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

NCT ID: NCT05229328

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-26

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Sepsis Prognosis Liver Injury Kidney Injury Early Waking

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

Healthy volunteers

Peripheral blood test

Intervention Type 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

Patients within the acute phase of disease

Patients within 24 hours after onset

Peripheral blood test

Intervention Type 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

Recovery phase of disease

Inflammation was controlled, shock was corrected, and the patient remained fever free for 3 consecutive days.

Peripheral blood test

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yanyan Jia

Role: STUDY_CHAIR

The First Affillated Hospital,the Air Force Medical University

Locations

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The First Affillated Hospital,the Air Force Medical University

Xi'an, Shannxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wen Yin

Role: CONTACT

13809186660 ext. 86

Shanshou Liu

Role: CONTACT

15091332280 ext. 86

Facility Contacts

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Yanyan Jia

Role: primary

84771794 ext. 029

Other Identifiers

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KY20212172

Identifier Type: -

Identifier Source: org_study_id

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