Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Sepsis

Study Overview
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Brief Summary
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Sepsis is a clinical syndrome with high morbidity and high fatality rate in emergency department. Patients with acute liver or kidney injury are more likely to develop Multiple Organ Dysfunction Syndrome(MODS) secondary to the non-hepatic injury group, and the prognosis deteriorates significantly. At present, there is no unified diagnostic criteria for acute liver injury associated with sepsis, and the commonly used prognostic evaluation system is rarely included in liver injury indicators, which is not good for practicality.

Detailed Description
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The project intends to collect the peripheral blood of the normal population, 24 hours after the onset of sepsis and patients in the recovery period. We will separate and extract plasma, Peripheral Blood Mononuclear Cell(PBMC), and plasma exosomal miRNA, and sequence to find indicators related to disease deterioration and prognosis. And then, we will construct and verify the early warning and prognosis evaluation system. On this basis, the researcher explore cellular and molecular mediated pathological mechanisms of sepsis, and then clarify the treatment target of sepsis.

Official Title
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Study on the Establishment of a System for Early Warning and Prognostic Evaluation

Conditions
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Sepsis, Prognosis, Liver Injury, Kidney Injury, Early Waking

Intervention / Treatment
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* Diagnostic Test: Peripheral blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient who voluntarily signs an informed consent form; Adult patients who meet the criteria for sepsis, who is registration to the hospital within 24 hours of onset; SEPSIS is defined as the sequential organ failure assessment (SOFA) score ≥ 2 within 24 hours after admission, accompanied by at least one site of infection; Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure(MAP) 65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation. Exclusion Criteria: Age <18 years old or >90 years old; Patients with advanced tumors, Pregnancy or lactation; Patients who missed out during treatment and whose data are incomplete.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Healthy volunteers | Diagnostic Test: Peripheral blood test<br>* Collect peripheral blood to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to find indicators related to disease deterioration and prognosis<br>|
| Patients within the acute phase of disease<br>Patients within 24 hours after onset | Diagnostic Test: Peripheral blood test<br>* Collect peripheral blood to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to find indicators related to disease deterioration and prognosis<br>|
| Recovery phase of disease<br>Inflammation was controlled, shock was corrected, and the patient remained fever free for 3 consecutive days. | Diagnostic Test: Peripheral blood test<br>* Collect peripheral blood to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to find indicators related to disease deterioration and prognosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Surviving or Died Participants with sepsis | Prognosis | Day 30 | 
| Rate of Surviving or Died Participants with sepsis | Prognosis | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis-associated liver injury | Concentration of Alanine aminotransferase(ALT) >80 U/L or Glutamine oxaloacetic transaminase (GOT,AST) >80 U/L, Concentration of total bilirubin(TBIL)>2mg/dl（34μmol/l） | Day 0 | 
| Sepsis-associated kidney injury | Concentration of Creatinine(Cr)>2 mg/dl or Urine output < 500ml/Day | Day 0 |