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Tests treatment safety and results for Intensive Care Unit ICU
Official title Canadian Critical Care Comparative Effectiveness Platform
ClinicalTrials.gov ID: NCT06605144
What this study is testing
What is 1- Vasopressor - Mean arterial pressure 56-60?
1- Vasopressor - Mean arterial pressure 56-60 is an investigational medicine, given as an once-daily, being studied as a potential treatment for intensive care unit icu.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.
- 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.
You likely can't join if
- 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);
See the full eligibility criteria
- VASOPRESSOR DOMAIN There is no minimum age limit in the Vasopressor Domain.
- 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.
- 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 assigned by chance 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 assigned by chance 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
- Scarborough Village, Ontario, Canada
- St. Catharines, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Auckland, New Zealand
- London, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Scarborough Village, Ontario, Canada; St. Catharines, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.