Clinical trial NCT06279884: A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection
Official title: A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Transplantation
Transplant Recipients
Keywords: Liver Transplant Recipients
Infection
Pathogen spectrum
Cohort study
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Beijing Ditan Hospital
name: Beijing YouAn Hospital
name: Huashan Hospital
name: Qilu Hospital of Shandong University
First posted: 2024-02-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver transplant recipients

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Agree to participate in this study and sign the informed consent form;
2. Be of any gender and aged 18-70 years old;
3. No life-threatening underlying diseases and complications during the perioperative period.
4. Undergo liver transplantation within 24 hours.

Exclusion Criteria:

1.Patients deemed unsuitable by the investigator to participate in the study.

Primary outcomes:
measure: Secondary Infections in liver transplant recipients at 4 weeks
timeFrame: 4 weeks
measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection
timeFrame: 8 weeks
measure: Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection
timeFrame: 12 weeks
measure: qSOFA score at 8 weeks
timeFrame: 8 weeks
measure: qSOFA score at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang University
name: Jiajia Chen
role: PRINCIPAL_INVESTIGATOR
References: