Study of MDW Levels Predicting the Development of Sepsis in Hospitalized HIV-infected Patients and Correlation With Prognosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of MDW Levels Predicting the Development of Sepsis in Hospitalized HIV-infected Patients and Correlation With Prognosis

Conditions
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HIV Infections, Sepsis

Intervention / Treatment
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* Diagnostic Test: Monocyte distribution width (MDW）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV infection group<br> | Diagnostic Test: Monocyte distribution width (MDW）<br>* All enrolled patients will receive test with MDW.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with sepsis of admission | Using Sepsis 3.0 as the diagnostic criteria, the sensitivity and specificity of using MDW to diagnose sepsis in HIV-infected patients. | within 28 days | 
| Number of deaths of enrolled patients | In HIV infection with sepsis, whether higher MDW score is related to poor prognosis. | within 28 days |