Study of MDW Levels Predicting the Development of Sepsis in Hospitalized HIV-infected Patients and Correlation With Prognosis
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Number of deaths of enrolled patients
研究概览
简要总结
Sepsis is a common and critical complication in HIV-infected patients and an important marker of high risk of patient death. The widely used diagnostic criteria for sepsis still have many deficiencies and do not allow for good prediction and timely determination of the onset of sepsis. In HIV-infected patients, abnormal activation of monocyte-macrophage is also a key mechanism in the development of their sepsis. Monocyte distribution width (MDW) is a marker of the degree of peripheral blood monocyte activation and has been recommended abroad for the early diagnosis of adult sepsis patients in emergency departments. However, in China, MDW has not been applied to the clinic yet, and the related studies are almost blank. Therefore, it is worthwhile to analyze the monocyte activation status of HIV-infected patients by MDW assay and thus predict the occurrence of sepsis.
详细描述
This is a prospective observational study, and investigators intend to collect HIV-infected patients in our hospital within 1 year from the conduct of this study and hospitalized, after informed consent, for inclusion in the study. Investigators will collect clinical data, basic laboratory indicators, and test MDW levels of the patients and follow the patients until discharge or death.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive ELISA test results for HIV-1 antibodies;
- •Hospitalized patients; Voluntarily signing the patient's informed consent and being able to promise to be followed up;
- •No plans to move away from the current trial site during the course of the trial.
排除标准
- •Western Blot and/or HIV RNA assay confirmed as HIV negative;
- •Women who are pregnant or breastfeeding;
- •Current drug users;
- •Persons with a history of alcohol abuse that cannot be terminated;
- •Persons of non-Chinese nationality;
- •Other patients who, in the judgment of the investigator, are deemed unsuitable for participation in this trial.
结局指标
主要结局
Number of deaths of enrolled patients
时间窗: within 28 days
In HIV infection with sepsis, whether higher MDW score is related to poor prognosis.
Number of participants with sepsis of admission
时间窗: within 28 days
Using Sepsis 3.0 as the diagnostic criteria, the sensitivity and specificity of using MDW to diagnose sepsis in HIV-infected patients.
次要结局
未报告次要终点
研究者
Jun Chen, MD
Deputy Director of Department of Infectious Diseases and Immunology
Shanghai Public Health Clinical Center