Evaluating vasopressor use in critically ill patients in ICUs

Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en Soins Critiques (CEPEC)

This study is testing different ways to use vasopressors in critically ill patients with cardiovascular shock to see if certain dosing strategies can help them recover better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Université de Sherbrooke (Academic / other)
• Locations: 8 sites (Hamilton, Ontario and 7 other locations)
• Trial ID: NCT06605144 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are critically ill patients admitted to an ICU who require vasopressor therapy for hypotension.

Not a fit: Patients with strictly palliative care goals or those predicted to die within 24 hours will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for critically ill patients, optimizing vasopressor use and potentially enhancing patient outcomes.

How similar studies have performed: Other studies have explored vasopressor use in critical care settings, but the adaptive platform approach of this trial is relatively novel.

Eligibility criteria

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 (or lower than the upper value of the highest mean arterial pressure (MAP) target range activated locally);
3. Patient expected to be in the ICU for \>48 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 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. More than 24 hours since meeting inclusion criteria in the ICU;
7. 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. Critically ill patients ≥18 years of age;
2. Are 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. Patients who have had gastrointestinal (GI) surgery; in the last 3 months and deemed not ready to receive bolus nutrition;
2. Bowel obstruction or ischemia; active;
3. Has a post-pyloric small bowel feeding tube;
4. Active GI bleeding;
5. Exclude patients who are chronically receiving enteral nutrition.

Where this trial is running

Hamilton, Ontario and 7 other locations

• 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)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
• CIUSSS de l'Estrie - CHUS — Sherbrooke, Quebec, Canada (Recruiting)
• Auckland City Hospital — Auckland, New Zealand (Not_yet_recruiting)
• Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined) — London, United Kingdom (Not_yet_recruiting)

Study contacts

• Principal investigator: Francois Lamontagne, MD, MSc — Université de Sherbrooke
• Study coordinator: Marie-Helene Masse, RRT, MSc

Conditions Intensive Care Unit ICU; Vasopressor; Platelet; Nutrition; ICU; Adaptive platform trial; Enteral nutrition