Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock

NCT07354568 | Recruiting

• 2 other identifiers: PI2025_843_0187N° HDH : 27130053
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Cardiogenic Shock Acute; Bypass, Cardiopulmonary; Myocardial Infarction (MI); Mechanical Circulatory Support; Cardiogenic Shock Post Myocardial Infarction

Keywords

VA-ECMO; Cardiogenic Shock; Mechanical Circulatory Support; Vasopressor; Mixed Cardiogenic Shock; post cardiotomy shock

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at 90 days

  documented death occurring within 90 days following ICU admission

  90 days

Secondary Outcomes (9)

• Clinical characteristics and management trajectories

  90 days

• Phenotyping Cardiogenic Shock by Clustering

  90 days

• Evolution of the SCAI Classification

  90 days

• Evolution of Arterial Pressure

  7 days

• Evolution of Norepinephrine Equivalent (NEE) Requirement

  7 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patient (\>18 years old)
• Admitted to an intensive care unit for cardiogenic shock, at least SCAI stage C
• No opposition to data use

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Centre Hospitalier Universitaire Dijon: collaborator
• University Hospital, Rouen: collaborator

Study Sites (1)

CHU Amiens Picardie

Amiens, Somme, 80000, France

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Myocardial Infarction; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis

Central Study Contacts

Christophe Beyls, MD, PhD

CONTACT

+ 33 322087866; beyls.christophe@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Principal Investigator

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 21, 2026
• Study Start: October 20, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)