The Biomarker Prediction Model of Septic Risk in Infected Patients

NCT05095324 | Unknown

• 1 other identifier: 20210520
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

Sepsis; Early Diagnosis; Biomarkers

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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)

  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

  Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who visit the emergency of the research center hospital

You may qualify if:

• Patients who meet any of the diagnostic criteria of "suspected infection", "confirmed infection" and "suspected sepsis".

You may not qualify if:

• age \< 18 years old; pregnancy or breast-feeding; lack of informed consent by the patients or relatives.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• Peking Union Medical College Hospital: collaborator
• First Hospital of Tsinghua University: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Hebei Medical University Third Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator

Study Sites (1)

Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Related Publications (1)

• 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.

  PMID: 36579349 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

we set a control staff and a liaison in each research center, they collect samples and store them at -80℃. we cold chain transport them to the testing center. All of the biomarker will be tested in designated laboratory.

MeSH Terms

Conditions

Sepsis; Disease

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wang zhong, master

  Beijing Tsinghua Chang Gung Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 27, 2021
• Study Start: September 7, 2021
• Primary Completion: September 7, 2022
• Study Completion: September 14, 2022
• Last Updated: October 27, 2021

Record last verified: 2021-09

Locations

CN (1)