Detection of Sepsis Occurrence by Using Blood Fluorescence

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Blood fluorescence metabolite analyzer
  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 crit

Первичные конечные точки

• specificity and sensitivity of blood fluorescence intensity in diagnosing sepsis. [Срок оценки: 1 year]

Вторичные конечные точки (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. [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• zhujiang Hospital — Гуанчжоу

Идентификаторы

NCT: NCT06745115 · 2022-KY133-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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