Fungal Infection, Intensive Care Medicine, Invasive Pulmonary Aspergillosis, Liver Cirrhosis, Viral Pneumonia
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Universitaire Ziekenhuizen KU Leuven
Gilead Sciences
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adults (≥ 18 years old) * Chronic liver disease * Admission to the Medical Intensive Care Unit of University Hospitals of Leuven
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IPA incidence | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical characteristics of IPA | From the date of ICU admission until ICU discharge, approximately 7 days | Baseline characteristics, organ failures, organ support, outcome parameters |
| Radiological characteristics of IPA | From the date of ICU admission until ICU discharge, approximately 7 days | Chest CT |
| Mycological characteristics of IPA | From the date of ICU admission until ICU discharge, approximately 7 days | Galactomannan testing, Aspergillus PCR, mycological culture |
| 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 | Through study completion, an average of 3 years | 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. |
| Histological characteristics of IPA using microbiological testing | Through study completion, an average of 3 years | 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. |
| Correlation of pre-mortem data with post-mortem lung tissue findings | Through study completion, an average of 3 years | — |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORJoost Wauters, MD, PhD
Universitaire Ziekenhuizen KU Leuven
Outcome results
None listed