Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06745115

Detection of Sepsis Occurrence Using Blood Fluorescence A Study to Explore a Sensitive, Reagent-Free Blood Test for Early Sepsis Detection

Led by Zhujiang Hospital · Updated on 2024-12-20

90

Participants Needed

1

Research Sites

211 weeks

Total Duration

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Sponsors

Z

Zhujiang Hospital

Lead Sponsor

U

University of Macau

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating a new blood fluorescence metabolite analyzer to improve early detection of sepsis. Sepsis is hard to diagnose early because current methods like qSOFA and SOFA scores often confirm the disease only after organ damage has occurred, increasing the risk of death. This study aims to develop a reagent-free, highly sensitive tool that can screen frequently for inflammatory free radicals in the blood, which appear early in sepsis before organ damage. The study collects blood samples from admitted and discharged patients, including healthy controls and those with varying severities of infection. A 10 cc fasting blood sample is drawn, processed by centrifugation, and then analyzed using a specialized blood fluorometer to measure fluorescence intensity changes linked to sepsis. This diagnostic test does not interfere with clinical diagnosis or treatment and is performed under strict quality control to ensure accurate and reliable results. Participants include healthy individuals with no recent hospitalizations and patients with confirmed or suspected infections categorized by qSOFA and SOFA scores. The study assesses the specificity and sensitivity of blood fluorescence intensity for diagnosing sepsis over one year. Researchers collect clinical data, perform blood fluorescence measurements, and monitor participants to evaluate the test's ability to detect sepsis early, aiming to reduce diagnosis time and improve patient outcomes.

CONDITIONS

Official Title

Detection of Sepsis Occurrence by Using Blood Fluorescence

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy individuals with no underlying diseases and no hospitalizations within the past two years
  • Patients with confirmed infection and qSOFA score 2 or higher and SOFA score 2 or higher
  • Patients with suspected or confirmed infections and SOFA score of 1
Not Eligible

You will not qualify if you...

  • Minors
  • Pregnant individuals
  • Individuals with mental illnesses
  • Other vulnerable groups

AI-Screening

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Trial Site Locations

Total: 1 location

1

zhujiang Hospital

Guangzhou, Guangdong, China, 510280

Actively Recruiting

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Research Team

N

Ning Zeng, Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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