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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Liver Injury; Early Waking; Kidney Injury; Prognosis; Sepsis

Treatments: Diagnostic Test: Peripheral blood test

Study type: Observational

Funder types: Other

Identifiers

NCT05229328

KY20212172

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The patient who voluntarily signs an informed consent form;
2. Adult patients who meet the criteria for sepsis, who is registration to the hospital within 24 hours of onset;
3. 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;
4. 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

1. Age <18 years old or >90 years old;
2. Patients with advanced tumors, Pregnancy or lactation;
3. Patients who missed out during treatment and whose data are incomplete.

Trial design

300 participants in 3 patient groups

Control group

Description:

Healthy volunteers

Treatment:

Diagnostic Test: Peripheral blood test

Patients within the acute phase of disease

Description:

Patients within 24 hours after onset

Treatment:

Diagnostic Test: Peripheral blood test

Recovery phase of disease

Description:

Inflammation was controlled, shock was corrected, and the patient remained fever free for 3 consecutive days.

Treatment:

Diagnostic Test: Peripheral blood test