Clinical trial NCT05842980: BIomarkers to Predict the Outcomes of Sepsis
Official title: BIomarkers to Predict the Outcomes of Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis
biomarker
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion of patients diagnosed with sepsis

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.

Eligibility criteria: Inclusion Criteria:

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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:

1. Sepsis-3.0 sepsis diagnosis criteria: infection or suspected infection with a Sequential Organ Failure Score (SOFA score) ≥ 2 points;
2. 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).
3. Age 18 to 85 years old

Exclusion Criteria:

1. 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.);
2. Receiving glucocorticoid treatment;
3. Pregnancy;
4. Refuse enrollment or give up active treatment. -

Primary outcomes:
measure: 28d all-cause mortality
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of secondary infection
timeFrame: Day 0 to 28
measure: ICU stays
timeFrame: 90 days
measure: Hospital stays
timeFrame: 90 days
measure: re-hospitalization rate
timeFrame: 90 days
measure: SOFA score
timeFrame: at days -1, 7, 14 and 28
measure: all-cause mortality
timeFrame: 90 days
measure: ICU mortality
timeFrame: 90 days
measure: 28-day ventilator-free days
timeFrame: 28-day
measure: 28-day ICU-free days
timeFrame: 28-day
measure: 28-day CRRT-free days
timeFrame: 28-day
measure: 28-day Vasoactive agents-free days
timeFrame: 28-day
measure: Septic shock
timeFrame: 28-day
measure: Sepsis heart injury
timeFrame: 28-day
measure: Sepsis renal injury
timeFrame: 28-day
measure: Sepsis liver injury
timeFrame: 28-day
measure: Out-of-hospital mortality rate
timeFrame: Discharge for one year
Other outcomes:
Locations:
city: Ji'nan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: