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

• Conditions: HIV Infections; Sepsis
• Interventions: Diagnostic Test: Monocyte distribution width (MDW）

• Registration Number: NCT05036928
• Lead Sponsor: Shanghai Public Health Clinical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-11-30
• Study Start: 2021-12
• Primary Completion: 2022-09
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV infection group	Monocyte distribution width (MDW）	-

Primary Outcome Measures

Name	Time	Method
Number of deaths of enrolled patients	within 28 days	In HIV infection with sepsis, whether higher MDW score is related to poor prognosis.
Number of participants with sepsis of admission	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.

Trial Locations

Locations (1)

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China