BIomarkers to Predict the Outcomes of Sepsis

Study Overview
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Brief Summary
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Sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. However, sepsis remains the main threat to global health. Due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. The purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.

Detailed Description
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Sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. There are reports that the mortality rate of sepsis patients is 25-30%, and the hospital mortality rate of septic shock is as high as 40-60%. According to Lancet data, in 2017, there were 48.9 million cases of sepsis worldwide, resulting in approximately 11 million deaths, accounting for 19.7% of the total global deaths. Surviving sepsis patients often experience secondary infections and chronic organ dysfunction, which affects their long-term quality of life and poses a huge socio-economic burden. The World Health Organization (WHO) has identified sepsis as a global health priority and called for improving the level of sepsis prevention and treatment. With the advancement of medical technology, the diagnostic and treatment guidelines for sepsis are constantly updated, and clinical treatment capabilities have been improved. However, sepsis remains the main threat to global health. Due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. The purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.

Official Title
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BIomarkers to Predict the Outcomes of Sepsis

Conditions
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Sepsis

Intervention / Treatment
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* Other: sepsis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - The clinical diagnostic criteria for sepsis or septic shock that comply with the 3rd edition of the International Consensus on Sepsis and Sepsis Shock (Sepsis-3.0) are: Sepsis-3.0 sepsis diagnosis criteria: infection or suspected infection with a Sequential Organ Failure Score (SOFA score) ≥ 2 points; Sepsis-3.0 diagnostic criteria for septic shock: Sepsis with persistent hypotension, after sufficient fluid resuscitation, still requires vasopressor drugs to maintain average arterial pressure ≥ 65mmHg, and serum lactate level>2mmol/L (18mg/dL). Age 18 to 85 years old Exclusion Criteria: patients with autoimmune disease, acquired immunodeficiency syndrome, agranulocytosis (<0.5 × 109/L), malignant tumors or other serious chronic diseases (heart failure, Liver failure, end-stage renal disease, etc.); Receiving glucocorticoid treatment; Pregnancy; Refuse enrollment or give up active treatment. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| sepsis<br>sepsis patients | Other: sepsis<br>* collect 5ml blood from patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28d all-cause mortality | 28d all-cause mortality | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of secondary infection | recurrence, double infection and new infection | Day 0 to 28 | 
| ICU stays | ICU stays | 90 days | 
| Hospital stays | Hospital stays | 90 days | 
| re-hospitalization rate | re-hospitalization rate | 90 days | 
| SOFA score | SOFA score | at days -1, 7, 14 and 28 | 
| all-cause mortality | all-cause mortality | 90 days | 
| ICU mortality | ICU mortality | 90 days | 
| 28-day ventilator-free days | 28-day ventilator-free days | 28-day | 
| 28-day ICU-free days | 28-day ICU-free days | 28-day | 
| 28-day CRRT-free days | 28-day CRRT-free days | 28-day | 
| 28-day Vasoactive agents-free days | 28-day Vasoactive agents-free days | 28-day | 
| Septic shock | The incidence of septic shock | 28-day | 
| Sepsis heart injury | Ejection fraction<50% and left ventricular ejection fraction (LVEF) decreased by 10% from baseline，changes in biomarkers such as CKMB、cTNI caused by sepsis | 28-day | 
| Sepsis renal injury | Changes in biomarkers such as creatinine caused by sepsis | 28-day | 
| Sepsis liver injury | Changes in biomarkers such as ALT，AST caused by sepsis | 28-day | 
| Out-of-hospital mortality rate | Mortality rate within one year after discharge | Discharge for one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, biomarker