Bypass, Cardiopulmonary, Cardiogenic Shock Acute, Cardiogenic Shock Post Myocardial Infarction, Mechanical Circulatory Support, Myocardial Infarction (MI), Septic Shock
Conditions
Keywords
VA-ECMO, Cardiogenic Shock, Mechanical Circulatory Support, Vasopressor, Mixed Cardiogenic Shock, post cardiotomy shock
Brief 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.
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire Dijon
University Hospital, Rouen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality at 90 days | 90 days | documented death occurring within 90 days following ICU admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | 90 days | Duration of ICU length of stay (days) since the ICU admission |
| Evolution of Vasopressor Requirement | 7 days | To assess the dynamic evolution of vasopressor and inotropic support quantified using the Vasopressor-Inotropic Score (VIS). VIS is calculated as a composite score based on standardized doses of vasopressors and inotropes, with higher scores indicating greater vasopressor and inotropic support (worse hemodynamic severity). VIS values will be assessed at predefined time points Day 0, Day 1, Day 3, Day 5, and Day 7 after shock onset. |
| Clinical characteristics and management trajectories | 90 days | 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 | 90 days | Identification of subgroups using unsupervised classification methods (clustering) and comparison of 90-day mortality rates. |
| Evolution of the SCAI Classification | 90 days | 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 | 7 days | To assess the dynamic evolution of systolic, diastolic, and mean blood pressure (in mmHg) from Day 0 (D0) to Day 7 (D7) |
| Evolution of Norepinephrine Equivalent (NEE) Requirement | 7 days | NEE (expressed in µg/kg/min) will be calculated at predefined time points: D0, D1, D3, D5, and D7, using standardized conversion factors to express all vasopressor doses as norepinephrine equivalents. |
| Clinical outcomes | 90 days | Use of renal replacement therapy and mechanical circulatory support (VA-ECMO, Impella, intra-aortic balloon pump). |
| Hospital lenght of stay | 90 days | Duration of the Hospital lenght of stay (days) since the hospital admission and home discharge. |
Countries
France
Contacts
CONTACTChristophe Beyls, MD, PhD
Outcome results
None listed