Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en Soins Critiques (CEPEC)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5,500
- 试验地点
- 9
- 主要终点
- Vasopressor Domain - Composite endpoint
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.
- •Inclusion criteria:
- •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.
排除标准
- •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
- •Inclusion criteria:
- •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.
- •Exclusion criteria:
- •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:
- •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.
研究组 & 干预措施
Vasopressor
Participants will receive vasopressor(s) and their mean arterial pressure will be titrated according to the group they are randomized to (group 1: 56-60 mmHg; group 2: 61-65 mmHg; group 3: 66-70 mmHg; group 4: 71-75 mmHg). Physicians will have the liberty of restricting the randomization to at least 2 contiguous ranges
干预措施: 1- Vasopressor - Mean arterial pressure 56-60 (Drug)
Vasopressor
Participants will receive vasopressor(s) and their mean arterial pressure will be titrated according to the group they are randomized to (group 1: 56-60 mmHg; group 2: 61-65 mmHg; group 3: 66-70 mmHg; group 4: 71-75 mmHg). Physicians will have the liberty of restricting the randomization to at least 2 contiguous ranges
干预措施: 2- Vasopressor - Mean arterial pressure 61-65 (Drug)
Vasopressor
Participants will receive vasopressor(s) and their mean arterial pressure will be titrated according to the group they are randomized to (group 1: 56-60 mmHg; group 2: 61-65 mmHg; group 3: 66-70 mmHg; group 4: 71-75 mmHg). Physicians will have the liberty of restricting the randomization to at least 2 contiguous ranges
干预措施: 3- Vasopressor - Mean arterial pressure 66-70 (Drug)
Vasopressor
Participants will receive vasopressor(s) and their mean arterial pressure will be titrated according to the group they are randomized to (group 1: 56-60 mmHg; group 2: 61-65 mmHg; group 3: 66-70 mmHg; group 4: 71-75 mmHg). Physicians will have the liberty of restricting the randomization to at least 2 contiguous ranges
干预措施: 4- Vasopressor - Mean arterial pressure 71-75 (Drug)
Platelet
Thrombocytopenic intensive care unit (ICU) patients (platelet count <50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.
干预措施: 1- Platelet less than 10 x 109/L (Other)
Platelet
Thrombocytopenic intensive care unit (ICU) patients (platelet count <50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.
干预措施: 2- Platelet less than 20 x 109/L (Other)
Platelet
Thrombocytopenic intensive care unit (ICU) patients (platelet count <50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.
干预措施: 3- Platelet less than 30 x 109/L (Other)
Platelet
Thrombocytopenic intensive care unit (ICU) patients (platelet count <50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.
干预措施: 4- Platelet less than 40 x 109/L (Other)
Platelet
Thrombocytopenic intensive care unit (ICU) patients (platelet count <50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.
干预措施: 5- Platelet less than 50 x 109/L (Other)
Nutrition
The intervention is bolus feeding (given 3 times a day to meet nutritional targets) with formula type left to the discretion of the precribing team. With 2 hours between each "feed".
The control is continuous feeding (over 24-hour period) with formula type left to the discretion of the prescribing team, which is the current standard of care.
干预措施: Enteral nutrition - Boluses (Other)
Nutrition
The intervention is bolus feeding (given 3 times a day to meet nutritional targets) with formula type left to the discretion of the precribing team. With 2 hours between each "feed".
The control is continuous feeding (over 24-hour period) with formula type left to the discretion of the prescribing team, which is the current standard of care.
干预措施: Enteral nutrition - Continuous (Other)
结局指标
主要结局
Vasopressor Domain - Composite endpoint
时间窗: At hospital discharge up to day 30
Incorporate mortality, persistent organ dysfunction (POD) in the intensive care unit (ICU), days in hospital, and disposition at hospital discharge.
Platelet Domain - All cause mortality
时间窗: 90 days
90-day all-cause mortality
Recruitment rate
时间窗: 1 year
Recruitment rate of 2 patients per site per month.
次要结局
- Platelet Domain - Number of days without persistent organ dysfunction in the ICU(Up to day 90)
- Platelet Domain - Mortality at discharge from hospital(Discharge from hospital)
- Platelet Domain - Mortality at 1 year(1 year after randomization)
- Platelet Domain - Bleeding outcomes in hospital (major and fatal bleeds)(During hospitalization)
- Platelet Domain - Transfusion complications(During hospitalization)
- Platelet Domain - Days alive and at home at day 90(90 days)
- Platelet Domain - Health-related quality of life(90 days)
- Vasopressor, Platelet and Nutrition Domains - Mortality(At hospital discharge up to day 30)
- Vasopressor, Platelet and Nutrition Domains - Persistent organ dysfunction (POD) in the ICU(At hospital discharge up to day 30)
- Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU(Up to day 30)
- Vasopressor, Platelet and Nutrition Domains - Disposition at hospital discharge(At hospital discharge up to day 30)
- Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU(At hospital discharge up to day 30)
- Nutrition Domain - Diarrhea(24 hours)
- Nutition Domain - Percentage of target nutritional intake(Over the course of the ICU stay up to day 30)
- Nutrition Domain - Vomiting(During ICU stay up to day 30)