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

NCT06791889 | Recruiting

• 1 other identifier: WHUICU202409
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Bloodstream Infections; Critically Ill Intensive Care Unit Patients

Keywords

ddPCR; Sepsis; ICU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 28-day mortality

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

Study Arms (1)

ddPCR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to ICU

You may qualify if:

• Patients with first diagnosis of sepsis after ICU admission

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

You Shang, prof.

CONTACT

008602785351606; you_shanghust@163.com

Xiaobo Yang, prof.

CONTACT

008602785351607; want.tofly@aliyun.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: September 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)