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

Recruiting

• Conditions: Sepsis; Prognosis; Liver Injury; Early Waking; Kidney Injury
• Interventions: Diagnostic Test: Peripheral blood test

• Registration Number: NCT05229328
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Study Start: 2021-10-26
• Study First Submitted: 2021-11-14
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-08
• Status Verified: 2022-11
• Last Update Submitted: 2023-01-28
• Last Update Posted: 2023-01-31
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recovery phase of disease	Peripheral blood test	Inflammation was controlled, shock was corrected, and the patient remained fever free for 3 consecutive days.
Control group	Peripheral blood test	Healthy volunteers
Patients within the acute phase of disease	Peripheral blood test	Patients within 24 hours after onset

Primary Outcome Measures

Name	Time	Method
Rate of Surviving or Died Participants with sepsis	Day 90	Prognosis

Secondary Outcome Measures

Name	Time	Method
Sepsis-associated liver injury	Day 0	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）
Sepsis-associated kidney injury	Day 0	Concentration of Creatinine(Cr)\>2 mg/dl or Urine output \< 500ml/Day

Trial Locations

Locations (1)

The First Affillated Hospital,the Air Force Medical University; 🇨🇳 Xi'an, Shannxi, China