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

NCT05229328 | Unknown

• 1 other identifier: KY20212172
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Prognosis; Liver Injury; Kidney Injury; Early Waking

Outcome Measures

Primary Outcomes (2)

• Rate of Surviving or Died Participants with sepsis

  Prognosis

  Day 30

• Rate of Surviving or Died Participants with sepsis

  Prognosis

  Day 90

Secondary Outcomes (2)

• Sepsis-associated liver injury

  Day 0

• Sepsis-associated kidney injury

  Day 0

Study Arms (3)

Control group

Healthy volunteers

Diagnostic Test: Peripheral blood test

Patients within the acute phase of disease

Patients within 24 hours after onset

Diagnostic Test: Peripheral blood test

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

Interventions

Peripheral blood test DIAGNOSTIC_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

Control group; Patients within the acute phase of disease; Recovery phase of disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affillated Hospital,the Air Force Medical University

Xi'an, Shannxi, 710032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, PBMC, plasma exosome miRNA

MeSH Terms

Conditions

Sepsis; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Yanyan Jia

  The First Affillated Hospital,the Air Force Medical University

  STUDY CHAIR

Central Study Contacts

Wen Yin

CONTACT

13809186660; xjyyyw@126.com

Shanshou Liu

CONTACT

15091332280; shanshouliu@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: February 8, 2022
• Study Start: October 26, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 31, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)