Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis, Bloodstream Infections, Critically Ill Intensive Care Unit Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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 outcome measures (1)
- 28-day mortality [Time frame: Survival status at 28 days after the first diagnosis of sepsis on admission to the ICU]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong Uni — Wuhan
Identifiers
NCT: NCT06791889 · WHUICU202409