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Research on a rapid and accurate diagnostic method for catheter-related bloodstream infections based on loop-mediated isothermal amplification combined with microfluidic technology

Research on a rapid and accurate diagnostic method for catheter-related bloodstream infections based on loop-mediated isothermal amplification combined with microfluidic technology

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115298
Enrollment
Unknown
Registered
2025-12-24
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Catheter-related bloodstream infection

Interventions

Gold Standard:Blood culture results
Index test:The results of blood culture and the detection of target pathogenic bacteria using the loop-mediated isothermal amplification microfluidic chip

Sponsors

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. Central venous catheter (such as subclavian vein catheter, internal jugular vein catheter, femoral vein catheter, etc.) is in place; 3. Present with suspected bloodstream infection clinical manifestations such as fever (body temperature >= 38.0?) or hypothermia (body temperature <= 36.0?), chills, hypotension (systolic blood pressure < 90mmHg), etc., and the doctor has prescribed blood culture test instructions; 4. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Within the past 3 days, adequate and effective antibacterial drugs have been administered for the treatment of bloodstream infection, and the clinical symptoms have significantly improved; 2. There is severe coagulation dysfunction (such as platelet count 2.0, etc.), making blood sample collection impossible; 3. Suffering from mental illness or cognitive impairment, unable to cooperate with the relevant research operations and follow-up; 4. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Specificity;Sensitivity;Positive predictive value;Negative predictive value;Youden Index;degree of accuracy;

Countries

China

Contacts

Public ContactCao Jie

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

celion2004@126.com+86 138 1779 7641

Outcome results

None listed

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