Canadian Critical Care Comparative Effectiveness Platform

Официальное название

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

Обзор

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.

Подробное описание

Many supportive therapies used daily in the ICU setting remain under-studied despite being resource-intensive. CEPEC aims to incorporate domains evaluating vasopressors, platelets, nutrition, sedation and analgesia, and other interventions.

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).

Вмешательства

• Препарат 1- Vasopressor - Mean arterial pressure 56-60
  Vasopressor(s) will be titrated according to 56-60 range.
• Препарат 2- Vasopressor - Mean arterial pressure 61-65
  Vasopressor(s) will be titrated according to 61-65 range.
• Препарат 3- Vasopressor - Mean arterial pressure 66-70
  Vasopressor(s) will be titrated according to 66-70 range.
• Препарат 4- Vasopressor - Mean arterial pressure 71-75
  Vasopressor(s) will be titrated according to 71-75 range.
• Другое 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.
• Другое 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.
• Другое 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.
• Другое 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.
• Другое 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.
• Другое Enteral nutrition - Boluses
  Given 3 times a day.

Первичные конечные точки

• Vasopressor Domain - Composite endpoint [Срок оценки: At hospital discharge up to day 30]
• Platelet Domain - All cause mortality [Срок оценки: 90 days]
• Nutrition Domain - Recruitment rate [Срок оценки: 1 year]

Вторичные конечные точки (12)

• Vasopressor, Platelet and Nutrition Domains - Mortality [Срок оценки: At hospital discharge up to day 30]
• Vasopressor, Platelet and Nutrition Domains - Persistent organ dysfunction (POD) in the ICU [Срок оценки: At hospital discharge up to day 30]
• Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU [Срок оценки: Up to day 30]
• Vasopressor, Platelet and Nutrition Domains - Disposition at hospital discharge [Срок оценки: At hospital discharge up to day 30]
• Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU [Срок оценки: At hospital discharge up to day 30]
• Platelet Domain - Mortality at discharge from hospital [Срок оценки: Discharge from hospital]
• Platelet Domain - Mortality at 1 year [Срок оценки: 1 year after randomization]
• Platelet Domain - Bleeding outcomes in hospital (major and fatal bleeds) [Срок оценки: During hospitalization]
• Platelet Domain - Transfusion complications [Срок оценки: During hospitalization]
• Platelet Domain - Days alive and at home at day 90 [Срок оценки: 90 days]
• Platelet Domain - Number of days without persistent organ dysfunction in the ICU [Срок оценки: Up to day 90]
• Platelet Domain - Health-related quality of life [Срок оценки: 90 days]

Критерии участия

VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.

Критерии включения

• 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.

Критерии исключения

• 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 criteria in the ICU;
• Previously randomized into the CEPEC Vasopressor Domain or a confounding trial.

PLATELET DOMAIN

Критерии включения

• 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.

Критерии исключения

• 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

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 7 центров

• Hamilton Health Sciences - Juravinski Hospital — Hamilton
• The Ottawa Hospital — Ottawa
• Scarborough Health Network — Scarborough Village
• Niagara Health — St. Catharines
• Sunnybrook Health Sciences Centre — Toronto
• Centre hospitalier de l'Université de Montréal (CHUM) — Montreal
• CIUSSS de l'Estrie - CHUS — Sherbrooke

Новая Зеландия · 1 центр

• Auckland City Hospital — Auckland

Великобритания · 1 центр

• Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Si — London

Идентификаторы

NCT: NCT06605144 · MP-31-2025-5600

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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