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| Name | Class |
|---|---|
| Hamilton Health Sciences Corporation | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vasopressor | Other | 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 |
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| Platelet | Other | 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. |
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| Nutrition | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1- Vasopressor - Mean arterial pressure 56-60 | Drug | Vasopressor(s) will be titrated according to 56-60 range. |
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| Measure | Description | Time Frame |
|---|---|---|
| Vasopressor Domain - Composite endpoint | Incorporate mortality, persistent organ dysfunction (POD) in the intensive care unit (ICU), days in hospital, and disposition at hospital discharge. | At hospital discharge up to day 30 |
| Platelet Domain - All cause mortality | 90-day all-cause mortality | 90 days |
| Nutrition Domain - Recruitment rate | Recruitment rate of 2 patients per site per month. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU. |
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VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.
Inclusion criteria:
Exclusion criteria:
PLATELET DOMAIN
Inclusion criteria:
Exclusion criteria:
NUTRITION DOMAIN
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Helene Masse, RRT, MSc | Contact | 1-819-346-1110 | 14173 | marie-helene.masse3@usherbrooke.ca |
| Name | Affiliation | Role |
|---|---|---|
| Francois Lamontagne, MD, MSc | Université de Sherbrooke | Principal Investigator |
| Neill Adhikari, MDCM, MSc | Sunnybrook Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences - Juravinski Hospital | Recruiting | Hamilton | Ontario | L8V 1C3 | Canada |
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| Label | URL |
|---|---|
| Website of the CEPEC trial | View source |
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Adaptive Bayesian Platform trial evaluating multiple interventions in multiple domains.
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| 2- Vasopressor - Mean arterial pressure 61-65 | Drug | Vasopressor(s) will be titrated according to 61-65 range. |
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| 3- Vasopressor - Mean arterial pressure 66-70 | Drug | Vasopressor(s) will be titrated according to 66-70 range. |
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| 4- Vasopressor - Mean arterial pressure 71-75 | Drug | Vasopressor(s) will be titrated according to 71-75 range. |
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| 1- Platelet less than 10 x 109/L | Other | 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. |
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| 2- Platelet less than 20 x 109/L | Other | 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. |
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| 3- Platelet less than 30 x 109/L | Other | 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. |
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| 4- Platelet less than 40 x 109/L | Other | 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. |
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| 5- Platelet less than 50 x 109/L | Other | 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. |
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| Enteral nutrition - Boluses | Other | Given 3 times a day. |
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| Enteral nutrition - Continuous | Other | Given over 24-hour period |
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| At hospital discharge up to day 30 |
| Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU | POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU. | Up to day 30 |
| Vasopressor, Platelet and Nutrition Domains - Disposition at hospital discharge | Increased level of care as indicated by change of address vs. return to baseline [previous home address] | At hospital discharge up to day 30 |
| Vasopressor, Platelet and Nutrition Domains - Number of days without POD in the ICU | POD is defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy whilst in ICU. | At hospital discharge up to day 30 |
| 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 | Transfusion-associated circulatory overload, transfusion-related acute lung injury, infections, anaphylaxis | During hospitalization |
| 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 | Evaluated using EQ-5D-5L questionnaire | 90 days |
| Nutrition Domain - Diarrhea | Defined by the World Health Organization (WHO) definition (3 or greater liquids stools/24 hours) | 24 hours |
| Nutition Domain - Percentage of target nutritional intake | >80% | Over the course of the ICU stay up to day 30 |
| Nutrition Domain - Vomiting | Vomiting 2 or more times in a 24-hour period | During ICU stay up to day 30 |
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| Scarborough Health Network | Recruiting | Scarborough Village | Ontario | M1P 2V5 | Canada |
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| Niagara Health | Recruiting | St. Catharines | Ontario | L2S 0A9 | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| Centre hospitalier de l'Université de Montréal (CHUM) | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
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| CIUSSS de l'Estrie - CHUS | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| Auckland City Hospital | Not yet recruiting | Auckland | New Zealand |
| Intensive Care National Audit and Research Centre (coordinating centre for sites in UK. Sites to be determined) | Not yet recruiting | London | United Kingdom |