BIomarkers to Predict the Outcomes of Sepsis
- Conditions
- Sepsis
- Interventions
- Other: sepsis
- Registration Number
- NCT05842980
- Lead Sponsor
- Qilu Hospital of Shandong University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
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
- 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. -
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description sepsis sepsis sepsis patients
- Primary Outcome Measures
Name Time Method 28d all-cause mortality 28 days 28d all-cause mortality
- Secondary Outcome Measures
Name Time Method Hospital stays 90 days Hospital stays
SOFA score at days -1, 7, 14 and 28 SOFA score
28-day ventilator-free days 28-day 28-day ventilator-free days
28-day CRRT-free days 28-day 28-day CRRT-free days
Septic shock 28-day The incidence of septic shock
all-cause mortality 90 days all-cause mortality
ICU stays 90 days ICU stays
28-day ICU-free days 28-day 28-day ICU-free days
Sepsis liver injury 28-day Changes in biomarkers such as ALT，AST caused by sepsis
Incidence of secondary infection Day 0 to 28 recurrence, double infection and new infection
Sepsis renal injury 28-day Changes in biomarkers such as creatinine caused by sepsis
Out-of-hospital mortality rate Discharge for one year Mortality rate within one year after discharge
ICU mortality 90 days ICU mortality
28-day Vasoactive agents-free days 28-day 28-day Vasoactive agents-free days
re-hospitalization rate 90 days re-hospitalization rate
Sepsis heart injury 28-day Ejection fraction\<50% and left ventricular ejection fraction (LVEF) decreased by 10% from baseline，changes in biomarkers such as CKMB、cTNI caused by sepsis
Trial Locations
- Locations (1)
Qilu Hospital of Shandong University
🇨🇳Ji'nan, Shandong, China