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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05229328
• Other study ID #: KY20212172
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Early Waking
• Kidney Injury
• Liver Injury
• Prognosis
• Sepsis
• Wounds and Injuries

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