Clinical trial NCT05229328: Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Sepsis
Official title: Study on the Establishment of a System for Early Warning and Prognostic Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Prognosis
Liver Injury
Kidney Injury
Early Waking
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Healthy Volunteers;
2. Adult patients who meet the criteria for sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
3. Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Surviving or Died Participants with sepsis
timeFrame: Day 30
measure: Rate of Surviving or Died Participants with sepsis
timeFrame: Day 90
Secondary outcomes:
measure: Sepsis-associated liver injury
timeFrame: Day 0
measure: Sepsis-associated kidney injury
timeFrame: Day 0
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affillated Hospital,the Air Force Medical University
state: Shannxi
Study officials:
affiliation: The First Affillated Hospital,the Air Force Medical University
name: Yanyan Jia
role: STUDY_CHAIR
References: