SepsisNCT06689189
Detection of Sepsis Occurrence by Using Blood Fluorescence
An observational study of Sepsis and Organ Damage, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Organ Damage
- What is being tested?
- Blood fluorescence metabolite analysis
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2024to 1 Oct 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 Groups: Inpatients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, will be screened and confirmed by a physician to meet the inclusion criteria. The experimental group in this study was divided into two subgroups. One was the group of sepsis patients who used vasopressors, and the other was the group of sepsis patients who did not use vasopressors. 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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ningbo Institute of Innovation for Combined Medicine and Engineering (NIIME), Ningbo Medical Center Lihuili Hospital, Ningbo University
Ningbo, Zhejiang, 315010
Ningbo Medical Center Lihuili Hospital, 008687018701, lhl2290@mail.nbptt.zj.cn
Fei Guo, Dr.
About this study
Official title: Metabolite Fluorescence Analysis in Critically Ill Patients' Blood and the Development of a Blood Fluorescence Analytical Platform
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.
Read the detailed 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.
- Conditions
- Sepsis, Organ Damage
- Being tested
- Blood fluorescence metabolite analysis
- Keywords
- Sepsis, Organ damage, Blood metabolite fluorescence, Machine learning, Deep learning, Fluorescence spectrum analytical platform
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood fluorescence metabolite analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood fluorescence metabolite analysis | |
| 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 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. Receives: Other: Blood fluorescence metabolite analysis | |
| Vasopressorin treated sepsis group | 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. Receives: Other: Blood fluorescence metabolite analysis | |
| No vasopressor theapy sepsis group | 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. Receives: Other: Blood fluorescence metabolite analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
the correlation coefficients between the fluorescence intensity and other variables
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start24 Jan 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Collaborators
- University of Macau
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689189
- Sponsor's protocol ID
- KY2023SL338-01
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo F, Zhu X, Wu Z, Zhu L, Wu J, Zhang F. Clinical applications of machine learning in the survival prediction and classification of sepsis: coagulation and heparin usage matter. J Transl Med. 2022 Jun 11;20(1):265. doi: 10.1186/s12967-022-03469-6.
PubMed 35690822Li Y, He Y, Miao K, Zheng Y, Deng C, Liu TM. Imaging of macrophage mitochondria dynamics in vivo reveals cellular activation phenotype for diagnosis. Theranostics. 2020 Feb 3;10(7):2897-2917. doi: 10.7150/thno.40495. eCollection 2020.
PubMed 32194843Shen YF, Tsai MR, Chen SC, Leung YS, Hsieh CT, Chen YS, Huang FL, Obena RP, Zulueta MM, Huang HY, Lee WJ, Tang KC, Kung CT, Chen MH, Shieh DB, Chen YJ, Liu TM, Chou PT, Sun CK. Imaging Endogenous Bilirubins with Two-Photon Fluorescence of Bilirubin Dimers. Anal Chem. 2015 Aug 4;87(15):7575-82. doi: 10.1021/acs.analchem.5b01903. Epub 2015 Jul 16.
PubMed 26146882Wu X, Guo LZ, Liu YH, Liu YC, Yang PL, Leung YS, Tai HC, Wang TD, Lin JC, Lai CL, Chuang YH, Lin CH, Chou PT, Lai IR, Liu TM. Plasma riboflavin fluorescence as a diagnostic marker of mesenteric ischemia-reperfusion injury in rats. Thromb Res. 2023 Mar;223:146-154. doi: 10.1016/j.thromres.2023.01.032. Epub 2023 Feb 3.
PubMed 36753876
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolite Fluorescence Analysis in Critically Ill Patients' Blood and the Development of a Blood Fluorescence Analytical Platform
- ClinicalTrials.gov ID
- NCT06689189
- Acronym / sponsor ID
- KY2023SL338-01
- Conditions
- Sepsis, Organ Damage
- Keywords
- Sepsis, Organ damage, Blood metabolite fluorescence, Machine learning, Deep learning, Fluorescence spectrum analytical platform
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Collaborators
- University of Macau
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | – | Other: Blood fluorescence metabolite analysisIndividuals 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. |
| Infected Non-Sepsis Patient Group | – | Other: Blood fluorescence metabolite analysisPatients 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. |
| Vasopressorin treated sepsis group | – | Other: Blood fluorescence metabolite analysisPatients 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. |
| No vasopressor theapy sepsis group | – | Other: Blood fluorescence metabolite analysisGroup/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 Groups: Inpatients with confirmed infections, having qSOFA ≥ 2 and SOFA ≥ 2, will be screened and confirmed by a physician to meet the inclusion criteria. The experimental group in this study was divided into two subgroups. One was the group of sepsis patients who used vasopressors, and the other was the group of sepsis patients who did not use vasopressors. 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood fluorescence metabolite analysisThis 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. | Other | Healthy control group, Infected Non-Sepsis Patient Group, No vasopressor theapy sepsis group, Vasopressorin treated sepsis group |
Primary outcome
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.
1 secondary outcome
the correlation coefficients between the fluorescence intensity and other variables
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Results publication: PubMed 35690822Guo F, Zhu X, Wu Z, Zhu L, Wu J, Zhang F. Clinical applications of machine learning in the survival prediction and classification of sepsis: coagulation and heparin usage matter. J Transl Med. 2022 Jun 11;20(1):265. doi: 10.1186/s12967-022-03469-6.
- Results publication: PubMed 32194843Li Y, He Y, Miao K, Zheng Y, Deng C, Liu TM. Imaging of macrophage mitochondria dynamics in vivo reveals cellular activation phenotype for diagnosis. Theranostics. 2020 Feb 3;10(7):2897-2917. doi: 10.7150/thno.40495. eCollection 2020.
- Results publication: PubMed 26146882Shen YF, Tsai MR, Chen SC, Leung YS, Hsieh CT, Chen YS, Huang FL, Obena RP, Zulueta MM, Huang HY, Lee WJ, Tang KC, Kung CT, Chen MH, Shieh DB, Chen YJ, Liu TM, Chou PT, Sun CK. Imaging Endogenous Bilirubins with Two-Photon Fluorescence of Bilirubin Dimers. Anal Chem. 2015 Aug 4;87(15):7575-82. doi: 10.1021/acs.analchem.5b01903. Epub 2015 Jul 16.
- Results publication: PubMed 36753876Wu X, Guo LZ, Liu YH, Liu YC, Yang PL, Leung YS, Tai HC, Wang TD, Lin JC, Lai CL, Chuang YH, Lin CH, Chou PT, Lai IR, Liu TM. Plasma riboflavin fluorescence as a diagnostic marker of mesenteric ischemia-reperfusion injury in rats. Thromb Res. 2023 Mar;223:146-154. doi: 10.1016/j.thromres.2023.01.032. Epub 2023 Feb 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Organ Damage, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Guo, Dr. (86 13646607121, lhlguofei@nbu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specificity and sensitivity of blood fluorescence intensity in diagnosing sepsis. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06689189, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.