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NCT Number: NCT06279884

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Secondary Infections in liver transplant recipients at 4 weeks

    Time frame: 4 weeks

    Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.

  2. quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks

    Time frame: 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.

Secondary outcomes

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

    Time frame: 8 weeks

    Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.

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

    Time frame: 12 weeks

    Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.

  3. qSOFA score at 8 weeks

    Time frame: 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.

  4. qSOFA score at 12 weeks

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajia Chen

CONTACT

[email protected]

+8615967109232

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

  • Beijing Ditan Hospital
  • Beijing YouAn Hospital
  • Huashan Hospital
  • Qilu Hospital of Shandong University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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