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The Early Warning Mechanism and Establishment of Standardized Diagnosis and Treatment System of Urosepsis Combined with Upper Urinary Tract Calculi

The Early Warning Mechanism and Establishment of Standardized Diagnosis and Treatment System of Urosepsis Combined with Upper Urinary Tract Calculi

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000037855
Enrollment
Unknown
Registered
2020-09-02
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-09

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

Conditions

Urosepsis

Interventions

Gold Standard:Urosepsis can be diagnosed if:European diagnostic criteria for sepsis Sepsis 3.0
Sequential organ failure score in patients with infection or suspected infection(SOFA)>= 2
Quick SOFA(qSOFA) >= 2.
Index test:Heparin-binding&#32
protein
&#32
Serum&#32
A&#32

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patients with renal and / or ureteral calculi confirmed by imaging examination were treated with minimally invasive surgery (percutaneous nephrolithotomy / rigid ureteroscopy / flexible ureteroscopy). 2. Patients without bloodstream infection / urinary sepsis before operation: no fever, white blood cell and neutrophil ratio in normal range. 3. The patients whose urinary tract infection had been controlled before operation met the requirements of endovascular minimally invasive surgery: urinary WBC count < 50 / µ L. (if complicated with pyonephrosis, adequate drainage and anti infective treatment should be taken before operation.) 4. Patients without systemic infection before operation, such as pneumonia, biliary tract infection, enteritis, soft tissue infection, etc.

Exclusion criteria

Exclusion criteria: 1. Patients with urinary tract special pathogen infection, such as urinary tuberculosis infection, anaerobic bacteria infection, extensively drug-resistant bacterial infection, etc. 2. Patients with serious mental illness. 3. Patients with untreated malignant tumor or immune system diseases. 4. Patients with long-term use of immunosuppressants or glucocorticoids. 5. Patients with severe organ dysfunction. 6. Subjects of pregnancy.

Design outcomes

Primary

MeasureTime frame
Heparin-binding protein;Serum amyloid A protein;Presepsin;interleukin-6;Soluble urokinase-type plasminogen activator receptor;Soluble triggering receptor expressed on myeloid cells-1;CD64;SEN, SPE, ACC, AUC of ROC;

Secondary

MeasureTime frame
C-reactive protein;procalcitonin;

Countries

China

Contacts

Public ContactZhong Wu

Huashan Hospital Affiliated to Fudan University

drzhongwu1964@126.com+86 21-52887080

Outcome results

None listed

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