Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock (PROMIX)

Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock: a French Multicenter Cohort

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Myocardial Infarction (MI); Mechanical Circulatory Support; Bypass, Cardiopulmonary; Cardiogenic Shock Post Myocardial Infarction; Cardiogenic Shock Acute

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Christophe Beyls, MD, PhD; Phone Number: + 33 322087866; Email: beyls.christophe@chu-amiens.fr

Study Locations

• France
  • Somme
    • Amiens, Somme, France, 80000
      • Recruiting
      • CHU Amiens Picardie
      • Contact: Christophe Beyls; Phone Number: 0322087866; Email: beyls.christophe59@gmail.com
      • Sub-Investigator: Pierre Grégoire Guinot, MD, Phd
      • Sub-Investigator: Emmanuel Besnier, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with Mixed Cardiogenic-Vasoplegia Shock; Patients hospitalized in an intensive care unit (ICU) or cardiac ICU for cardiogenic shock, at least stage C according to the SCAI classification. Vasoplegia was defined by the requirement of norepinephrine > 0.20 µg/kg/min (γ/kg/min) to maintain a mean arterial pressure ≥ 65 mmHg.
Patients with Cardiogenick Shock Without Vasoplegia; Patients hospitalized in an intensive care unit (ICU) or cardiac ICU for cardiogenic shock, at least stage C according to the SCAI classification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 90 days	documented death occurring within 90 days following ICU admission	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days
Phenotyping Cardiogenic Shock by Clustering	Identification of subgroups using unsupervised classification methods (clustering) and comparison of 90-day mortality rates.	90 days
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.	90 days
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)	7 days
Evolution of Norepinephrine Equivalent (NEE) Requirement	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.	7 days
Evolution of Vasopressor Requirement	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.	7 days
Clinical outcomes	Use of renal replacement therapy and mechanical circulatory support (VA-ECMO, Impella, intra-aortic balloon pump).	90 days
ICU length of stay	Duration of ICU length of stay (days) since the ICU admission	90 days
Hospital lenght of stay	Duration of the Hospital lenght of stay (days) since the hospital admission and home discharge.	90 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Rouen; Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cardiogenic Shock; Vasopressor; Mechanical Circulatory Support; VA-ECMO; Mixed Cardiogenic Shock; post cardiotomy shock
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Shock, Cardiogenic; Shock, Septic; Myocardial Infarction
• Other Study ID Numbers: PI2025_843_0187; N° HDH : 27130053 (Other Identifier: Health Data Hub)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No