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Canadian Critical Care Comparative Effectiveness Platform

ConditionsIntensive Care Unit ICUVasopressorPlateletNutrition
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité de Sherbrooke

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 1- Vasopressor - Mean arterial pressure 56-60

    Drug

    Vasopressor(s) will be titrated according to 56-60 range.

  • 2- Vasopressor - Mean arterial pressure 61-65

    Drug

    Vasopressor(s) will be titrated according to 61-65 range.

  • 3- Vasopressor - Mean arterial pressure 66-70

    Drug

    Vasopressor(s) will be titrated according to 66-70 range.

  • 4- Vasopressor - Mean arterial pressure 71-75

    Drug

    Vasopressor(s) will be titrated according to 71-75 range.

  • 1- Platelet less than 10 x 109/L

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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

    Other intervention

    Given 3 times a day.

  • Enteral nutrition - Continuous

    Other intervention

    Given over 24-hour period

Treatment groups

5,500 Participants
are divided into 3 treatment groups
Group A: VasopressorOther 4 interventions
Group B: PlateletOther 5 interventions
Group C: NutritionOther 2 interventions

Trial outcomes

Primary outcomes

1

Vasopressor Domain - Composite endpoint

Incorporate mortality, persistent organ dysfunction (POD) in the intensive care unit (ICU), days in hospital, and disposition at hospital discharge.

Time frame
At hospital discharge up to day 30
2

Platelet Domain - All cause mortality

90-day all-cause mortality

Time frame
90 days
3

Nutrition Domain - Recruitment rate

Recruitment rate of 2 patients per site per month.

Time frame
1 year

Secondary outcomes

1

Vasopressor, Platelet and Nutrition Domains - Mortality

Time frame
At hospital discharge up to day 30
2

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.

Time frame
At hospital discharge up to day 30
3

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.

Time frame
Up to day 30
4

Vasopressor, Platelet and Nutrition Domains - Disposition at hospital discharge

Increased level of care as indicated by change of address vs. return to baseline \[previous home address\]

Time frame
At hospital discharge up to day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université de Sherbrooke

Lead sponsor

Hamilton Health Sciences Corporation

Collaborator

Source ClinicalTrials.gov
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