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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05036928
• Other study ID #: HIV-MDW
• Status: Recruiting
• Start date: December 2021
• Est. completion date: October 2022

Study information

• Verified date: November 2021
• Source: Shanghai Public Health Clinical Center
• Contact: Jun Chen, Ph.D
• Phone: 021-37990333-3222
• Email: qtchenjun[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: October 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• Monocyte distribution width (MDW)
All enrolled patients will receive test with MDW.

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Moreira J, Paixão A, Oliveira J, Jaló W, Manuel O, Rodrigues R, Oliveira A, Tinoco L, Lima J, Grinsztejn B, Veloso VG, Japiassú 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of deaths of enrolled patients	In HIV infection with sepsis, whether higher MDW score is related to poor prognosis.	within 28 days