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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05229328
Other study ID # KY20212172
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 26, 2021
Est. completion date December 31, 2024

Study information

Verified date November 2022
Source Xijing Hospital
Contact Wen Yin
Phone 13809186660
Email xjyyyw@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
Peripheral blood test
Collect peripheral blood to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to find indicators related to disease deterioration and prognosis

Locations

Country Name City State
China The First Affillated Hospital,the Air Force Medical University Xi'an Shannxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Surviving or Died Participants with sepsis Prognosis Day 30
Primary Rate of Surviving or Died Participants with sepsis Prognosis Day 90
Secondary Sepsis-associated liver injury Concentration of Alanine aminotransferase(ALT) >80 U/L or Glutamine oxaloacetic transaminase (GOT,AST) >80 U/L, Concentration of total bilirubin(TBIL)>2mg/dl(34µmol/l) Day 0
Secondary Sepsis-associated kidney injury Concentration of Creatinine(Cr)>2 mg/dl or Urine output < 500ml/Day Day 0
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