Ignite Creation Date:
2025-12-18 @ 8:24 AM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT06212115
Status:
None
Last Update Posted:
2024-01-19 00:00:00
First Post:
2023-12-26 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-infection Therapy Based on mNGS Etiological Diagnosis and Infection After Liver Transplantation
Sponsor:
None
Organization:
Study Overview
Official Title:
The Effect of Donor-oriented Anti-infection Therapy Based on mNGS Etiological Diagnosis on the Incidence of Perioperative Infection and Prognosis of Corresponding Recipients After Liver Transplantation
Status:
None
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: