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RecruitingNCT07354568

Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
2,500 (estimated)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2025-10-20
Primary completion
2027-01-01
Completion
2027-06-01
First posted
2026-01-21
Last updated
2026-01-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07354568. Inclusion in this directory is not an endorsement.