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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06279884
Other study ID # 2023YFC2308802-03
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2024
Est. completion date November 2026

Study information

Verified date March 2024
Source Zhejiang University
Contact Jiajia Chen
Phone +8615967109232
Email Jiajiatale0@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Zhejiang University Beijing Ditan Hospital, Beijing YouAn Hospital, Huashan Hospital, Qilu Hospital of Shandong University

Outcome

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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