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NOT YET RECRUITING
NCT07796386

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

Sponsor: Zhujiang Hospital

View on ClinicalTrials.gov

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.

Official title: Plasma Neprilysin for Early Prediction of Sepsis Within 48 Hours in ICU Patients With Infection or Suspected Infection (NEPSIS): A Multicenter Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

488

Start Date

2026-08-01

Completion Date

2028-04-30

Last Updated

2026-09-01

Healthy Volunteers

No

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.

Locations (2)

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, China