Health Sciences University Bursa Yüksek Ihtisas Training and Research Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- prognosis
研究概览
简要总结
Aim:There is still not enough data to determine methylprednisolone treatment timing, dosage, duration of use and indication in Covid 19 pneumonia. The aim of this study is to examine the relationship between drug dose and hospitalisation time and mortality rates in patients with pre-diagnosis of severe covid pneumonia and systemic methylprednisolone.
Materials and Methods: The demographic data, symptom durations, thorax CT findings, methylprednisolone dose and duration of treatment, hospitalisation times, intensive care hospitalizations of the patients who were initiated and hospitalized in the emergency department will be retrospectively recorded. Finally, the fate of the patients (such as discharge, referral, death) will be recorded.Statistical analysis will be conducted using the Statistical Package for Social Sciences (SPSS) (IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) program.
详细描述
Covid 19 infection can progress with widespread inflammation and cytokine storm. Induced excessive cytokine release is associated with tissue damage in the lung. Severe inflammatory / oxidative stress response and severe lung injury secondary to ARDS may develop. Therefore, suppressing the proinflammatory response has a very important place in treatment. Methylprednisolone is classically an immune response suppressor, powerful anti-inflammatory drug and is used in the treatment of covid 19 severe infection. However, there is still not enough data to determine the treatment timing, dosage, duration of use and indication.
The aim of this study is to examine the relationship between drug dose and hospitalisation time and mortality rates in patients with pre-diagnosis of severe covid pneumonia and systemic methylprednisolone.
Materials and Methods
The demographic data, symptom durations, thorax CT findings, methylprednisolone dose and duration of treatment, hospitalisation times, intensive care hospitalisations of the patients who were initiated and hospitalized in the emergency department will be retrospectively recorded. Finally, the fate of the patients (such as discharge, referral, death) will be recorded.
In the treatment of severe Covid 19 pneumonia, methylprednisolone treatment is used in addition to antiviral treatment. However, there are insufficient data on the time to start this treatment, drug dose and duration of use in daily routine. With the results of our study, we hope that we can contribute to the dose, duration and timing of methylprednisolone use in the treatment of Covid 19 pneumonia.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Patients older than 18 years of age who presented to our hospital's emergency clinic
- •Patients with pre-diagnosis of severe covid pneumonia
- •Patients starting methylprednisolone therapy.
排除标准
- •<18 years
- •Patients with a pre-diagnosis of mild or moderate Covid 19 pneumonia
- •Patients not hospitalized in our hospital
- •Pregnant patients with Covid 19 pneumonia
- •Patients whose 5-methylprednisolone treatment was started in the emergency and discontinued in less than 3 days
研究组 & 干预措施
Group 1
Patients who are started on 1 mg/kg/day methylprednisolone. Demographic data of the patients, length of hospital stay, follow-up in intensive care unit and prognosis will be recorded.
干预措施: methylprednisolone (Drug)
Group 2
Patients who are started on 250 mg/day methylprednisolone. Demographic data of the patients, length of hospital stay, follow-up in intensive care unit and prognosis will be recorded.
干预措施: methylprednisolone (Drug)
结局指标
主要结局
prognosis
时间窗: died during hospitalisation
The patient was died.
hospitalization time
时间窗: days between hospitalisation and externalization or death
Time elapsed after the patient is hospitalized until person is discharged or died.
次要结局
未报告次要终点
研究者
Seyhan Dülger,MD
Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital
Bursa Yüksek İhtisas Education and Research Hospital