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Recruiting NCT07354568

Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock

Observational Cardiogenic Shock Acute Bypass, Cardiopulmonary Septic Shock Mechanical Circulatory Support

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiogenic Shock Acute, Bypass, Cardiopulmonary, Septic Shock, Mechanical Circulatory Support. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • All-cause mortality at 90 days [Time frame: 90 days]
Secondary outcome measures (9)
  • Clinical characteristics and management trajectories [Time frame: 90 days]
  • Phenotyping Cardiogenic Shock by Clustering [Time frame: 90 days]
  • Evolution of the SCAI Classification [Time frame: 90 days]
  • Evolution of Arterial Pressure [Time frame: 7 days]
  • Evolution of Norepinephrine Equivalent (NEE) Requirement [Time frame: 7 days]
  • Evolution of Vasopressor Requirement [Time frame: 7 days]
  • Clinical outcomes [Time frame: 90 days]
  • ICU length of stay [Time frame: 90 days]
  • Hospital lenght of stay [Time frame: 90 days]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU Amiens Picardie — Amiens

Identifiers

NCT: NCT07354568 · PI2025_843_0187 · N° HDH : 27130053

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗