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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07354568

PI2025_843_0187

N° HDH : 27130053 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

2,500 participants in 2 patient groups

Patients with Mixed Cardiogenic-Vasoplegia Shock

Description:

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

Description:

Patients hospitalized in an intensive care unit (ICU) or cardiac ICU for cardiogenic shock, at least stage C according to the SCAI classification.