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Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study

Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06791889
Enrollment
60
Registered
2025-01-24
Start date
2024-09-15
Completion date
2025-12-31
Last updated
2025-03-17

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

Conditions

Bloodstream Infections, Critically Ill Intensive Care Unit Patients, Sepsis

Keywords

ddPCR, Sepsis, ICU

Brief summary

The purpose of this study is to investigate the efficacy of droplet digital PCR (ddPCR) in identifying pathogenic organisms in ICU sepsis patients, aiming to find a method that allows early identification of pathogenic organisms and dynamic surveillance in order to assess the association between pathogenic species and loads and clinical characteristics and outcomes.

Detailed description

This is a monocentric observational study. Patients admitted to the ICU with a first diagnosis of sepsis will be dynamically monitored for nucleic acid loads of pathogenic bacteria in the blood using ddPCR at different time points until the last blood sample is taken on day 28-30 or the patient is discharged from the ICU.

Interventions

None listed

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with first diagnosis of sepsis after ICU admission

Exclusion criteria

* Age under 18 years * Do not meet Sepsis 3.0 diagnostic criteria * Refusal to sign informed consent

Design outcomes

Primary

MeasureTime frame
Nucleic acid load of pathogenic bacteria at different time points''Nucleic acid load of pathogenic bacteria in the blood versus time'' could have a time frame of ''0, 2-3, 4-5, 6-7, 8-9, 10-12, 13-15, 20-22, 28-30 days post admission to the ICU with the first diagnosis of sepsis''.

Secondary

MeasureTime frame
28-day mortalitySurvival status at 28 days after the first diagnosis of sepsis on admission to the ICU

Countries

China

Contacts

Primary ContactYou Shang, prof.
you_shanghust@163.com008602785351606
Backup ContactXiaobo Yang, prof.
want.tofly@aliyun.com008602785351607

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026