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

NCT06279884 | Not Yet Recruiting

• 1 other identifier: 2023YFC2308802-03
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Transplantation; Transplant Recipients

Keywords

Liver Transplant Recipients; Infection; Pathogen spectrum; Cohort study

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection

  8 weeks

• Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection

  12 weeks

• qSOFA score at 8 weeks

  8 weeks

• qSOFA score at 12 weeks

  12 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Liver transplant recipients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead
• Beijing Ditan Hospital: collaborator
• Beijing YouAn Hospital: collaborator
• Huashan Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

According to the characteristics of infection, take blood or body fluids from the corresponding infected site.

MeSH Terms

Conditions

Infections

Study Officials

• Jiajia Chen

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiajia Chen

CONTACT

+8615967109232; Jiajiatale0@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of the First Affiliated Hospital,Zhejiang University School of Medicine

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-03