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Clinical Trials/NCT05229328
NCT05229328
Recruiting
Not Applicable

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

Xijing Hospital1 site in 1 country300 target enrollmentOctober 26, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Xijing Hospital
Enrollment
300
Locations
1
Primary Endpoint
Rate of Surviving or Died Participants with sepsis
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 26, 2021
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

Rate of Surviving or Died Participants with sepsis

Time Frame: Day 90

Prognosis

Secondary Outcomes

  • Sepsis-associated liver injury(Day 0)
  • Sepsis-associated kidney injury(Day 0)

Study Sites (1)

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