Clinical trial NCT05036928: Study of MDW Levels Predicting the Development of Sepsis in Hospitalized HIV-infected Patients and Correlation With Prognosis
Official title: Study of MDW Levels Predicting the Development of Sepsis in Hospitalized HIV-infected Patients and Correlation With Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Sepsis
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2021-09-08
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected patients hospitalized in our hospital within 1 year since this study was conducted.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with sepsis of admission
timeFrame: within 28 days
measure: Number of deaths of enrolled patients
timeFrame: within 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References:
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.
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.
citation: 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.
citation: 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.