Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05229328
Enrollment
300
Registered
2022-02-08
Start date
2021-10-26
Completion date
2024-12-31
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Waking, Kidney Injury, Liver Injury, Prognosis, Sepsis

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.

Interventions

DIAGNOSTIC_TESTPeripheral 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

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of Surviving or Died Participants with sepsisDay 30Prognosis

Secondary

MeasureTime frameDescription
Sepsis-associated liver injuryDay 0Concentration 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)
Sepsis-associated kidney injuryDay 0Concentration of Creatinine(Cr)\>2 mg/dl or Urine output \< 500ml/Day

Countries

China

Contacts

Primary ContactWen Yin
xjyyyw@126.com13809186660
Backup ContactShanshou Liu
shanshouliu@126.com15091332280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026