Detection of Sepsis Occurrence by Using Blood Fluorescence

Ningbo Medical Center Lihuili Hospital

Status: Enrolling

Conditions: Organ Damage; Sepsis

Treatments: Other: Blood fluorescence metabolite analysis

Study type: Observational

Funder types: Other

Identifiers

NCT06689189

KY2023SL338-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

800 participants in 4 patient groups

Healthy control group

Description:

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.

Treatment:

Other: Blood fluorescence metabolite analysis

Infected Non-Sepsis Patient Group

Description:

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.

Treatment:

Other: Blood fluorescence metabolite analysis

Vasopressorin treated sepsis group

Description:

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.

Treatment:

Other: Blood fluorescence metabolite analysis

No vasopressor theapy sepsis group

Description:

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.

Treatment:

Other: Blood fluorescence metabolite analysis