Infection / Sublingual Microcirculation Assessment / Sepsis · Observational Study

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

ClinicalTrials.gov · September 1, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an observational cohort study that has not yet begun recruitment. The study aims to evaluate plasma neprilysin as a diagnostic biomarker for predicting sepsis development within 48 hours in ICU patients with confirmed or suspected infection. No results are available from this record.

What was studied

Observational. Sepsis, Infection; age from 18 Years. Intervention: ICU Participants With Infection or Suspected Infection. n = 488. 2 sites: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an ongoing observational registry study with no results reported; it is designed to explore whether plasma neprilysin predicts sepsis development within 48 hours in ICU patients.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Development of sepsis within 48 hours (assessed at From enrollment through 48 hours)

DesignObservational

PopulationSepsis, Infection; age from 18 Years

Sample size488

InterventionICU Participants With Infection or Suspected Infection

Setting2 sites: China

Reported figures

Quoted from the source exactly as published.

Planned sample size488

Primary outcome measureDevelopment of sepsis within 48 hours

Follow-up duration for survivalDay 28

Caveats

Study has not yet begun recruitment; no results are available in this registry record.
No comparator arm specified; observational design without control group.
Effect sizes, diagnostic accuracy, sensitivity, specificity, and any clinical outcomes are not reported in this record.
Sublingual microcirculation assessment is noted as 'when feasible,' indicating optional rather than systematic measurement.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Multicenter prospective observational cohort; no randomization or control group.

Directness

strong

Primary outcome is sepsis development within 48 hours; direct clinical endpoint.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Study not yet recruiting; conduct and bias risk unknown.

Sample adequacy

moderate

Planned enrollment 488 participants across two centers; adequate for observational design.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07796386). This is a study registration, not published results. Lead sponsor: Zhujiang Hospital. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 488 participants (ESTIMATED). Conditions: Sepsis, Infection. Interventions: DIAGNOSTIC_TEST: Plasma Neprilysin Measurement; DIAGNOSTIC_TEST: Conventional Sepsis Biomarker Measurement; DIAGNOSTIC_TEST: Sublingual Microcirculation Assessment. Primary outcome measures: Development of sepsis within 48 hours , From enrollment through 48 hours. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

InfectionZhujiang HospitalNCT07796386Sublingual Microcirculation AssessmentSepsisPlasma Neprilysin MeasurementConventional Sepsis Biomarker Measurement