A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection

Liver Transplantation Clinical Trial

Official title:

A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279884
• Other study ID #: 2023YFC2308802-03
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Infections
• Liver Transplantation
• Transplant Recipients

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