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NCT Number: NCT06689189

Detection of Sepsis Occurrence by Using Blood Fluorescence

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ningbo, Zhejiang, 315010, China

Location status: Recruiting

Location contact

Fei Guo, Dr.

PRINCIPAL_INVESTIGATOR

Ningbo Medical Center Lihuili Hospital

CONTACT

[email protected]

008687018701

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 1 year

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

Secondary outcomes

  1. the correlation coefficients between the fluorescence intensity and other variables

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Guo, Dr.

CONTACT

[email protected]

86 13646607121

Sponsors and collaborators

Lead sponsor

Ningbo Medical Center Lihuili Hospital

Other Gov

Collaborators

  • University of Macau

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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