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Plasma Neprilysin for Predicting Sepsis Within 48 Hours in ICU Patients With Infection or Suspected Infection

NCT07796386 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 488

Last updated 2026-09-01

No results posted yet for this 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.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Conventional Sepsis Biomarker Measurement

Plasma will be batch-tested for interleukin-6, C-reactive protein, and procalcitonin for comparison with plasma neprilysin.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Guangzhou First People's Hospital

    collaborator OTHER

  • Guangdong Basic and Applied Basic Science Foundation

    collaborator UNKNOWN

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Zhanguo Liu · Department of Critical Care Medicine of Zhujiang Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-12-31
Completion
2028-04-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07796386 on ClinicalTrials.gov