Detecting sepsis using blood fluorescence analysis
Metabolite Fluorescence Analysis in Critically Ill Patients' Blood and the Development of a Blood Fluorescence Analytical Platform
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 type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ningbo Medical Center Lihuili Hospital Government |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT06689189 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed infections exhibiting qSOFA scores of 2 or higher, as well as healthy individuals for comparison.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ningbo, Zhejiang
- Ningbo Institute of Innovation for Combined Medicine and Engineering (NIIME), Ningbo Medical Center Lihuili Hospital, Ningbo University — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Fei Guo, Dr.
- Email: lhlguofei@nbu.edu.cn
- Phone: 86 13646607121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.