About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient (>18 years old)
Admitted to an intensive care unit for cardiogenic shock, at least SCAI stage C
No opposition to data use
Disqualifiers
Missing key data, particularly regarding vasopressor doses and outcomes.
Pregnant women
Anaphylactic shock,
Isolated hemorrhagic shock,
Trial population
The study will include adult patients (\>18 years old) admitted to an intensive care unit for mixed cardiogenic shock (M-CS), defined by the coexistence of low cardiac output and, when present, vasoplegia requiring vasopressor support (norepinephrine \>0.15 µg/kg/min) despite adequate filling pressures. Eligible patients must meet at least SCAI stage B criteria for cardiogenic shock. Patients with major missing data, particularly on vasopressor dosing, or those who have expressed opposition to data use will be excluded. This population represents a heterogeneous, high-risk group combining features of cardiogenic and vasoplegic circulatory failure, including ischemic, post-cardiotomy, and septic cardiomyopathy etiologies. The PROMIX study aims to better characterize clinical trajectories, hemodynamic profiles, and outcomes of these patients through clustering and phenotypic analyses.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
All-cause mortality at 90 days
documented death occurring within 90 days following ICU admission
Secondary outcomes
Clinical characteristics and management trajectories
This outcome is descriptive in nature and aims to characterize the study population. Baseline variables (e.g., age, sex, cardiovascular history, comorbidities, and etiology of shock) will be reported separately using appropriate units for each variable (e.g., years, proportions, or categories), without aggregation into a single summary measure.
Phenotyping Cardiogenic Shock by Clustering
Identification of subgroups using unsupervised classification methods (clustering) and comparison of 90-day mortality rates.
Evolution of the SCAI Classification
Dynamic Evolution of the SCAI Classification (A to E) during the ICU stay. Each stage of classification is recording each day and during all ICU stay.
Evolution of Arterial Pressure
To assess the dynamic evolution of systolic, diastolic, and mean blood pressure (in mmHg) from Day 0 (D0) to Day 7 (D7)
Sponsors and contacts
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Centre Hospitalier Universitaire, Amiens
Lead sponsor
Centre Hospitalier Universitaire Dijon
Collaborator
University Hospital, Rouen
Collaborator