Evaluating vasopressor use in critically ill patients in ICUs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Canadian Critical Care Comparative Effectiveness Platform (CEPEC) is an international multi-centered randomized adaptive platform trial designed to evaluate various supportive care interventions routinely used in intensive care units. The trial will focus on the use of vasopressors in patients experiencing cardiovascular shock, assessing whether different dosing strategies can improve outcomes based on patient subgroups. By studying the effects of vasopressors across different mean arterial pressure targets, the trial aims to provide evidence-based guidance for their use in critically ill patients. This adaptive platform approach allows for the incorporation of multiple interventions over time, enhancing the trial's relevance and applicability.

Why it matters

Who can join: the full rules

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. Patient of ≥18 years of age;
2. Patient is 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. Patient who has 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.

Where it's running

• Centre hospitalier universitaire Dr-Georges-L.-Dumont
  Moncton, New Brunswick, Canada Recruiting
• Hamilton General Hospital
  Hamilton, Ontario, Canada Recruiting
• Hamilton Health Sciences - Juravinski Hospital
  Hamilton, Ontario, Canada Recruiting
• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting
• Scarborough Health Network
  Scarborough Village, Ontario, Canada Recruiting
• Niagara Health
  St. Catharines, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Francois Lamontagne, MD, MSc — Université de Sherbrooke
• Study coordinator: Marie-Helene Masse, RRT, MSc
• Email: marie-helene.masse3@usherbrooke.ca
• Phone: 1-819-346-1110

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.