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Construction of an Early Sepsis Screening Model Based on Multidimensional Cellular Biophysical and Immunophenotypic Characteristics

Construction of an Early Sepsis Screening Model Based on Multidimensional Cellular Biophysical and Immunophenotypic Characteristics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122948
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Sepsis

Interventions

Sepsis group:None
Healthy control group:None
Non-septic infection group:None

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Group A criteria (200 patients) : patients were enrolled in the observational study if they met all of the following criteria: (1) age >=18 years old; (2) Initial screening (qSOFA >= 2 or high clinical suspicion of infection) in emergency department, hematology department and ICU; (3) Patients or their family members were able to understand the study protocol and willing to participate in the study, and provided written informed consent. Group B criteria (150 patients) : patients were enrolled in the observational study if they met all of the following criteria: (1) age >=18 years old; (2) Patients were diagnosed with infection in the emergency department, hematology department, and ICU without organ dysfunction (SOFA=18 years old; (2) good health without signs of infection;

Exclusion criteria

Exclusion criteria: Exclusion criteria: Patients could not be selected for clinical study if they had any of the following conditions: (1) Age: < 18 years old; (2) pregnant or lactating women; (3) severe immunosuppression: such as HIV/AIDS, long-term use of immunosuppressive agents, organ transplantation; (4) received blood transfusion or blood products within 1 year; (5) diagnosed hematological diseases, such as leukemia and lymphoma; (6) The samples did not meet the requirements, such as hemolysis, coagulation, blood collection time overtime, etc. (7) Inability to obtain informed consent.

Design outcomes

Primary

MeasureTime frame
Primary outcome: Diagnosis of sepsis according to Sepsis-3 criteria;Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-parameter Diagnostic Model;Laboratory test indicators:1. nCD64 Index; 2. Monocyte Distribution Width (MDW); 3. Neutrophil Stiffness (Deformability); 4. Cell Aspect Ratio; 5. Cell Subset Size Distribution;

Countries

China

Contacts

Public ContactYin Lu

Peking University Shenzhen Hospital

18334156@qq.com+86 755 83923333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026