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

NCT ID: NCT06791889

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-15

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Sepsis Bloodstream Infections Critically Ill Intensive Care Unit Patients

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ddPCR group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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You Shang, prof.

Role: CONTACT

008602785351606

Xiaobo Yang, prof.

Role: CONTACT

008602785351607

Facility Contacts

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Xiaobo Yang

Role: primary

Other Identifiers

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WHUICU202409

Identifier Type: -

Identifier Source: org_study_id

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