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Diagnostic Advantage of Droplet Digital PCR over Blood Culture in Sepsis: A Retrospective Study

The diagnostic value of digital droplet PCR in sepsis: A clinical evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109346
Enrollment
Unknown
Registered
2025-09-17
Start date
2025-09-18
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Spesis

Interventions

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age should be 14 years or older, and gender is not restricted; 2. Also meet the following requirements: (1) Meet the diagnostic criteria for sepsis: an increase of >= 2 points in the SOFA score or a qSOFA score of >= 2 points (early); Or in During the hospitalization, based on the patient's clinical manifestations and laboratory tests, a high suspicion of bloodstream infection was identified, which met the following conditions: There was a fever (>38?) or hypothermia (10.0×10^9/L) or decreased white blood cell count (<3.0×10^9/L), with systemic infection symptoms and signs such as neutrophil increase accompanied by nuclear left shift, and no other causes could explain it; 3). The systolic blood pressure was lower than 90 mmHg or decreased by more than 40 mmHg; (2). If conditions permit, ddPCR and blood culture tests can be conducted simultaneously.

Exclusion criteria

Exclusion criteria: People with mental disorders, pregnant women, and other special groups.

Design outcomes

Primary

MeasureTime frame
The sensitivity of digital PCR testing for patients with sepsis;The specificity of digital PCR testing for patients with sepsis;

Countries

China

Contacts

Public ContactWenjie Yang

Tianjin First Central Hospital

15516622620@163.com+86 136 0215 5376

Outcome results

None listed

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