Analysis of Laboratory Markers for Severe COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Biochemical markers' correlation with outcomes
研究概览
简要总结
The course of coronavirus infection was often severe and required hospitalization of patients in the intensive care unit. The new SARS-Cov-2 has been poor studied, so relatively reliable markers are needed to effectively monitor patients and predict complications and outcome. Taking into account the known mechanisms of pathogenesis, the biochemical markers as ferritin, procalcitonin, C-reactive protein and D-dimer were chosen for this purpose. Patients were divided according to the degree of pulmonary infiltration. We hypothesized that the markers would correlate with dynamics, complications, and outcomes.
详细描述
In the presented study, an analysis of the medical records of 193 patients hospitalized in severe condition to the intensive care unit with a confirmed diagnosis of Coronavirus infection COVID-19 was carried out. Taking into account the volume of pulmonary infiltration according to computer tomography (CT) of the chest organs, patients were divided into 4 groups in accordance with the approved classification: CT 1(up to 25% of lung tissue was infiltrated) - 27 patients, CT 2 (25-50%) - 60 patients, CT 3 (50-75%) - 67 patients, CT 4 (75% and more) - 39 patients. The following biochemical parameters were selected and used to monitor dynamics: procalcitonin (PCT), C-reactive protein (CRP), D-dimer (DD), ferritin (FRT). The duration of observation was 15 days.
In order to determine correlations between quantitative and qualitative data at different stages of treatment, a correlation analysis was carried out (Spearman's test was used). ROC analysis was performed to evaluate selected laboratory markers as predictors of outcome. Next, the odds ratio (OR) was assessed taking into account the obtained Youden's J index and the Associated criterion for each of the selected markers in relation to the patient's outcome. Preliminary contingency tables were compiled in relation to laboratory parameters and outcomes (2x2 tables).
Data were processed using statistical software jamovi (Computer Software ,Version 2.3.26), MedCalc (MedCalc Software Ltd, Ostend, Belgium), Microsoft Office Excel, 2016.
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
- 否
入选标准
- •identified COVID-19 by nasopharyngeal material PCR, coronavirus associated lung infiltration, visualized by CT, and clinically severe condition
排除标准
- •pregnancy
结局指标
主要结局
Biochemical markers' correlation with outcomes
时间窗: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
In the early stages of hospitalization was found the significant inverse correlation (p \< 0.01, r -0.236) with the outcome of the stay for procalcitonin levels on the third day - larger concentrations of this marker were associated with death for the patient; on day 7 - weaker inverse correlation (p \< 0.05, r -0.246), by the end of treatment - a significant inverse correlation at p \< 0.001, r -0.393. A correlation between D-dimer and the outcome of the stay was revealed - on the 3rd day and at the end of treatment - in both cases the correlation is inverse, quite significant (p \< 0.01, r-0.237and p \< 0.001, r-0.512 respectively). Higher ferritin levels correlated with death when determined in the late period of hospitalization - inverse correlation at p \< 0.001, r-0.447.
Markers as outcome predictors
时间窗: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
According to the results of ROC analysis predictively significant for mortal outcome (\*AUC values are close to 1.0, at the significance level P =0.05) were: procalcitonin level on days 3, 7 and 15, CRP level on days 7 and 15, levels of D-dimer on days 3, 7 and 15, ferritin on days 3 and 7
次要结局
- the correlation between the level of biomarkers and the degree of infiltration of lung tissue(Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.)
- The level of D-dimer quite significantly negatively correlated with the duration of stay in the intensive care unit(Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.)
- The inverse correlation was found for procalcitonin and the patient-bed-days in the intensive care unit(Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.)