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临床试验/NCT04371679
NCT04371679Unknown不适用

Changes in Cardiac and Pulmonary Hemodynamics as Predictor of Outcome in Hospitalized COVID-19 Patients

Hasselt University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Death (all-cause mortality) or discharge from ICU (limit of 4 months)

研究概览

简要总结

The primary objective of the study is to evaluate cardiac and pulmonary hemodynamic changes over time as predictor of disease progression and outcome in COVID-19 patients admitted to ICU.

The primary endpoint is the occurrence of a major event predefined as either: death (all-cause mortality) or discharge from ICU (limit of 4 months).

This is a uni-center prospective observational cohort study with an inclusion period of 2 months. The end of the study is foreseen in 6 months.

详细描述

Background COVID-19 can lead to a bilateral pneumonia overwhelming the lungs causing dyspnea and respiratory distress. Up to 20% of the infected population is hospitalized and 5% is submitted to the intensive care unit (ICU). Up to 31% of patients in ICU develop sepsis and 61% develop ARDS with a deadly outcome at ICU of 38%. While sepsis typically causes diffuse vasodilation, the pulmonary vasculature resistance in ARDS is high. Although heart failure is per definition not the cause of ARDS, the resulting elevated pressures in the pulmonary circulation affect right and left heart function. Early detection in alterations of cardiac and pulmonary hemodynamics might prompt to actions to prevent ARDS.

Primary objective To evaluate cardiac and pulmonary hemodynamic changes over time as predictor of disease progression and outcome in COVID-19 patients admitted to ICU.

Secondary objective

  • Analysis of prognostic factors based on the data at initial presentation
  • Performing a trajectory analysis of the time course during ICU stay to determine what leads to optimal outcome - gain insight in the pathophysiology of the cardio-pulmonary evolution of COVID-19 pts
  • Feasibility study for the creation of an individualized expected data-trajectory for new cases and continuously updating its visualization in relation to the expected trajectory related to an improved outcome
  • Evaluate how Machine Learning, based on manifold learning for quantifying information similarity and its temporal evolution, is able to predict outcome using rich data in a limited number of patients Primary Endpoint

Occurrence of a major event predefined as either:

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient admitted to ICU that is COVID-19 positive based on rt-PCR
  • Ventilated or not ventilated
  • No restrictions on age
  • No restrictions on comorbidities or a diversity of underlying pathology (malignancies, COPD, ...)

排除标准

  • Patients that are not COVID-19 tested (rt-PCR) or where the diagnosis is pending.
  • Patients that refuse their participation in the study.
  • Patients under legal protection, or deprived of their liberty.
  • Patients that are so critically ill that a minimum of 1 follow-up is very unlikely to be realised

结局指标

主要结局

Death (all-cause mortality) or discharge from ICU (limit of 4 months)

时间窗: 4 months

Covid-19 pneumonia that requires ICU admission can go either way.

次要结局

未报告次要终点

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. dr. Paul Dendale

Head of Cardiology

Hasselt University

研究点 (1)

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