A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection
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: Liver Transplantation, Transplant Recipients. Basic parameters: 18 years — 70 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
- Center list to be confirmed — check the primary protocol.
- 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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Official title
A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection
Overview
The goal of this observational study is to map the pathogen profile of secondary infections in liver transplant recipients, to correlate the basic immune status with the characteristics of the secondary infection pathogen profile, and to establish an early warning system for monitoring secondary infections, so as to explore safe and effective therapeutic modalities to further reduce the morbidity and mortality of liver failure. The main questions it aims to answer are: * Characterize the distribution of pathogenic bacteria infecting liver transplant recipients. * Establish a monitoring and early warning system for secondary infections.
Detailed description
Liver transplantation is recognized as the most effective treatment for end-stage liver disease, and China's liver transplantation technology has reached the international level, with survival rates of 90%, 80%, and 70% at 1, 5, and 10 years after surgery, respectively. During the perioperative period of liver transplantation, transplant recipients with preoperative organ dysfunction, high surgical trauma, postoperative application of immunosuppressive drugs, and low anti-infective capacity are highly susceptible to associated infections, which are more likely to occur than in other transplant recipients, and have become an important factor affecting the prognosis of liver transplantation. Foreign studies reported that 18% of postoperative liver transplantation deaths were caused by infections, of which bacterial infections were the most common, followed by viral and fungal infections. In the first month after liver transplantation, the incidence of infection is the highest, and bacterial pneumonia is the most common infection, with a high case fatality rate, and the hospitalization time of the patient is significantly prolonged, and the economic expenditure is increased. Early clarification of the type and distribution of pathogenic bacteria infecting liver transplant recipients and prompt initiation of appropriate anti-infective therapy are essential to improve the survival of liver transplant recipients.
Primary outcome measures
- Secondary Infections in liver transplant recipients at 4 weeks [Time frame: 4 weeks]
- quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks [Time frame: 4 weeks]
Secondary outcome measures (4)
- Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection [Time frame: 8 weeks]
- Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection [Time frame: 12 weeks]
- qSOFA score at 8 weeks [Time frame: 8 weeks]
- qSOFA score at 12 weeks [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- Agree to participate in this study and sign the informed consent form;
- Be of any gender and aged 18-70 years old;
- No life-threatening underlying diseases and complications during the perioperative period.
- Undergo liver transplantation within 24 hours.
Exclusion criteria
1.Patients deemed unsuitable by the investigator to participate in the study.
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
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06279884 · 2023YFC2308802-03