跳至主要内容
临床试验/NCT04873388
NCT04873388Enrolling By Invitation不适用

Biomarkers and Early Predictors of Prognostic Course, Response to Possible to Possible Treatments and Risk of Over-infection in Patients With COVID-19 Hospitalized in the Critical or Semi-intensive Area.

University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
150
试验地点
1
主要终点
ICU inpatient length of stay

研究概览

简要总结

Although the recent literature is building a remarkable background to answer the many unknowns related to SARS-CoV-2 infection, it is absolutely necessary to finalize every clinical effort to collect data that may be useful, in a short time, to improve our knowledge of SARS-CoV-2 infection. Numerous biomarkers have been evaluated in the recent literature as being altered in patients with severe forms of COVID-19. Particularly, in the critical care area, the research of early predictors of mortality is essential for high-flow management of patients requiring invasive assisted ventilation and requiring invasive and non-invasive assisted ventilation, hemodynamic support, sometimes extracorporeal support (Extracorporeal Membrane Oxygenation, ECMO). The coordinated study of different biomarkers, in particular, if combined with each other, possibly even to constitute a possible score, could guide the correct allocation of patients between hospital departments and the appropriate management in intensive care units. appropriate management in intensive care units, as well as providing an early prognostic indication. prognostic indication. The combination of these biomarkers with routine clinical and laboratory data may further provide valuable information about their use in acute care and as progressive acute and as progressive monitoring over time.

Regarding the data of interest on the clinical trend, the evaluation of the respiratory support modalities, from the administration of oxygen therapy (by nasal cannulae or Venturi mask, or by high flow system - High Flow Nasal Cannula, HFNC), to CPAP support or by non-invasive or invasive ventilation, appears of particular importance.

Therefore, the present study will be conducted in sub-intensive as well as intensive care units, in order to evaluate different types of patients, and their possible evolution over time.

The comparison between the populations belonging to different areas of intensity of care will be able to describe the different populations. Data analysis will allow an evaluation of possible risk factors and prognostic determinants of the severity of the disease and its infectious complications.

研究设计

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

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

  • hospitalized patients with clinical signs and symptoms of COVID-19, confirmed by nasopharyngeal swab RT-PCR of airways positive for SARS-CoV-2
  • age > 18 years
  • Hospitalization in the departments of the hospitals involved

排除标准

  • 未提供

结局指标

主要结局

ICU inpatient length of stay

时间窗: 24 months

ICU inpatient mortality

时间窗: 24 months

次要结局

  • Incidence of over-infections (bacterial, viral, fungal), particularly of bacteremia and pneumonias associated with mechanical ventilation; observed infections' microbiological characteristics.(24 months)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Sponsor

研究点 (1)

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