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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections; Sepsis
• Intervention / Treatment: Diagnostic test: Monocyte distribution width (MDW）

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 Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Jun Chen, Ph.D; Phone Number: 021-37990333-3222; Email: qtchenjun@163.com
• Study Contact Backup: Name: Tangkai Qi, Ph.D; Phone Number: 021-37990333-3222; Email: qitangkai@shphc.org.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201508
      • Recruiting
      • Shanghai Public Health Clinical Center
      • Contact: Jun Chen, Ph.D; Email: qtchenjun@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

HIV-infected patients hospitalized in our hospital within 1 year since this study was conducted.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV infection group	Diagnostic test: Monocyte distribution width (MDW）; All enrolled patients will receive test with MDW.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Public Health Clinical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: HIV-MDW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No