Идёт набор NCT07633366

BALance: ARDS Deconvolution by Bronchoalveolar Lavage Multiomics and Radiomics

— Наблюдательное ARDS (Acute Respiratory Distress Syndrome)

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: В протоколе указаны: sampling blood, Lavage with physiologic saline solution.
Кому может быть актуально: Состояния в реестре: ARDS (Acute Respiratory Distress Syndrome). Базовые параметры: от 18 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: Австрия
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

Check the BALance: ARDS Deconvolution by Bronchoalveolar Lavage Multiomics Profiling and Radiomics

Обзор

Acute respiratory distress syndrome (ARDS) is a major contributor to ICU mortality and is characterised by hypoxaemia and pulmonary oedema. Pathomechanisms include barrier breakdown, immunopathology, haemostatic derailment and dysbiosis; however, the actual sequence of events and how they cumulatively lead to lung failure remains unclear. Although ARDS is frequently triggered by pneumonia, it can also occur as a result of trauma, aspiration or non-pulmonary causes. Importantly, ARDS is highly heterogeneous; growing evidence points to aetiology-specific pathomechanisms - a circumstance that explains why attempts to develop specific drugs or timely diagnostic markers have so far failed. A comprehensive analysis of key microenvironmental and haemostasis-related parameters of the lung, combined with multidimensional quantitative image features derived from chest CT scans (radiomics), will enable us to i) identify ARDS phenotypes with different biological characteristics and ii) generate new hypotheses regarding aetiology- or subgroup-specific mechanisms, molecular markers and therapeutic options. Our approach is based on ICU management of our patients guided by bronchoalveolar lavage fluid (BALF). Together with previously sampled cases and new samples collected as part of this study, our cohort will consist of patients with i) COVID-19-associated ARDS, ii) ARDS associated with other viral pneumonia, iii) ARDS associated with bacterial pneumonia, and iv) ARDS of non-pulmonary origin. Bacterial and fungal co-infections and superinfections are recorded in all patients and taken into account in the stratification. Patients with pneumonia without ARDS, as well as ventilated patients without underlying lung disease, serve as controls. To characterise the microbial lung microenvironment, the investigators combine data from routine microbiological diagnostics with microbiome sequencing and metabolomics. In addition, the investigators conduct comprehensive and longitudinal immune and haemostatic profiling by regularly analysing immune cells, cytokines and parameters of immune thrombosis in BALF and blood. Multi-omics integration then identifies phenotypic subgroups by merging all multimodal datasets - including radiomics. Selected samples from identified clusters are then further characterised using single-cell sequencing to uncover specific features/markers and pathomechanisms of the respective ARDS subtypes. Although it is clear that the pathogenesis of ARDS is multifactorial, comprehensive studies that integrate all relevant parameters are rare. Radiomics is increasingly recognised as a powerful tool for capturing the clinical status of ARDS in detail; however, to date, this imaging data has not been systematically linked to other omics readouts. The investigators aim to bridging this gap by conducting a thorough investigation across various ARDS aetiologies in the present study, incorporating all identifiable key factors. Our interdisciplinary team comprises basic immunologists, infectious disease and computational biologists, as well as clinicians with expertise in ARDS, infectious diseases, immunothrombosis and radiology.

Вмешательства

Диагностический тест sampling blood
blood will be drawn from patients on day 1 and once a week until discharge/withdrawal/death
Диагностический тест Lavage with physiologic saline solution
mini-BALF using a physiologic saline soluation will be performed on day 1 and once a week until discharge/withdrawal/death

Первичные конечные точки

ARDS phenotypes [Срок оценки: 4 years]

Вторичные конечные точки (3)

Lung Microbiome Composition Analysis via 16S rRNA Gene Sequencing of Bronchoalveolar Lavage (BAL) Fluid [Срок оценки: 4 years]
Metabolomic Profile of Bronchoalveolar Lavage Fluid and Plasma [Срок оценки: 4 years]
Inflammatory Cytokine Profile in Bronchoalveolar Lavage Fluid and Plasma [Срок оценки: 4 years]

Критерии участия

Критерии включения

male and female
aged 18 years or over
signed consent form
depending on the study group: Confirmed ARDS according to the Berlin criteria (see below, Groups B and D) Confirmed severe CAP requiring mechanical ventilation and intensive care (see below, Groups B and C) Ventilated patients without signs of ARDS (see below, Group E)