Идёт набор NCT06039696

Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection

— Наблюдательное Cirrhosis, Liver

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: Cirrhosis, Liver. Базовые параметры: 18 лет — 80 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: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical Application of Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection: a Multicenter, Prospective Study

Обзор

The goal of this observational study is to learn about clinical application of pathogenic metagenomic next-generation sequencing to optimize the diagnosis of infection in decompensated cirrhotic patients. The main questions it aims to answer are: 1. mNGS testing in optimizing anti-infective drug use in patients with acute decompensation, including response to empiric antibiotic therapy. 2. Proportion of patients with re-compensation. 3. The positive rate of mNGS in patients with acute decompensated cirrhosis and the characteristics of pathogen. 4. The incidence, risk factors and clinical correlation of CMV reactivation.

Подробное описание

Metagenomic next-generation sequencing (mNGS) is emerging as an important culture-independent technique that can detect nearly all known pathogens simultaneously from a clinical sample.Sequencing of microbial cell-free DNA (cfDNA) has recently been shown to enable diagnosis of several infection. Relevant studies on the clinical application of mNGS in cirrhosis patients are rare. The primary aim of this study was to comprehensively evaluate the fragments of genomic DNA from circulating microorganisms in acutely decompensated cirrhosis patients by sequencing the microbial cfDNA and relate this to clinical outcomes. The secondary aim was to validate the potential role of CMV reactivation, a known NHV with available antiviral medicines, in determining the prognosis of decompensated cirrhosis patients.

Первичные конечные точки

Positive rate of mNGS test in AD patients [Срок оценки: at enrolment]

Вторичные конечные точки (7)

90-day transplantation-free mortality [Срок оценки: From enrollment to 90 days]
Incidence of acute kidney injury (AKI) [Срок оценки: From enrollment to 90 days]
Proportion of hospital readmissions due to infections [Срок оценки: From enrollment to 90 days]
Proportion of progression to SIRS or sepsis [Срок оценки: From enrollment to 90 days]
Consistency with blood culture results [Срок оценки: at enrollment]
Incidence of CMV reactivation [Срок оценки: From enrollment to 90 days]
Rate of progression to acute-on-chronic liver failure (ACLF) [Срок оценки: From enrollment to 90 days]

Критерии участия

Критерии включения

Age ≥ 18 years old.
Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not.
Acute decompensation: ascites, digestive hemorrhage or hepatic encephalopathy.