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临床试验/NCT04422535
NCT04422535Unknown不适用

Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients

Matilde Zaballos1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年5月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection

研究概览

简要总结

The present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.

详细描述

Coronavirus infection of Severe Acute Respiratory Syndrome COVID-2 is characterized by a broad clinical spectrum ranging from asymptomatic infection, mild upper respiratory tract disease and severe viral pneumonia with respiratory failure and even death, with many patients hospitalized with pneumonia. In addition, the infection can have a direct impact on cardiovascular disease including the development of arrhythmias, although the exact incidence is not known. Treatments administered for COVID-19 infection have the potential to produce adverse cardiovascular effects including prolongation of the QT interval and development of arrhythmias.

Relevant clinical data that may affect the QT interval and specifically the medication the patient has received will be recorded. The specific treatment administered for COVID-19 will be recorded as the concomitant medication of the critical patient that may have an impact on the QT interval. Analytical data will also be collected on plasma levels of ions such as potassium, calcium and magnesium, blood gases, renal and hepatic function parameters and cardiac markers.

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

  • Patients admitted to intensive care units for COVID-19 infection with an ECG record

排除标准

  • Patients in critical care unit without COVID-19 infection

结局指标

主要结局

Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection

时间窗: through study completion, an average of 1 year

The QT interval measurement will be performed on the available 12-lead ECG from the medical record. The QT interval will be measured according to the recommendations of the scientific societies of cardiology: it is considered from the beginning of the activation of the ventricular myocardium and the end of its repolarization, which are represented in the ECG respectively by the beginning of the QRS and the end of the T wave. Ideally, the QT interval should be measured in Q-wave leads in DII and V5. An average value of 3 heart cycles (beats) should be recorded. Two researchers to control inter-observer variability will perform the measurement.

次要结局

  • incidence of arrhythmias and impact of the COVI-drugs administered on QT interval(through study completion, an average of 1 year)

研究者

发起方
Matilde Zaballos
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matilde Zaballos

specialist physician at Anesthesiology Department

Hospital General Universitario Gregorio Marañon

研究点 (1)

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