跳至主要内容
临床试验/NCT06689189
NCT06689189招募中不适用

Metabolite Fluorescence Analysis in Critically Ill Patients' Blood and the Development of a Blood Fluorescence Analytical Platform

Ningbo Medical Center Lihuili Hospital1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2024年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
800
试验地点
1
主要终点
specificity and sensitivity of blood fluorescence intensity in diagnosing sepsis.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • minors, pregnant, individuals with mental illnesses, and other vulnerable groups.

结局指标

主要结局

specificity and sensitivity of blood fluorescence intensity in diagnosing sepsis.

时间窗: 1 year

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

次要结局

  • the correlation coefficients between the fluorescence intensity and other variables(1 year)

研究者

发起方
Ningbo Medical Center Lihuili Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验