Platelet and Nutrition Domains - Disposition at hospital discharge
Time frame: At hospital discharge up to day 30
Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU
Time frame: At hospital discharge 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
Time frame: During hospitalization
Platelet Domain - Days alive and at home at day 90
Time frame: 90 days
Platelet Domain - Number of days without persistent organ dysfunction in the ICU
Time frame: Up to day 90
Platelet Domain - Health-related quality of life
Time frame: 90 days
Nutrition Domain - Diarrhea
Time frame: 24 hours
Nutition Domain - Percentage of target nutritional intake
Time frame: Over the course of the ICU stay up to day 30
Nutrition Domain - Vomiting
Time frame: During ICU stay up to day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Website of the CEPEC trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francois Lamontagne, MD, MSc principal investigator
Université de Sherbrooke
Neill Adhikari, MDCM, MSc principal investigator
Sunnybrook Research Institute
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1- Vasopressor - Mean arterial pressure 56-60, 2- Vasopressor - Mean arterial pressure 61-65 and 3- Vasopressor - Mean arterial pressure 66-70 in people with Intensive Care Unit ICU and Vasopressor, run by Université de Sherbrooke at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada, New Zealand, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Helene Masse, RRT, MSc (1-819-346-1110 ext. 14173, marie-helene.masse3@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasopressor Domain - Composite endpoint (time frame: At hospital discharge up to day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.