Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- IPA incidence
研究概览
简要总结
Invasive pulmonary aspergillosis (IPA) is a life-threatening fungal infection of the respiratory system, caused by a specific fungus called Aspergillus species. It is already known that patients with a weakened immune system are at higher risk of developing this disease. Recently, it has also been shown that patients with viral pneumonia (such as influenza or COVID-19) and patients with liver cirrhosis who are admitted to the intensive care unit are also vulnerable to this infection.
This study aims to better define the epidemiology, clinical risk factors, outcomes, and treatment of IPA in ACLF patients admitted to the ICU. By combining clinical data with histological findings from autopsies, the study seeks to improve diagnostic accuracy, risk prediction, and timely initiation of antifungal therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults (≥ 18 years old)
- •Chronic liver disease
- •Admission to the Medical Intensive Care Unit of University Hospitals of Leuven
排除标准
- •Patients < 18 years
- •Recent history of invasive pulmonary aspergilosis and/or invasive candidiasis (<1 month before ICU admission) and/or active treatment for IPA and/or invasive candidiasis
研究组 & 干预措施
ICU patients with liver cirrhosis and IPA
The study population includes patients with confirmed or suspected liver cirrhosis who were admitted to the Medical ICU of UZ Leuven.
Invasive pulmonary aspergillosis (IPA) is a life-threatening fungal infection, historically seen in severely immunocompromised patients. In recent years, it has also been increasingly recognized in ICU patients without classic immunosuppression, including those with viral pneumonia (e.g., influenza, COVID-19) and those with liver cirrhosis and acute-on-chronic liver failure (ACLF).
ICU patient with liver cirrhosis without IPA
The study population consists of patients with known or suspected liver cirrhosis who were admitted to the Medical ICU of UZ Leuven.
结局指标
主要结局
IPA incidence
时间窗: From the date of ICU admission until ICU discharge, approximately 7 days
The incidence of proven invasive pulmonary aspergillosis (IPA) in critically ill cirrhotic patients will be assessed. Routinely used biochemical and microbiological tests (such as galactomannan and Aspergillus PCR) will be performed on blood and BAL samples stored in the biobank to identify affected patients.
Identifying whether ACLF is an independent risk factor for IPA in EORTC-negative critically ill patients
时间窗: From the date of ICU admission until ICU discharge, approximately 7 days
The occurrence of IPA will be compared between an ACLF EORTC-negative cohort and a non-ACLF cohort
次要结局
- Clinical characteristics of IPA(From the date of ICU admission until ICU discharge, approximately 7 days)
- Radiological characteristics of IPA(From the date of ICU admission until ICU discharge, approximately 7 days)
- Mycological characteristics of IPA(From the date of ICU admission until ICU discharge, approximately 7 days)
- Impact of IPA on ICU mortality(From the date of ICU admission until ICU discharge, approximately 7 days)
- Impact of IPA on hospital mortality(From the date of ICU admission until hospital discharge, approximately 36 days)
- Impact of IPA on 90-day mortality(From ICU admission until 90 days post-admission)
- Impact of IPA on liver transplant eligibility(From the date of ICU admission until ICU discharge, approximately 7 days)
- Histological characteristics of IPA using tissue staining(Through study completion, an average of 3 years)
- Histological characteristics of IPA using microbiological testing(Through study completion, an average of 3 years)
- Correlation of pre-mortem data with post-mortem lung tissue findings(Through study completion, an average of 3 years)
- Impact of IPA on length of ICU stay(From the date of ICU admission until ICU discharge, approximately 7 days)
- Impact of IPA on length of hospital stay(From the date of ICU admission until hospital discharge, approximately 36 days)
- Impact of IPA on mortality(From ICU admission until 90 days post-admission)
- Impact of IPA on liver transplant delisting(From the date of ICU admission until ICU discharge, approximately 7 days)