Plasma Neprilysin Measurement: Plasma collected at enrollment will be tested for neprilysin using an enzyme-linked immunosorbent assay. The result will not be used to guide clinical treatment.
Conventional Sepsis Biomarker Measurement: Plasma will be batch-tested for interleukin-6, C-reactive protein, and procalcitonin for comparison with plasma neprilysin.
Sublingual Microcirculation Assessment: Sublingual microcirculation will be assessed when oral conditions permit. Measurements will include microvascular flow index, perfused vessel density, and perfused boundary region. The results will not be used to assign treatment.
Study summary
The goal of this multicenter prospective observational cohort study is to determine whether plasma neprilysin can predict the development of sepsis within 48 hours in adults admitted to an intensive care unit with confirmed or suspected infection who do not have sepsis at enrollment.
The study will be conducted at Zhujiang Hospital, Southern Medical University, and Guangzhou First Municipal People's Hospital. Plasma samples remaining after routine clinical testing will be used to measure neprilysin and conventional sepsis biomarkers. Sublingual microcirculation will also be assessed when feasible.
Participants will be assessed for the development of sepsis from enrollment through 48 hours and will be followed for survival through Day 28. No treatment or clinical intervention will be assigned by the study protocol.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age 18 years or older.
* Confirmed or suspected infection as assessed by the treating physician based on symptoms, signs, laboratory findings, imaging findings, microbiological findings, or evidence of an infection source, with systemic antimicrobial therapy initiated or planned.
* Does not meet the protocol-defined criteria for sepsis at enrollment. In the setting of confirmed or suspected infection, there must be no acute increase of 2 or more points in the Sequential Organ Failure Assessment 2 score from baseline that is attributable to infection.
* Expected by the treating physician to remain in the intensive care unit for more than 48 hours after enrollment.
* Written informed consent provided by the participant or the participant's legally authorized representative.
Exclusion Criteria:
* Sepsis diagnosed at intensive care unit admission or fulfillment of the Sepsis-3 criteria at screening.
* Insufficient clinical data to determine the baseline SOFA-2 score according to the prespecified assessment criteria.
* Patients with limited nursing care (patients for whom active treatment has been withdrawn)
* No blood sample is available on the day of enrollment.
* Considered unsuitable for participation by the investigator.
Primary outcome measure(s)
Development of sepsis within 48 hours — From enrollment through 48 hours The reference outcome is the development of sepsis within 48 hours after enrollment. Sepsis is defined as confirmed or suspected infection with an acute increase of at least 2 points in the Sequential Organ Failure Assessment 2 score from baseline that is attributable to infection. The predictive performance of baseline plasma neprilysin will be summarized using the area under the receiver operating characteristic curve with its 95 percent confidence interval. Sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios will also be reported at the selected cutoff value.
Trial sites (2)
Facility
City
Region
Status
Guangzhou First People's Hospital
Guangzhou
Guangdong
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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