CClinicalTrials.gg
Status unknownNCT05229328Updated Jan 31, 2023

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

An observational study in Sepsis, Prognosis and Liver Injury, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-31.

Sponsored by Xijing Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sepsis
  • Prognosis
  • Liver Injury
  • Kidney Injury
  • Early Waking
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 458 are open to participants now.

This study's planned enrollment of 300 is above the median of 160 across 929 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Diagnostic testPeripheral 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

06

What researchers measure

Primary outcomes

  1. Rate of Surviving or Died Participants with sepsis

    Prognosis

    Time frame: Day 30

  2. Rate of Surviving or Died Participants with sepsis

    Prognosis

    Time frame: Day 90

Secondary outcomes

  1. 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)

    Time frame: Day 0

  2. Sepsis-associated kidney injury

    Concentration of Creatinine(Cr)\>2 mg/dl or Urine output \< 500ml/Day

    Time frame: Day 0

07

Study locations

1 of 1 sites recruiting
  • The First Affillated Hospital,the Air Force Medical University
    Xi'an, Shannxi 710032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05229328
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Feb 8, 2022
Start date
Oct 26, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jan 31, 2023

Study contacts

Wen Yin
Contact
xjyyyw@126.com
13809186660 ext. 86
Shanshou Liu
Contact
shanshouliu@126.com
15091332280 ext. 86
Yanyan Jia
study chair · The First Affillated Hospital,the Air Force Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion