Neutrophil extracellular net trap combined with sepsis biomarker diagnostic model

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300075812

Enrollment

Unknown

Registered

2023-09-15

Start date

2023-09-15

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

Gold Standard:Sepsis criteria (Sepsis3.0) : ?disorder of the body's response to infection and cause life-threatening organ dysfunction

? For ICU patients with suspected infection or infection, SOFA score increase of 2 points can be diagnosed

? For non-ICU patients with suspected infection or infection, qSOFA=2 points (systolic blood pressure =100 MMHG, respiratory rate =22 times/min, change of consciousness, 1 point for each one) can be d

Index test:Sepsis biomarker diagnostic model: ? To detect the expression of plasma cell-free DNA (cfDNA) in neutrophil extracellular net traps in patients with sepsis, and its sensitivity and specific

?To detect the expression of myeloperoxidase (MPO) in the neutrophil extracellular reticulum trap in septic patients, and its sensitivity and specificity

?detection in patients with sepsis neutrophils outer net trap to take off the amino acid acidification of histone H3 (Cit - H3) expression level, and its sensitivity and specificity. ?Traditional biom

Eligibility

Sex/Gender

All

Age

19 Years to 79 Years

Inclusion criteria

Inclusion criteria: Sepsis group inclusion criteria: (1) Patients admitted to the Department of Emergency and Intensive Care Unit of Sun Yi Memorial Hospital of Sun Yat-sen University from August 1, 2023 to July 31, 2024; (2) Age: 19-79 years old; (3) voluntarily participated in and signed the informed consent; (4) Sepsis criteria (Sepsis3.0) : for patients with infection or suspected infection, the diagnosis can be made when the patient's SOFA score increases by 2 points. Inclusion criteria for non-septic infection group: (1) Patients admitted to the Department of Emergency and Intensive Care Unit of Sun Yi Memorial Hospital of Sun Yat-sen University from August 1, 2023 to July 31, 2024; (2) Age 19-79 years old; (3) voluntarily participated in and signed the informed consent; (4) Postadmission clinical data to determine the presence of infection, including culture results, molecular testing (e.g., polymerase chain reaction, antigen), relevant imaging, and histopathological examination. (5) Did not meet the diagnostic criteria for sepsis (Sepsis3.0) : the patient's SOFA score increased by less than 2 points.

Exclusion criteria

Exclusion criteria: 1: cases without complete clinical data available from August 1, 2023 to July 31, 2024 2: pregnant or lactating women 3: Hospital stay less than 24 hours 4: cancer patients with end-stage malignancy or undergoing chemotherapy or radiotherapy at the time of presentation 5: HIV+ accompanied with CD4 count < 5×10000000/L, rheumatic disease or advanced disease (advanced blood disease, advanced respiratory disease, advanced liver and kidney failure) 6: Missing data 7: Inability to obtain informed consent or authorization.

Design outcomes

Primary

Measure	Time frame
Neutrophil extracellular net trap (NETs) markers (free DNA and/or myeloperoxidase (MPO) and/or deacidated aminoacidated histone H3 (Cit-H3)) combined with conventional markers (CRP and/or PCT and/or lactate);Neutrophil extracellular net trap (NETs) markers (free DNA and/or myeloperoxidase (MPO) and/or deacidated amino acidated histone H3 (Cit-H3)) combined with SOFA score;markers (free DNA and/or myeloperoxidase (MPO) and/or deacidated amino acidated histone H3 (Cit-H3)) combined with SOFA score and traditional markers (CRP and/or PCT and/or lactate);	—

Measure

Time frame

Neutrophil extracellular net trap (NETs) markers (free DNA and/or myeloperoxidase (MPO) and/or deacidated aminoacidated histone H3 (Cit-H3)) combined with conventional markers (CRP and/or PCT and/or lactate);Neutrophil extracellular net trap (NETs) markers (free DNA and/or myeloperoxidase (MPO) and/or deacidated amino acidated histone H3 (Cit-H3)) combined with SOFA score;markers (free DNA and/or myeloperoxidase (MPO) and/or deacidated amino acidated histone H3 (Cit-H3)) combined with SOFA score and traditional markers (CRP and/or PCT and/or lactate);

—

Secondary

Measure	Time frame
Length of hospital stay;duration of antibiotic use;28-day mortality;	—

Countries

China

Contacts

Public ContactFengqing Song

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

songfq@mail.sysu.edu.cn+86 183 4432 7768

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026