Detection of Sepsis Occurrence by Using Blood Fluorescence

NCT06745115 | Recruiting DMC

• 1 other identifier: 2022-KY133-01
• Study Type: observational
• Target: 90
• 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

Keywords

blood fluorescence; Sepsis; early detection

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 secondary outcome variables consist of correlation coefficients. These coefficients show the relationship between the fluorescence intensity of participants' blood and several other factors, including the length of their hospital stay.

  1 year

Study Arms (3)

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.

Diagnostic Test: Blood fluorescence metabolite analyzer

Sepsis Patient Group

Patients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, 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 (10 cc) will be collected within 24 hours before and after hospitalization entry. One week post-discharge and on the 28th day post-diagnosis, a nurse will follow up to inquire about their health status.

Diagnostic Test: Blood fluorescence metabolite analyzer

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 10 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.

Diagnostic Test: Blood fluorescence metabolite analyzer

Interventions

Blood fluorescence metabolite analyzer DIAGNOSTIC_TEST

This study does not involve Intervention. The fluorescence intensity quantified by the blood fluorescence metabolite analyzer does not affect or interfere with clinical diagnosis and treatment. 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, 10 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.

Healthy control group; Infected Non-Sepsis Patient Group; Sepsis Patient 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 Group: Inpatients 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: 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

• Zhujiang Hospital: lead
• University of Macau: collaborator

Study Sites (1)

zhujiang Hospital

Guangzhou, Guangdong, 510280, China

RECRUITING

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

Ning Zeng, Doctor

CONTACT

13760694012; chen_ning16@foxmail.com

Study Design

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

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: September 9, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 20, 2024

Record last verified: 2024-08

Locations

CN (1)