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

NCT ID: NCT06212115

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2027-12-30

Brief Summary

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.

Detailed Description

Liver transplantation has been established as a highly effective treatment for end-stage liver disease, with continuous advancements in surgical techniques and immunosuppressive regimens significantly improving success rates and long-term survival for recipients. Despite these strides, postoperative challenges persist, with infections remaining a major complication and a leading cause of recipient mortality. Pathogens typically arise from the recipient's lungs, intestines, or other sites, yet donor-derived infections (DDIs), particularly those involving multidrug-resistant organisms, pose a substantial threat to transplant recipients' prognosis, prompting increased attention from liver transplant surgeons. Conventional microbial culture, with its lower positivity rate compared to metagenomic next-generation sequencing (mNGS), exhibits a limited ability to guide clinically targeted anti-infective treatment. Hence, the rapid and accurate identification of pathogens, coupled with early targeted anti-infective treatment, is pivotal for effective post-transplant infection management and DDI prevention. Theoretically, preemptive identification of microbiological diagnoses before organ donation, followed by targeted anti-infective treatment for the donor, holds the potential to diminish the risk of pathogens entering the recipient's body with the donated organ. This reduction may subsequently decrease the risk of post-transplant recipient infection originating from the donor, ultimately enhancing the recipient's prognosis. However, as of now, there is a dearth of relevant clinical research on this topic. Notably, our transplantation center employs mNGS to screen both donor and recipient pathogens, a method progressively gaining widespread clinical application. Through a comprehensive analysis of results from both detection methods, we implement targeted anti-infective treatment for both donors and recipients. Consequently, by analyzing cases of liver transplantation and their corresponding donor cases at our center, this study aims to investigate the impact of donor anti-infective treatment guided by mNGS microbiological diagnosis on the incidence of perioperative infections in recipients undergoing liver transplantation. The analysis encompasses the occurrence of infections, results of microbiological examinations, and the formulation of corresponding anti-infective treatment plans.

Conditions

Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

donor-mNGS-testing group

Organ donors are treated with mNGS testing before organ donation

mNGS

Intervention Type: DIAGNOSTIC_TEST

metagenomics next generation sequencing

donor-non-mNGS-testing group

Organ donors are not treated with mNGS testing before organ donation

No interventions assigned to this group

Interventions

mNGS

metagenomics next generation sequencing

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Third People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pusen Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong Zhao, Dr.

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Third People's Hospital

Locations

Shenzhen Third People's Hospital

Shenzhen, Shenzhen, China

Countries

China

Central Contacts

Dong Zhao, Dr.

Role: CONTACT

zdong1233@126.com

13631508530

Other Identifiers

SZSPH-LT-mNGS

Identifier Type: -

Identifier Source: org_study_id