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

NCT ID: NCT05036928

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-10-31

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.

Conditions

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HIV Infections Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV infection group

Monocyte distribution width (MDW）

Intervention Type DIAGNOSTIC_TEST

All enrolled patients will receive test with MDW.

Interventions

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Monocyte distribution width (MDW）

All enrolled patients will receive test with MDW.

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jun Chen, MD

Deputy Director of Department of Infectious Diseases and Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Chen, Ph.D

Role: CONTACT

Phone: 021-37990333-3222

Email: [email protected]

Tangkai Qi, Ph.D

Role: CONTACT

Phone: 021-37990333-3222

Email: [email protected]

Facility Contacts

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Jun Chen, Ph.D

Role: primary

References

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Crouser ED, Parrillo JE, Seymour CW, Angus DC, Bicking K, Esguerra VG, Peck-Palmer OM, Magari RT, Julian MW, Kleven JM, Raj PJ, Procopio G, Careaga D, Tejidor L. Monocyte Distribution Width: A Novel Indicator of Sepsis-2 and Sepsis-3 in High-Risk Emergency Department Patients. Crit Care Med. 2019 Aug;47(8):1018-1025. doi: 10.1097/CCM.0000000000003799.

Reference Type BACKGROUND
PMID: 31107278 (View on PubMed)

Crouser ED, Parrillo JE, Martin GS, Huang DT, Hausfater P, Grigorov I, Careaga D, Osborn T, Hasan M, Tejidor L. Monocyte distribution width enhances early sepsis detection in the emergency department beyond SIRS and qSOFA. J Intensive Care. 2020 May 5;8:33. doi: 10.1186/s40560-020-00446-3. eCollection 2020.

Reference Type BACKGROUND
PMID: 32391157 (View on PubMed)

Agnello L, Bivona G, Vidali M, Scazzone C, Giglio RV, Iacolino G, Iacona A, Mancuso S, Ciaccio AM, Lo Sasso B, Ciaccio M. Monocyte distribution width (MDW) as a screening tool for sepsis in the Emergency Department. Clin Chem Lab Med. 2020 Oct 25;58(11):1951-1957. doi: 10.1515/cclm-2020-0417.

Reference Type BACKGROUND
PMID: 32598299 (View on PubMed)

Moreira J, Paixao A, Oliveira J, Jalo W, Manuel O, Rodrigues R, Oliveira A, Tinoco L, Lima J, Grinsztejn B, Veloso VG, Japiassu AM, Lamas CC. Accuracy of quick sequential organ failure assessment score to predict mortality in hospitalized patients with suspected infection in an HIV/AIDS reference centre in Rio de Janeiro, Brazil. Clin Microbiol Infect. 2019 Jan;25(1):113.e1-113.e3. doi: 10.1016/j.cmi.2018.08.003. Epub 2018 Aug 15.

Reference Type BACKGROUND
PMID: 30118761 (View on PubMed)

Sun J, Shao Y, Jiang R, Qi T, Xun J, Shen Y, Zhang R, Qian L, Wang X, Liu L, Wang Z, Sun J, Tang Y, Song W, Xu S, Yang J, Chen Y, Tang YW, Lu H, Chen J. Monocyte distribution width (MDW) as a reliable diagnostic biomarker for sepsis in patients with HIV. Emerg Microbes Infect. 2025 Dec;14(1):2479634. doi: 10.1080/22221751.2025.2479634. Epub 2025 Mar 26.

Reference Type DERIVED
PMID: 40094401 (View on PubMed)

Other Identifiers

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HIV-MDW

Identifier Type: -

Identifier Source: org_study_id