Comparing 3 approaches for intensive care unit ICU
Official title: Canadian Critical Care Comparative Effectiveness Platform
Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en Soins Critiques (CEPEC)
- Phase 3
- 3 groups
- Sites in Hamilton, Ottawa and 5 more cities
- Recruiting
Interventions (11)
- Medication
1- Vasopressor - Mean arterial pressure 56-60
Vasopressor(s) will be titrated according to 56-60 range.
- Medication
2- Vasopressor - Mean arterial pressure 61-65
Vasopressor(s) will be titrated according to 61-65 range.
- Medication
3- Vasopressor - Mean arterial pressure 66-70
Vasopressor(s) will be titrated according to 66-70 range.
- Medication
4- Vasopressor - Mean arterial pressure 71-75
Vasopressor(s) will be titrated according to 71-75 range.
- Other intervention
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.
- Other intervention
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.
- Other intervention
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.
- Other intervention
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.
- Other intervention
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.
- Other intervention
Enteral nutrition - Boluses
Given 3 times a day.
- Other intervention
Enteral nutrition - Continuous
Given over 24-hour period
Canadian Sites (7)
7 of 7 recruiting
- 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 de l'Estrie - CHUS
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for37 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Ongoing vasopressor infusion to treat hypotension, or would be used to treat clinician-defined hypotension as part of usual careStandard of careThe treatment normally given for a condition outside a study.Read more →;
- +MAP \<75 mmHg at any point;
- +Patient expected to be in the ICU for \>24 hours.
Exclusion
- −Adult patients (age ≥18 years) admitted to the ICU;
- −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);
- −More than 24 hours since meeting inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → in the ICU;
- −Previously randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → into the CEPEC Vasopressor Domain or a confounding trial.
- −PLATELET DOMAIN
- −Inclusion criteria:
- −Latest platelet count in this hospital admission \<50×109/L;
- −Planned to undergo a specified low-moderate bleeding risk invasive procedure.
- −Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −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
- −Inclusion criteria:
- −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 criteria:
- −Bowel obstruction or ischemia; active;
- −Has a post-pyloric small bowel feeding tube;
- −Active GI bleeding;
- −Patient who is chronically receiving enteral nutrition.
- −Patients who have had gastrointestinal (GI) surgery; in the last 3 months and deemed not ready to receive possible bolus nutrition;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives one or more of: 1- Vasopressor - Mean arterial pressure 56-60, 2- Vasopressor - Mean arterial pressure 61-65, 3- Vasopressor - Mean arterial pressure 66-70 and 4- Vasopressor - Mean arterial pressure 71-75.
Registry label: A: Vasopressor
Group B receives one or more of: 1- Platelet less than 10 x 109/L, 2- Platelet less than 20 x 109/L, 3- Platelet less than 30 x 109/L, 4- Platelet less than 40 x 109/L and 5- Platelet less than 50 x 109/L.
Registry label: B: Platelet
Group C receives one or more of: Enteral nutrition - Boluses and Enteral nutrition - Continuous.
Registry label: C: Nutrition
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 5,500 people.
The study is currently expected to finish around June 2030.
The main measurement is taken over: At hospital discharge up to day 30.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Vasopressor Domain - Composite endpointEndpointThe specific thing a study measures to answer its question.Read more → — measured over At hospital discharge up to day 30.
Platelet Domain - All cause mortality — measured over 90 days.
Nutrition Domain - Recruitment rate — measured over 1 year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06605144 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 1- Vasopressor - Mean arterial pressure 56-60Drug
Vasopressor(s) will be titrated according to 56-60 range.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About 2- Vasopressor - Mean arterial pressure 61-65Drug
Vasopressor(s) will be titrated according to 61-65 range.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About 3- Vasopressor - Mean arterial pressure 66-70Drug
Vasopressor(s) will be titrated according to 66-70 range.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About 4- Vasopressor - Mean arterial pressure 71-75Drug
Vasopressor(s) will be titrated according to 71-75 range.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Enteral nutrition - BolusesOther
Given 3 times a day.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Enteral nutrition - ContinuousOther
Given over 24-hour period
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At hospital discharge up to day 30.
The study as a whole is currently expected to finish around 2030-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 5,500 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Scarborough Village, Ontario, Canada; St. Catharines, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.