跳至主要内容
临床试验/CTRI/2020/12/029586
CTRI/2020/12/029586尚未招募不适用

Assessment of predictors of severity inCOVID 19 patients admitted to intensive care unit of a tertiary care hospital

jss medical college1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
To assess the predictors of severity in COVID 19 patients admitted in Intensive care unit by analyzing the haematological and biochemical parameters.

研究概览

简要总结

Brief resume of intended work:

A novel human coronavirus, first detected during an unexplained cluster of pneumonia cases in Wuhan, China in December 2019 has caused a global outbreak and has become a major public health problem worldwide. The World Health Organization (WHO) officially named this new coronavirus disease as COVID 19 and the virus causing it as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). WHO also declared COVID 19 as pandemic on March 21, 2020. According to WHO website as of August 28th, 2020, around 2,42,99,923 confirmed cases and 8,27,730  deaths have been reported from across the worldand  in India COVID 19  is around 3,94,513 confirmed cases and 62,669 deaths 1.  COVID 19 patient’s presents from mild symptoms of upper respiratory tract infection to severe respiratory failure. 80-85% of patients are asymptomatic or have self-limiting disease and remaining have severe disease.  Many COVID 19 individuals have died due to complications from some of the main risk factors for COVID 19 such as ARDS, pneumonia, coagulopathy, acute kidney failure, acute heart failure etc which is likely attributable to uncontrolled acute inflammation and cytokine storm2.  Clinical data obtained from COVID-19 patients in China reported high concentrations of cytokines in patients admitted to the ICU, which indicates the presence of cytokine storm in severe COVID-19 cases3. So it is important to know the levels of inflammatory markers to identify patients at high risk for severe COVID-19 and mortality.

Human observational studies have frequently reported that higher vitamin D levels were associated with lower inflammatory markers including CRP, IL-6 and TNFα in healthy populations, and in those with proinflammatory conditions, such as diabetes, arteriosclerosis and inflammatory polyarthritis4. A cross-sectional analysis across Europe showed that COVID 19 mortality was significantly associated with vitamin D status in different populations and that vitamin D status was strongly associated with Covid-19 mortality 5.

As the COVID 19 pandemic continues to increase and currently no effective vaccines or specific drugs against COVID 19 have been reported, the need to understand the predictors of severe COVID 19 is becoming important, so that early identification of severity and prognosis of COVID-19 enables early intervention for the reduction of mortality risk.  Hence we hypothesize that, haematological and biochemical markers in COVID 19 infection positive persons would be significantly associated with mortality and morbidity and vitamin D deficiency is associated with COVID 19.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
Male

入选标准

  • Patients with COVID 19 infection admitted in ICU.

排除标准

  • Patients not willing to give consent for the study.

结局指标

主要结局

To assess the predictors of severity in COVID 19 patients admitted in Intensive care unit by analyzing the haematological and biochemical parameters.

时间窗: on admission and every second day

次要结局

  • To determine the association of vitamin D deficiency with the risk COVID–19 infection.(on admission)

研究者

申办方类型
Private medical college

研究点 (1)

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