Clinical trial Recruiting at 1 site Observational Ages 18 and up

Detecting sepsis using blood fluorescence analysis

Official title: Metabolite Fluorescence Analysis in Critically Ill Patients' Blood and the Development of a Blood Fluorescence Analytical Platform

Run by Ningbo Medical Center Lihuili Hospital · NCT06689189 · Data updated 2026-11-12

This study is testing a new way to use blood samples to quickly spot sepsis in patients before it causes serious harm.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment800 (estimated)
SponsorNingbo Medical Center Lihuili Hospital
Government
Locations1 site (Ningbo, Zhejiang)
StatusRecruiting
StartedJanuary 24, 2024
Main results expectedOctober 1, 2026
Study endsOctober 1, 2027
Registry record updatedNovember 14, 2024
Trial IDNCT06689189 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults with confirmed infections exhibiting qSOFA scores of 2 or higher, as well as healthy individuals for comparison.

Probably not a fit

Patients who are minors, pregnant, or have mental illnesses, as well as those with other vulnerabilities, will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop a reagent-free blood fluorescence metabolite analyzer to detect sepsis at an early stage, before organ damage occurs. By utilizing a case-control method, the study will compare blood samples from healthy individuals, septic patients, and non-septic severe patients to identify changes in blood optical characteristics associated with inflammatory free radicals. The goal is to create a highly sensitive screening tool that can reduce the time to diagnosis and improve patient outcomes in sepsis management.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection of sepsis, potentially reducing mortality rates associated with the condition.

How similar studies have gone: While there have been studies exploring early detection of sepsis, this specific approach using blood fluorescence analysis is novel and has not been widely tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Healthy control group: Individuals who are physically healthy with no underlying diseases and have not been hospitalized within the past two years. Recruitment for healthy volunteers will be conducted through notices and online media.
2. Sepsis Experimental Group: Patients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, will be screened and confirmed by a physician to meet the inclusion criteria.
3. Non-septic Severe Control Group: Patients with suspected or confirmed infections, having a SOFA score of 1, will be screened and confirmed by a physician to meet the inclusion criteria.

Exclusion Criteria: minors, pregnant, individuals with mental illnesses, and other vulnerable groups.

Where it's running

  • Ningbo Institute of Innovation for Combined Medicine and Engineering (NIIME), Ningbo Medical Center Lihuili Hospital, Ningbo University
    Ningbo, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.