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

Sponsor
Zhujiang Hospital
Study ID
NCT07796386
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Infection
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Plasma Neprilysin Measurement — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    Plasma will be batch-tested for interleukin-6, C-reactive protein, and procalcitonin for comparison with plasma neprilysin.
  • Sublingual Microcirculation Assessment — DIAGNOSTIC_TEST
    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 Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Aug 1, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
488 participants (estimated)

Arms

  • Arm: ICU Participants With Infection or Suspected Infection
    Adults admitted to the intensive care unit with confirmed or suspected infection who do not meet the protocol-defined criteria for sepsis at enrollment. Participants will be observed for the development of sepsis through 48 hours and followed for survival through Day 28.

Primary Outcome Measure

Development of sepsis within 48 hours [ Time Frame: From enrollment through 48 hours ]

Central Contacts

Related Studies