Detection of Sepsis Occurrence by Using Blood Fluorescence

NCT06689189 | Recruiting DMC

• 1 other identifier: KY2023SL338-01
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Organ Damage

Keywords

Sepsis; Organ damage; Blood metabolite fluorescence; Machine learning; Deep learning; Fluorescence spectrum analytical platform

Outcome Measures

Primary Outcomes (1)

• specificity and sensitivity of blood fluorescence intensity in diagnosing sepsis.

  The primary outcome variable for this clinical trial is the specificity and sensitivity of blood fluorescence intensity in diagnosing sepsis.

  1 year

Secondary Outcomes (1)

• the correlation coefficients between the fluorescence intensity and other variables

  1 year

Study Arms (4)

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.

Other: Blood fluorescence metabolite analysis

Infected Non-Sepsis Patient Group

Patients with infections and a SOFA score of 1 will be screened and confirmed by a physician to meet the inclusion criteria. After obtaining informed consent, a nurse will collect a 4 cc blood sample within 24 hours of qualification. Within 7 days of ICU admission, physicians will assess whether patients with non-sepsis infections progress to sepsis. If so, these patients will be categorized into the sepsis patient group. One week post-discharge and on the 28th day post-diagnosis, a nurse will follow up to inquire about their health status.

Other: Blood fluorescence metabolite analysis

Vasopressorin treated sepsis group

Patients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, accepted with vasopressor therapy, will be screened and confirmed by a physician to meet the inclusion criteria. After physician confirmation that the inclusion criteria are met, patients will be informed and asked to sign an informed consent form. Blood samples (4 cc) will be collected within 24 hours before and after hospitalization entry and within 24h after transferred out of the ICU.

Other: Blood fluorescence metabolite analysis

No vasopressor theapy sepsis group

Group/Cohort Description: Patients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, without vasopressor therapy, will be screened and confirmed by a physician to meet the inclusion criteria. After physician confirmation that the inclusion criteria are met, patients will be informed and asked to sign an informed consent form. Blood samples (4 cc) will be collected within 24 hours before and after hospitalization entry.

Other: Blood fluorescence metabolite analysis

Interventions

Blood fluorescence metabolite analysis OTHER

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. Subsequently, the fluorescence intensity of the blood is measured quantitatively using a precisely calibrated blood fluorometer, which is specifically designed to detect subtle variations indicative of both early and late sepsis. This entire process is executed under stringent quality control protocols to ensure the reliability and accuracy of the results, which are pivotal for the timely diagnosis and intervention in septic patients.

Healthy control group; Infected Non-Sepsis Patient Group; No vasopressor theapy sepsis group; Vasopressorin treated sepsis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 Groups: Inpatients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, will be screened and confirmed by a physician to meet the inclusion criteria. The experimental group in this study was divided into two subgroups. One was the group of sepsis patients who used vasopressors, and the other was the group of sepsis patients who did not use vasopressors. 3. Non-septic Severe Control Group: Inpatients with suspected or confirmed infections, having a SOFA score of 1, will be screened and confirmed by a physician to meet the inclusion criteria.

You may qualify if:

• 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.

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead
• University of Macau: collaborator

Study Sites (1)

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

Ningbo, Zhejiang, 315010, China

RECRUITING

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fei Guo, Dr.

CONTACT

86 13646607121; lhlguofei@nbu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: January 24, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

CN (1)