Ireland
--:--IST
Recruiting Observational

Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock

NCT07354568 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-10-20
Last updated
2026-01-21

Condition(s) studied

Cardiogenic Shock AcuteBypass, CardiopulmonarySeptic ShockMechanical Circulatory SupportMyocardial Infarction (MI)Cardiogenic Shock Post Myocardial Infarction

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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).

Primary outcome measure(s)

  • All-cause mortality at 90 days — 90 days
    documented death occurring within 90 days following ICU admission

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Picardie Amiens Somme Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07354568 on ClinicalTrials.gov ↗ ← All trials in France