Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock (NCT07354568) | Clinical Trial Compass
RecruitingNot Applicable
Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock
France2,500 participantsStarted 2025-10-20
Plain-language summary
Mixed cardiogenic-vasoplegic shock (M-CS) represents a distinct and severe phenotype of cardiogenic shock characterized by concomitant myocardial dysfunction and inappropriate systemic vasodilation. Despite its clinical relevance, the epidemiology, management, and outcomes of M-CS remain poorly defined.
This retrospective, multicenter, observational registry aims to evaluate the clinical outcomes and prognostic factors associated with mixed cardiogenic-vasoplegic shock. The study will analyze clinical, biological, and invasive hemodynamic data routinely collected during patient management for M-CS.
All included patients will have been admitted for cardiogenic shock, with or without vasoplegia, defined by low cardiac output and, when present, decreased systemic vascular resistance despite adequate filling pressures requiring vasopressor support.
The primary objective is to describe mortality and organ failure rates, while secondary analyses will identify determinants of adverse outcomes and potential phenotypic subgroups.
The PROMIX registry will be conducted across three French university hospitals (CHU Amiens-Picardie, CHU Dijon-Bourgogne, and CHU Rouen-Normandie).
This study is non-interventional, involving only data obtained as part of routine critical care, and will provide the first multicenter overview of this complex and underrecognized form of cardiogenic shock.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patient (\>18 years old)
* Admitted to an intensive care unit for cardiogenic shock, at least SCAI stage C
* No opposition to data use
Exclusion Criteria:
* Missing key data, particularly regarding vasopressor doses and outcomes.
* Pregnant women
* Non-eligible shock etiologies, including but not limited to:
* Anaphylactic shock,
* Isolated hemorrhagic shock,
* Severe burns or major trauma,
* Severe acute pancreatitis,
* Fulminant hepatic failure,
* Neurogenic shock.
* Adult under legal protection (guardianship, curatorship, or judicial protection).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at patients with a combination of cardiogenic and vasoplegic shock — can you help me understand whether my specific type of shock fits what this trial is studying, and whether that distinction matters for my treatment plan?
2Since this is an observational study measuring 90-day all-cause mortality, does participating in this trial change anything about the actual treatment I would receive, or is it purely about tracking my outcomes?
3This trial involves conditions like mechanical circulatory support and post-heart attack cardiogenic shock — given my situation, are the treatments and monitoring I'd undergo as part of this study consistent with what you'd recommend for me anyway outside of the trial?
4Because this study is currently recruiting and appears to be in an early observational phase, what does that mean for how much is already known about outcomes in patients like me with mixed cardiogenic-vasoplegic shock, and are there existing standard-of-care guidelines you'd follow regardless?
5Are there alternative studies or standard treatment pathways you'd recommend I consider alongside or instead of this trial, given that my prognosis is being tracked over 90 days and time-sensitive decisions may need to be made quickly?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.