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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06279884
Enrollment
1000
Registered
2024-02-28
Start date
2024-03-31
Completion date
2026-11-30
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation, Transplant Recipients

Keywords

Liver Transplant Recipients, Infection, Pathogen spectrum, Cohort study

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.

Interventions

None listed

Sponsors

Beijing Ditan Hospital
CollaboratorOTHER
Beijing YouAn Hospital
CollaboratorOTHER
Huashan Hospital
CollaboratorOTHER
Qilu Hospital of Shandong University
CollaboratorOTHER
Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Secondary Infections in liver transplant recipients at 4 weeks4 weeksSite of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.
quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks4 weeksqSOFA 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.

Secondary

MeasureTime frameDescription
Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection8 weeksSite of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.
Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection12 weeksSite of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.
qSOFA score at 8 weeks8 weeksqSOFA 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.
qSOFA score at 12 weeks12 weeksqSOFA 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.

Contacts

Primary ContactJiajia Chen
Jiajiatale0@zju.edu.cn+8615967109232

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026