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临床试验/NCT05083013
NCT05083013Unknown不适用

Outcomes of Diabetes In Hospitalized COVID-19 Patients At Assiut University Hospital

Assiut University0 个研究点目标入组 160 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
主要终点
Mortality rates

研究概览

简要总结

Coronavirus disease (COVID-19), a global pandemic affecting the whole world and taking the lives of millions. The majority of fatalities occur in the elderly specially in the presence of chronic diseases such as diabetes mellitus (DM), hypertension, obesity, cardiovascular disease, chronic kidney disease and cancer.

详细描述

Knowing about the family of coronaviruses is that they are the cause of a variety of well-known diseases affecting humans, ranging from common cold to the Middle East Respiratory Syndrome (MERS) and Acute Severe Respiratory Syndrome (SARS), and now the COVID-19 as a new problematic family member.

Regarding DM as a knowing old health problem, it has been found that we can use it in predicting the prognosis of the COVID-19 as admission to intensive care unit, invasive ventilation or even death.

Previous studies confirmed that uncontrolled DM can badly affects innate immunity which considered as the first line of defence mechanism against COVID-19 infection.

In addition, DM has a pro-inflammatory effect through exaggeration of cytokine response which appears clearly through higher results of serum levels of interleukin-6 (IL-6), C-reactive protein and ferritin, this suggests that people with DM are more venerable to cytokine storm which leads to Acute Respiratory Distress Syndrome (ARDS), shock and rapid deterioration of the case.

On the other hand, on looking to previous studies and data collected about the prior SARS outbreak in 2003, which suggested that COVID-19 can lead to worsening of glycemic control in known diabetic patients and above that caused by the stressful nature of a critical illness.

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

  • Cases aged 18 years and over.
  • Cases diagnosed as COVID-19 positive.
  • Cases admitted to Assiut University Hospitals.

排除标准

  • Age less than 18 years.
  • Outpatient management (even in confirmed cases of COVID-19).

结局指标

主要结局

Mortality rates

时间窗: up to 1 year

mortality rate among diabetic and non diabetic COVID-19 patients

Need for ICU admission

时间窗: up to 1 year

who will need ICU admission during patient hospitalization

Hospital stays

时间窗: up to 1 year

for how long patients admitted to hospital

Need for ventilatory support

时间窗: up to 1 year

who will need for ventilatory support (Non-Invasive ventilation (NIV), High Flow Nasal Cannula (HFNC) and Invasive Mechanical Ventilation (IMV).

次要结局

  • Exacerbation of chronic complications of diabetes(up to 1 year)
  • Incidence of other complications(up to 1 year)
  • Glycemic control(up to 1 year)
  • Newly onset DM will appear among non-diabetic patients(up to 1 year)
  • Acute complications of diabetes(up to 1 year)
  • Changes of diabetes management plan(up to 1 year)

研究者

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

Martina Saad Lamey

Principal Investigator

Assiut University

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