Clinical Application of Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection: a Multicenter, Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 850
- Locations
- 1
- Primary Endpoint
- Positive rate of mNGS test in AD patients
Study Overview
Brief Summary
The goal of this observational study is to learn about clinical application of pathogenic metagenomic next-generation sequencing to optimize the diagnosis of infection in decompensated cirrhotic patients. The main questions it aims to answer are:
- mNGS testing in optimizing anti-infective drug use in patients with acute decompensation, including response to empiric antibiotic therapy.
- Proportion of patients with re-compensation.
- The positive rate of mNGS in patients with acute decompensated cirrhosis and the characteristics of pathogen.
- The incidence, risk factors and clinical correlation of CMV reactivation.
Detailed Description
Metagenomic next-generation sequencing (mNGS) is emerging as an important culture-independent technique that can detect nearly all known pathogens simultaneously from a clinical sample.Sequencing of microbial cell-free DNA (cfDNA) has recently been shown to enable diagnosis of several infection. Relevant studies on the clinical application of mNGS in cirrhosis patients are rare. The primary aim of this study was to comprehensively evaluate the fragments of genomic DNA from circulating microorganisms in acutely decompensated cirrhosis patients by sequencing the microbial cfDNA and relate this to clinical outcomes. The secondary aim was to validate the potential role of CMV reactivation, a known NHV with available antiviral medicines, in determining the prognosis of decompensated cirrhosis patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old.
- •Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not.
- •Acute decompensation: ascites, digestive hemorrhage or hepatic encephalopathy.
Exclusion Criteria
- •Age > 80 years old.
- •Malignancy of liver or other organs (including leukemia).
- •Receiving immunosuppressive agents for non-hepatic diseases.
- •HIV infection.
Outcomes
Primary Outcomes
Positive rate of mNGS test in AD patients
Time Frame: at enrolment
Secondary Outcomes
- 90-day transplantation-free mortality(From enrollment to 90 days)
- Incidence of acute kidney injury (AKI)(From enrollment to 90 days)
- Proportion of hospital readmissions due to infections(From enrollment to 90 days)
- Proportion of progression to SIRS or sepsis(From enrollment to 90 days)
- Consistency with blood culture results(at enrollment)
- Incidence of CMV reactivation(From enrollment to 90 days)
- Rate of progression to acute-on-chronic liver failure (ACLF)(From enrollment to 90 days)