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| ID | Type | Description | Link |
|---|---|---|---|
| IN-BE-131-7804 | Other Grant/Funding Number | Gilead Sciences |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| IPA incidence | 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. | From the date of ICU admission until ICU discharge, approximately 7 days |
| Identifying whether ACLF is an independent risk factor for IPA in EORTC-negative critically ill patients | The occurrence of IPA will be compared between an ACLF EORTC-negative cohort and a non-ACLF cohort | From the date of ICU admission until ICU discharge, approximately 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical characteristics of IPA | Baseline characteristics, organ failures, organ support, outcome parameters | From the date of ICU admission until ICU discharge, approximately 7 days |
| Radiological characteristics of IPA |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients with known or suspected liver cirrhosis who were admitted to the Medical ICU of UZ Leuven.
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| Name | Affiliation | Role |
|---|---|---|
| Joost Wauters, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Belgium |
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Chest CT
| From the date of ICU admission until ICU discharge, approximately 7 days |
| Mycological characteristics of IPA | Galactomannan testing, Aspergillus PCR, mycological culture | From the date of ICU admission until ICU discharge, approximately 7 days |
| 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 eligibility | From the date of ICU admission until ICU discharge, approximately 7 days |
| Impact of IPA on liver transplant delisting | From the date of ICU admission until ICU discharge, approximately 7 days |
| Histological characteristics of IPA using tissue staining | Histological characteristics of IPA in critically ill cirrhotic patients will be analyzed. Additional histological staining (e.g., Grocott stain) will be performed to detect fungal hyphae. | Through study completion, an average of 3 years |
| Histological characteristics of IPA using microbiological testing | Histological characteristics of IPA in critically ill cirrhotic patients will be analyzed. Additional microbiological testing (e.g., Aspergillus PCR) will be performed to detect fungal hyphae. | 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 |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D011024 | Pneumonia, Viral |
| D009181 | Mycoses |
| D055744 | Invasive Pulmonary Aspergillosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001423 | Bacterial Infections and Mycoses |
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D000072742 | Invasive Fungal Infections |
| D008172 | Lung Diseases, Fungal |
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