Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

2,500 Participants
are grouped into 2 trial groups
Group A: Patients with Mixed Cardiogenic-Vasoplegia Shock
Group B: Patients with Cardiogenick Shock Without Vasoplegia

Trial outcomes

Primary outcomes

1

All-cause mortality at 90 days

documented death occurring within 90 days following ICU admission

Time frame
90 days

Secondary outcomes

1

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.

Time frame
90 days
2

Phenotyping Cardiogenic Shock by Clustering

Identification of subgroups using unsupervised classification methods (clustering) and comparison of 90-day mortality rates.

Time frame
90 days
3

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.

Time frame
90 days
4

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)

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

Centre Hospitalier Universitaire Dijon

Collaborator

University Hospital, Rouen

Collaborator