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

Recruiting

• Conditions: Sepsis; Bloodstream Infections; Critically Ill Intensive Care Unit Patients

• Registration Number: NCT06791889
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Study Start: 2024-09-15
• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-19
• Study First Posted: 2025-01-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
28-day mortality	Survival status at 28 days after the first diagnosis of sepsis on admission to the ICU

Trial Locations

Locations (1)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China