SepsisNCT05095324
The Biomarker Prediction Model of Septic Risk in Infected Patients
An observational study of Sepsis and Early Diagnosis, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to an infection. Sepsis is associated with high mortality because of the complex mechanisms. In China, the mortality of sepsis in ICU was up to 35.5%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Early Diagnosis, Biomarkers
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2021to 14 Sep 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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: patients who visit the emergency of the research center hospital
Who may be able to join
- Patients who meet any of the diagnostic criteria of "suspected infection", "confirmed infection" and "suspected sepsis".
Who cannot join
- age < 18 years old; pregnancy or breast-feeding; lack of informed consent by the patients or relatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Biomarker Prediction Model of Septic Risk in Infected Patients: Observational Multi-center Study
Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to an infection. Sepsis is associated with high mortality because of the complex mechanisms. In China, the mortality of sepsis in ICU was up to 35.5%. As a major and urgent global public health challenge，sepsis is hard to treat because of the complexion and highly heterogeneous in clinical manifestation. The early diagnosis and stratification of the infection is very important. If we can identify the patients who may developed into the sepsis, the therapeutic regimen was not only antibiotic, but also included stable the vascular endothelial cells，regulation of coagulation function and protection of organ functions. Biomarkers have an important place in sepsis because they are strictly related to the organ damage. Each organ has its own specific biomarkers, and these biomarkers will change according to the severity of the disease. So the investigators want to find the difference of biomarkers of each organ in patients from infection to spesis.
Read the detailed description
According to the definition, infection is the original source of sepsis. How can diagnose organ failure early is the most impotent thing which can prevention the sepsis. In 2021, the guidelines for management of septic and septic shock recommend Sequential Organ Failure Assessment (SOFA) and systemic inflammatory response syndrome (SIRS) to diagnose sepsis. The standards of SOFA were acquired from clinical manifestations，such as blood pressure, oxygenation index, platelet, etc. These indexes can abnormal at the end of organ failure. On the other hand, it is difficult to acquire these indexes in emergency. There is wide variation in diagnostic accuracy of these tools with most having poor predictive values.
The number of publications related to sepsis biomarkers has increased over the years. The proportion of new biomarkers has decreased. Because of the complexity of the sepsis response, single biomarker might be fruitless. The investigators want to use the cytokines which have found and can represent the function of the organ in septic patients. The investigations can use these biomarkers of respiratory system, circulation, liver, renal system, coagulation and nervous system, to build up a prediction model of septic risk in infected patients.
The participants will be divided into "training set" and "verification set" randomly. The proportion of training set: verification set is 3:2. In the training set, the investigators will compare the cytokines between infection and sepsis. In sepsis patients, the investigators will compare the data between "organ failure group" and "control group", and use these data to build up the prediction model of septic risk. These data will be verify the validity and accuracy of the model in the verification set.
- Conditions
- Sepsis, Early Diagnosis, Biomarkers
- Medical subject headings
- Sepsis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control | the infection patients who didn't have organ failure according to the SOFA score: 1. respiratory system: PaO2/FiO2≥<400 mmHg; 2. MAP≥70mmHg; 3. Liver: Bilirubin<1.2mg/dL; 4. Renal system: Creatinine<1.2mg/dL or Urine output≥500ml/d; 5. Platelets≥150×10^9/L; 6. nervous system:Glasgow coma score=15. | |
| organ failure | the patients who had sepsis in follow up period: 1. respiratory system:PaO2/FiO2<400mmHg; 2. Circulation: MAP<70mmHg or administration of vasopressors required; 3. Liver: Bilirubin≥1.2mg/dL; 4. Renal system: Creatinine≥1.2mg/dL or Urine output<500ml/d; 5. Coagulation: Platelets<150×10^9/L; 6. nervous system: Glasgow coma score <15. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of biomarkers between the septic patients with and without ARDS
endocan (the cutoff value is 2.45 ng/ml to diagnose ARDS); sydecan-1 and Ang 2 are also the biomarkers of ARDS, they can but the cutoff values are not certain.
Measured: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
the change of biomarkers between the septic patients with and without disturbance of consciousness
neuron-specific enolase (NSE), the cutoff value is 24.15 ng/ml to diagnose Septic encephalopathy; S100β: is a calcium-binding protein released by brain astrocytes. The increase of S100β is represents breakdown of the blood-brain barrier.
Measured: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
the change of biomarkers between the septic patients with and without abnormal coagulation function
tissue factor (TF): as the important components of exogenous coagulation pathways, TF will be elevated in sepsis. the cutoff value is 1005.8 pg/ml.
Measured: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
the change of biomarkers between the septic patients with and without circulatory failure
heart type fatty acid-binding protein (hFABP): The expression was increased in patients with septic myocardial injury, with intercept value ≥4.5 ng/mL, sensitivity of 83%, specificity of 73%. The myocardial enzyme will also be tested.
Measured: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
the change of biomarkers between the septic patients with and without acute kidney failure
neutrophil gelatinase-associated apolipoprotein (NGAL) and serial serum cell adhesion molecules (the cutoff value is 124.4 ng/ml)
Measured: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
the change of biomarkers between the septic patients with and without liver failure
Golgi body 73 (GP73): is rarely or not expressed in normal liver cells, but is relatively stable in bile duct epithelial cells of the liver. When liver lesions occur, the expression level of GP73 is significantly higher. endothelin-1 is another biomarker to evaluate the liver function in sepsis
Measured: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start7 Sep 2021
- Primary completion7 Sep 2022 (estimated)
- Study completion14 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, First Hospital of Tsinghua University, Renmin Hospital of Wuhan University, Hebei Medical University Third Hospital, Tianjin Medical University General Hospital
- Responsible party
- Sponsor
- Investigators
- Wang zhong, master, Study chair, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095324
- Sponsor's protocol ID
- 20210520
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Z, Wang X, Guo Z, Liao H, Chai Y, Wang Z, Wang Z. In silico high-throughput screening system for AKT1 activators with therapeutic applications in sepsis acute lung injury. Front Cell Infect Microbiol. 2022 Dec 12;12:1050497. doi: 10.3389/fcimb.2022.1050497. eCollection 2022.
PubMed 36579349
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biomarker Prediction Model of Septic Risk in Infected Patients: Observational Multi-center Study
- ClinicalTrials.gov ID
- NCT05095324
- Acronym / sponsor ID
- 20210520
- Conditions
- Sepsis, Early Diagnosis, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, First Hospital of Tsinghua University, Renmin Hospital of Wuhan University, Hebei Medical University Third Hospital, Tianjin Medical University General Hospital
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 7 Sep 2022 (estimated)
- Study completion
- 14 Sep 2022 (estimated)
- First posted
- 27 Oct 2021 (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.
Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to an infection. Sepsis is associated with high mortality because of the complex mechanisms. In China, the mortality of sepsis in ICU was up to 35.5%. As a major and urgent global public health challenge，sepsis is hard to treat because of the complexion and highly heterogeneous in clinical manifestation. The early diagnosis and stratification of the infection is very important. If we can identify the patients who may developed into the sepsis, the therapeutic regimen was not only antibiotic, but also included stable the vascular endothelial cells，regulation of coagulation function and protection of organ functions. Biomarkers have an important place in sepsis because they are strictly related to the organ damage. Each organ has its own specific biomarkers, and these biomarkers will change according to the severity of the disease. So the investigators want to find the difference of biomarkers of each organ in patients from infection to spesis.
Detailed description
According to the definition, infection is the original source of sepsis. How can diagnose organ failure early is the most impotent thing which can prevention the sepsis. In 2021, the guidelines for management of septic and septic shock recommend Sequential Organ Failure Assessment (SOFA) and systemic inflammatory response syndrome (SIRS) to diagnose sepsis. The standards of SOFA were acquired from clinical manifestations，such as blood pressure, oxygenation index, platelet, etc. These indexes can abnormal at the end of organ failure. On the other hand, it is difficult to acquire these indexes in emergency. There is wide variation in diagnostic accuracy of these tools with most having poor predictive values.
The number of publications related to sepsis biomarkers has increased over the years. The proportion of new biomarkers has decreased. Because of the complexity of the sepsis response, single biomarker might be fruitless. The investigators want to use the cytokines which have found and can represent the function of the organ in septic patients. The investigations can use these biomarkers of respiratory system, circulation, liver, renal system, coagulation and nervous system, to build up a prediction model of septic risk in infected patients.
The participants will be divided into "training set" and "verification set" randomly. The proportion of training set: verification set is 3:2. In the training set, the investigators will compare the cytokines between infection and sepsis. In sepsis patients, the investigators will compare the data between "organ failure group" and "control group", and use these data to build up the prediction model of septic risk. These data will be verify the validity and accuracy of the model in the verification set.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –the infection patients who didn't have organ failure according to the SOFA score: 1. respiratory system: PaO2/FiO2≥<400 mmHg; 2. MAP≥70mmHg; 3. Liver: Bilirubin<1.2mg/dL; 4. Renal system: Creatinine<1.2mg/dL or Urine output≥500ml/d; 5. Platelets≥150×10^9/L; 6. nervous system:Glasgow coma score=15. |
| organ failure | – | –the patients who had sepsis in follow up period: 1. respiratory system:PaO2/FiO2<400mmHg; 2. Circulation: MAP<70mmHg or administration of vasopressors required; 3. Liver: Bilirubin≥1.2mg/dL; 4. Renal system: Creatinine≥1.2mg/dL or Urine output<500ml/d; 5. Coagulation: Platelets<150×10^9/L; 6. nervous system: Glasgow coma score <15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who visit the emergency of the research center hospital
Key inclusion criteria (1 listed)
- Patients who meet any of the diagnostic criteria of "suspected infection", "confirmed infection" and "suspected sepsis".
Key exclusion criteria (1 listed)
- age < 18 years old; pregnancy or breast-feeding; lack of informed consent by the patients or relatives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the change of biomarkers between the septic patients with and without ARDS
Time frame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
endocan (the cutoff value is 2.45 ng/ml to diagnose ARDS); sydecan-1 and Ang 2 are also the biomarkers of ARDS, they can but the cutoff values are not certain.
the change of biomarkers between the septic patients with and without disturbance of consciousness
Time frame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
neuron-specific enolase (NSE), the cutoff value is 24.15 ng/ml to diagnose Septic encephalopathy; S100β: is a calcium-binding protein released by brain astrocytes. The increase of S100β is represents breakdown of the blood-brain barrier.
the change of biomarkers between the septic patients with and without abnormal coagulation function
Time frame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
tissue factor (TF): as the important components of exogenous coagulation pathways, TF will be elevated in sepsis. the cutoff value is 1005.8 pg/ml.
the change of biomarkers between the septic patients with and without circulatory failure
Time frame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
heart type fatty acid-binding protein (hFABP): The expression was increased in patients with septic myocardial injury, with intercept value ≥4.5 ng/mL, sensitivity of 83%, specificity of 73%. The myocardial enzyme will also be tested.
the change of biomarkers between the septic patients with and without acute kidney failure
Time frame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
neutrophil gelatinase-associated apolipoprotein (NGAL) and serial serum cell adhesion molecules (the cutoff value is 124.4 ng/ml)
the change of biomarkers between the septic patients with and without liver failure
Time frame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
Golgi body 73 (GP73): is rarely or not expressed in normal liver cells, but is relatively stable in bile duct epithelial cells of the liver. When liver lesions occur, the expression level of GP73 is significantly higher. endothelin-1 is another biomarker to evaluate the liver function in sepsis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 36579349Wang Z, Wang X, Guo Z, Liao H, Chai Y, Wang Z, Wang Z. In silico high-throughput screening system for AKT1 activators with therapeutic applications in sepsis acute lung injury. Front Cell Infect Microbiol. 2022 Dec 12;12:1050497. doi: 10.3389/fcimb.2022.1050497. eCollection 2022.
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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. This study is not recruiting at the moment.
Wang zhong, master study chair
Beijing Tsinghua Chang Gung Hospital
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 Early Diagnosis, run by Beijing Tsinghua Chang Gung 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of biomarkers between the septic patients with and without ARDS (time frame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.). The study lists 6 primary outcomes in all. 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 NCT05095324, which also lists 1 linked publication.
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 27 Oct 2021.