Detection of Sepsis Occurrence by Using Blood Fluorescence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood fluorescence metabolite analysis.
- Who it may be relevant to
- Registry conditions: Sepsis, Organ Damage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Metabolite Fluorescence Analysis in Critically Ill Patients' Blood and the Development of a Blood Fluorescence Analytical Platform
Overview
This study adopted a case-control study method to explore a reagent-free, highly sensitive, and frequently screened blood fluorescence metabolite analyzer for sepsis, which can detect the emergence of inflammatory free radicals before organ damage and shorten the diagnosis time of sepsis.
Detailed description
Currently, clinical practice lacks an effective screening method for early detection and prediction of sepsis. This gap hinders timely differential diagnosis, leading to severe shock and increased mortality rates. Although the qSOFA score is highly specific, it is not devoid of false negatives. Typically, by the time sepsis is confirmed using the qSOFA (≥ 2) and SOFA (≥ 2) scores as gold standards, the patient may already be suffering from organ damage, thus escalating the risk of death. Early-stage septic patients exhibit a surge in inflammatory free radicals, altering the optical characteristics of their blood compared to that of healthy individuals. Based on this, we hypothesize that a blood fluorometer could detect these early changes in septic patients, enabling rapid and accurate diagnosis to mitigate mortality rates. This study will conduct a case-control investigation, collecting blood from both admitted and discharged patients, with the aim of developing a reagent-free, highly sensitive blood fluorescence metabolite analyzer. This device will be capable of frequent sepsis screenings, detecting inflammatory free radicals before organ damage occurs, thereby reducing the time to sepsis diagnosis.
Interventions
- Other Blood fluorescence metabolite analysis
This is an observational study and does not involve intervention. In both the early and late stages of sepsis, a significant increase in inflammatory free radicals changes the optical properties of the patient\'s blood, distinguishing it from that of healthy individuals. To explore this phenomenon, 4 cc of fasting blood is drawn from patients who pass our screening criteria. This sample is then centrifuged in accordance with our detailed standard operating procedures to ready it for analysis
Primary outcome measures
- specificity and sensitivity of blood fluorescence intensity in diagnosing sepsis. [Time frame: 1 year]
Secondary outcome measures (1)
- the correlation coefficients between the fluorescence intensity and other variables [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ningbo Institute of Innovation for Combined Medicine and Engineering (NIIME), Ningbo Medic — Ningbo
Publications
- Guo F, Zhu X, Wu Z, Zhu L, Wu J, Zhang F. Clinical applications of machine learning in the survival prediction and classification of sepsis: coagulation and heparin usage matter. J Transl Med. 2022 Jun 11;20(1):265. doi: 10.1186/s12967-022-03469-6. PMID 35690822
- Li Y, He Y, Miao K, Zheng Y, Deng C, Liu TM. Imaging of macrophage mitochondria dynamics in vivo reveals cellular activation phenotype for diagnosis. Theranostics. 2020 Feb 3;10(7):2897-2917. doi: 10.7150/thno.40495. eCollection 2020. PMID 32194843
- Shen YF, Tsai MR, Chen SC, Leung YS, Hsieh CT, Chen YS, Huang FL, Obena RP, Zulueta MM, Huang HY, Lee WJ, Tang KC, Kung CT, Chen MH, Shieh DB, Chen YJ, Liu TM, Chou PT, Sun CK. Imaging Endogenous Bilirubins with Two-Photon Fluorescence of Bilirubin Dimers. Anal Chem. 2015 Aug 4;87(15):7575-82. doi: 10.1021/acs.analchem.5b01903. Epub 2015 Jul 16. PMID 26146882
- Wu X, Guo LZ, Liu YH, Liu YC, Yang PL, Leung YS, Tai HC, Wang TD, Lin JC, Lai CL, Chuang YH, Lin CH, Chou PT, Lai IR, Liu TM. Plasma riboflavin fluorescence as a diagnostic marker of mesenteric ischemia-reperfusion injury in rats. Thromb Res. 2023 Mar;223:146-154. doi: 10.1016/j.thromres.2023.01.032. Epub 2023 Feb 3. PMID 36753876
Identifiers
NCT: NCT06689189 · KY2023SL338-01