Liver Transplantation Clinical Trial
Official title:
A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection
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.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | November 2026 |
Est. primary completion date | November 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Zhejiang University | Beijing Ditan Hospital, Beijing YouAn Hospital, Huashan Hospital, Qilu Hospital of Shandong University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Secondary Infections in liver transplant recipients at 4 weeks | Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results. | 4 weeks | |
Primary | quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks | qSOFA consists of 3 items: altered state of consciousness, systolic blood pressure = 100 mmHg, and respiratory rate = 22 respirations/min. 2 or more items, i.e., a qSOFA score of = 2, are considered to be suspicious for sepsis.Higher qSOFA scores are associated with a higher risk of patient death. | 4 weeks | |
Secondary | Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection | Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results. | 8 weeks | |
Secondary | Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection | Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results. | 12 weeks | |
Secondary | qSOFA score at 8 weeks | qSOFA consists of 3 items: altered state of consciousness, systolic blood pressure = 100 mmHg, and respiratory rate = 22 respirations/min. 2 or more items, i.e., a qSOFA score of = 2, are considered to be suspicious for sepsis.Higher qSOFA scores are associated with a higher risk of patient death. | 8 weeks | |
Secondary | qSOFA score at 12 weeks | qSOFA consists of 3 items: altered state of consciousness, systolic blood pressure = 100 mmHg, and respiratory rate = 22 respirations/min. 2 or more items, i.e., a qSOFA score of = 2, are considered to be suspicious for sepsis.Higher qSOFA scores are associated with a higher risk of patient death. | 12 weeks |
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