A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorZhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Liver transplant recipients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
4 weeks2
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.
Time frame
4 weeksSecondary outcomes
1
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.
Time frame
8 weeks2
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.
Time frame
12 weeks3
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.
Time frame
8 weeks4
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.
Time frame
12 weeksLocations
Sponsors and contacts
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Zhejiang University
Lead sponsor
Beijing Ditan Hospital
Collaborator
Beijing YouAn Hospital
Collaborator
Huashan Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: