Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06791889

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Sepsis Bloodstream Infections Critically Ill Intensive Care Unit Patients Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, China

Location status: Recruiting

Location contact

Xiaobo Yang

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Nucleic acid load of pathogenic bacteria at different time points

    Time frame: ''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 outcomes

  1. 28-day mortality

    Time frame: Survival status at 28 days after the first diagnosis of sepsis on admission to the ICU

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaobo Yang, prof.

CONTACT

[email protected]

008602785351607

You Shang, prof.

CONTACT

[email protected]

008602785351606

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.