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Набор скоро начнётся NCT06279884

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

Наблюдательное Liver Transplantation Transplant Recipients

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Liver Transplantation, Transplant Recipients. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Secondary Infections in liver transplant recipients at 4 weeks [Срок оценки: 4 weeks]
  • quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks [Срок оценки: 4 weeks]
Вторичные конечные точки (4)
  • Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection [Срок оценки: 8 weeks]
  • Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection [Срок оценки: 12 weeks]
  • qSOFA score at 8 weeks [Срок оценки: 8 weeks]
  • qSOFA score at 12 weeks [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06279884 · 2023YFC2308802-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗