Anti-infection Therapy Based on mNGS Etiological Diagnosis and Infection After Liver Transplantation

ConditionInfection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorShenzhen Third People's Hospital

About this trial

Liver transplantation is the most efficacious treatment for end-stage liver disease; however, postoperative infection remains a major complication and leading cause of recipient mortality. Specifically, infections originating from donors, particularly those caused by multidrug-resistant bacteria, can significantly impact the prognosis of liver transplant recipients. Theoretically, implementing targeted antimicrobial therapy for donors prior to organ donation could reduce the likelihood of pathogen transmission with the transplanted organ, thereby potentially decreasing the incidence of post-transplant infections from donor sources and improving recipient outcomes. Nevertheless, there is currently a dearth of high-quality prospective studies in this domain. Our previous investigation (Front Microbiol. 2022 Jul 1;13:919363) demonstrated that second-generation metagenomic sequencing (mNGS) technology holds substantial value in expeditious pathogen screening following liver transplantation. Prompt implementation of targeted treatment based on microbiological findings has shown potential to enhance outcomes for select recipients. Therefore, this study aims to provide tailored treatment for donors based on microbiological examination results (including mNGS detection and culture results), analyze corresponding data regarding recipient infection occurrence and prognosis, and explore the impact of mNGS-guided donor antimicrobial therapy on perioperative infection rates among liver transplant recipients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recipient age >18 years;

Clinical diagnosis of infection in the donor with administered anti-infective treatment;

Complete clinical data for both the donor and recipient.

Disqualifiers

Recipient age <18 years;

Presence of surgery-related factors leading to death or infection, such as intraoperative cardiac arrest resulting in postoperative death, intraoperative bleeding exceeding 2000ml, postoperative complications like intestinal or bile leakage, graft dysfunction, or small liver syndrome;

Incomplete clinical data for the donor or recipient

Trial population

Patients treated with Liver transplantation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • mNGS

    Diagnostic test

    metagenomics next generation sequencing

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: donor-mNGS-testing group1 intervention
Group B: donor-non-mNGS-testing group0 interventions

Trial outcomes

Primary outcomes

1

Infection

The diagnosis of infection relies on a comprehensive assessment of clinical manifestations, microbiological test results, imaging examinations, and related laboratory tests. In our study, this diagnosis was established by a team of infectious disease specialists and organ transplant physicians. Donor-derived infection occurs when pathogens present in the donor's body post-organ procurement lead to the recipient contracting an infection with the same pathogens during the organ transplantation process.

Time frame
The study focused on the incidence of infection and the postoperative prognosis of transplant recipients within 30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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