Clinical trial NCT05095324: The Biomarker Prediction Model of Septic Risk in Infected Patients
Official title: The Biomarker Prediction Model of Septic Risk in Infected Patients: Observational Multi-center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Early Diagnosis
Biomarkers
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: First Hospital of Tsinghua University
name: Renmin Hospital of Wuhan University
name: Hebei Medical University Third Hospital
name: Tianjin Medical University General Hospital
First posted: 2021-10-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who visit the emergency of the research center hospital

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.

Detailed description: According to the definition, infection is the original source of sepsis. How can diagnose organ failure early is the most impotent thing which can prevention the sepsis. In 2021, the guidelines for management of septic and septic shock recommend Sequential Organ Failure Assessment (SOFA) and systemic inflammatory response syndrome (SIRS) to diagnose sepsis. The standards of SOFA were acquired from clinical manifestations，such as blood pressure, oxygenation index, platelet, etc. These indexes can abnormal at the end of organ failure. On the other hand, it is difficult to acquire these indexes in emergency. There is wide variation in diagnostic accuracy of these tools with most having poor predictive values.

The number of publications related to sepsis biomarkers has increased over the years. The proportion of new biomarkers has decreased. Because of the complexity of the sepsis response, single biomarker might be fruitless. The investigators want to use the cytokines which have found and can represent the function of the organ in septic patients. The investigations can use these biomarkers of respiratory system, circulation, liver, renal system, coagulation and nervous system, to build up a prediction model of septic risk in infected patients.

The participants will be divided into "training set" and "verification set" randomly. The proportion of training set: verification set is 3:2. In the training set, the investigators will compare the cytokines between infection and sepsis. In sepsis patients, the investigators will compare the data between "organ failure group" and "control group", and use these data to build up the prediction model of septic risk. These data will be verify the validity and accuracy of the model in the verification set.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: the change of biomarkers between the septic patients with and without ARDS
timeFrame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
measure: the change of biomarkers between the septic patients with and without disturbance of consciousness
timeFrame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
measure: the change of biomarkers between the septic patients with and without abnormal coagulation function
timeFrame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
measure: the change of biomarkers between the septic patients with and without circulatory failure
timeFrame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
measure: the change of biomarkers between the septic patients with and without acute kidney failure
timeFrame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
measure: the change of biomarkers between the septic patients with and without liver failure
timeFrame: Participant will be followed up to 14 days to observe whether they can be diagnosed sepsis or not.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tsinghua Changgung Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Chang Gung Hospital
name: Wang zhong, master
role: STUDY_CHAIR
References: