跳至主要内容
临床试验/NCT04457817
NCT04457817终止不适用

CRI and Continuous Assessment of Hemodynamic Compensation to Guide Fluid and Pressor Management in Severely Ill Patients With COVID-19

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
1
主要终点
Number of Patients with Acute Kidney Injury (AKI)

研究概览

简要总结

The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label.

The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research has been done since the FDA determination to further support the use of the device outside of its current labeling.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible patients will be those who are:
  • COVID-19 positive;
  • Ages > 18 and < 70 years old;
  • Require > 2 liters of oxygen by nasal cannula to maintain SpO2 > 90%;
  • Are admitted to the sixth floor at University Hospital, on one of two designated Hospitalist services (approximately 16 COVID-19 positive patients/service).

排除标准

  • COVID-19 negative
  • Age <18 or >70 years
  • On <2 liters oxygen via nasal canula
  • Incarcerated
  • Decisionally Challenged

结局指标

主要结局

Number of Patients with Acute Kidney Injury (AKI)

时间窗: 1 year

Number of patients who acquire an acute kidney injury

FiO2 needs

时间窗: 1 year

FiO2 levels administered

mortality

时间窗: 1 year

Number of patients who experience mortality

Volume of IV fluid infused

时间窗: 1 year

Volume of IV fluid infused during treatment

Days on Oxygen

时间窗: 1 year

Days spent on oxygen

Quantity of Blood pressure medication administered

时间窗: 1 year

Amount of blood pressure medication utilized during treatment

Resuscitation status

时间窗: 1 year

Categorical determination of resuscitation status as over- or under- resuscitated

Number of participants with hospital acquired pneumonia

时间窗: 1 year

Number of participants with hospital acquired pneumonia

Number of patients with hemodynamic collapse

时间窗: 1 year

Number of patients who experience hemodynamic collapse defined as drop in systolic blood pressure below 80mm Hg

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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