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临床试验/NCT07354568
NCT07354568招募中不适用

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

Centre Hospitalier Universitaire, Amiens0 个研究点目标入组 2,500 人开始时间: 2025年10月20日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
2,500

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient (>18 years old)
  • Admitted to an intensive care unit for cardiogenic shock, at least SCAI stage C
  • No opposition to data use

排除标准

  • 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).

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beyls

Doctor, Principal Investigator

Centre Hospitalier Universitaire, Amiens

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