Clinical Trial

Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock

Study acronym: PROMIX
Recruiting
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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.
Trial Details
NCT Number NCT07354568
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Collaborators: Centre Hospitalier Universitaire Dijon, University Hospital, Rouen
Conditions Cardiogenic Shock Acute, Bypass, Cardiopulmonary, Septic Shock, Mechanical Circulatory Support, Myocardial Infarction (MI), Cardiogenic Shock Post Myocardial Infarction
Enrollment 2,500 participants
Start Date 2025-10-20
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-21