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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Kidney Injury; Prognosis; Liver Injury; Early Waking
• Intervention / Treatment: Diagnostic test: Peripheral blood test

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Wen Yin; Phone Number: 86 13809186660; Email: xjyyyw@126.com
• Study Contact Backup: Name: Shanshou Liu; Phone Number: 86 15091332280; Email: shanshouliu@126.com

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China, 710032
      • Recruiting
      • The First Affillated Hospital,the Air Force Medical University
      • Contact: Yanyan Jia; Phone Number: 029 84771794; Email: jiayanyan-2004@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

1. Healthy Volunteers;
2. Adult patients who meet the criteria for sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
3. Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Surviving or Died Participants with sepsis	Prognosis	Day 30
Rate of Surviving or Died Participants with sepsis	Prognosis	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Sepsis-associated kidney injury	Concentration of Creatinine(Cr)>2 mg/dl or Urine output < 500ml/Day	Day 0

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Yanyan Jia, The First Affillated Hospital,the Air Force Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 14, 2021
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 28, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Wounds and Injuries
• Other Study ID Numbers: KY20212172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No