Intensive Care Unit ICU, Nutrition, Platelet, Vasopressor
Conditions
Keywords
ICU, Adaptive platform trial, Vasopressor, Platelet, Enteral nutrition
Brief summary
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.
Detailed description
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).
Interventions
DRUG1- Vasopressor - Mean arterial pressure 56-60
Vasopressor(s) will be titrated according to 56-60 range.
DRUG2- Vasopressor - Mean arterial pressure 61-65
Vasopressor(s) will be titrated according to 61-65 range.
DRUG3- Vasopressor - Mean arterial pressure 66-70
Vasopressor(s) will be titrated according to 66-70 range.
DRUG4- Vasopressor - Mean arterial pressure 71-75
Vasopressor(s) will be titrated according to 71-75 range.
OTHER1- 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.
OTHER2- 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.
OTHER3- 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.
OTHER4- 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.
OTHER5- 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.
OTHEREnteral nutrition - Boluses
Given 3 times a day.
OTHEREnteral nutrition - Continuous
Given over 24-hour period
Sponsors
Université de Sherbrooke
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Adaptive Bayesian Platform trial evaluating multiple interventions in multiple domains.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressor Domain - Composite endpoint | 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 | 90 days | 90-day all-cause mortality |
| Nutrition Domain - Recruitment rate | 1 year | Recruitment rate of 2 patients per site per month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU. |
| Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU | Up to day 30 | POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU. |
| Vasopressor, Platelet and Nutrition Domains - Disposition at hospital discharge | At hospital discharge up to day 30 | Increased level of care as indicated by change of address vs. return to baseline \[previous home address\] |
| 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 | Transfusion-associated circulatory overload, transfusion-related acute lung injury, infections, anaphylaxis |
| Platelet Domain - Days alive and at home at day 90 | 90 days | — |
| Platelet Domain - Number of days without persistent organ dysfunction in the ICU | Up to day 90 | — |
| Platelet Domain - Health-related quality of life | 90 days | Evaluated using EQ-5D-5L questionnaire |
| Nutrition Domain - Diarrhea | 24 hours | Defined by the World Health Organization (WHO) definition (3 or greater liquids stools/24 hours) |
| Nutition Domain - Percentage of target nutritional intake | Over the course of the ICU stay up to day 30 | \>80% |
| Nutrition Domain - Vomiting | During ICU stay up to day 30 | Vomiting 2 or more times in a 24-hour period |
Countries
Canada, New Zealand, United Kingdom
Contacts
CONTACTMarie-Helene Masse, RRT, MSc
PRINCIPAL_INVESTIGATORFrancois Lamontagne, MD, MSc
Université de Sherbrooke
PRINCIPAL_INVESTIGATORNeill Adhikari, MDCM, MSc
Sunnybrook Research Institute
Outcome results
None listed