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BALance: ARDS Deconvolution by Bronchoalveolar Lavage Multiomics and Radiomics (BALance)

2026年7月8日 更新者:Oliver Robak、Medical University of Vienna

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

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

130

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • State of Vienna
      • Vienna、State of Vienna、奥地利、1090
        • 招聘中
        • General Hospital of Vienna, Medical University of Vienna
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

All patients admitted to the University Hospitals of the Medical University of Vienna at the Vienna General Hospital (AKH Vienna) during the specified study period who meet the inclusion criteria will be enrolled in this study.

描述

Inclusion Criteria:

  • 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)

Exclusion Criteria:

- under 18 years of age

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
COVID-19 ARDS
blood will be drawn from patients on day 1 and once a week until discharge/withdrawal/death
mini-BALF using a physiologic saline soluation will be performed on day 1 and once a week until discharge/withdrawal/death
其他名称:
  • Mini-BALF
Pneumonia-induced ARDS
blood will be drawn from patients on day 1 and once a week until discharge/withdrawal/death
mini-BALF using a physiologic saline soluation will be performed on day 1 and once a week until discharge/withdrawal/death
其他名称:
  • Mini-BALF
Severe pneumonia but no ARDS
blood will be drawn from patients on day 1 and once a week until discharge/withdrawal/death
mini-BALF using a physiologic saline soluation will be performed on day 1 and once a week until discharge/withdrawal/death
其他名称:
  • Mini-BALF
Non-pulmonary origin ARDS
blood will be drawn from patients on day 1 and once a week until discharge/withdrawal/death
mini-BALF using a physiologic saline soluation will be performed on day 1 and once a week until discharge/withdrawal/death
其他名称:
  • Mini-BALF
No lung pathology
blood will be drawn from patients on day 1 and once a week until discharge/withdrawal/death
mini-BALF using a physiologic saline soluation will be performed on day 1 and once a week until discharge/withdrawal/death
其他名称:
  • Mini-BALF

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
ARDS phenotypes
大体时间:4 years
The application of multi-omics cluster analysis to reveal any distinct ARDS phenotypes or subgroup-specific characteristics.
4 years

次要结果测量

结果测量
措施说明
大体时间
Lung Microbiome Composition Analysis via 16S rRNA Gene Sequencing of Bronchoalveolar Lavage (BAL) Fluid
大体时间:4 years
Differences in the microbial community composition (alpha diversity, beta diversity, and taxonomic abundance at phylum/genus level) of the lower respiratory tract microbiome in intensive care patients with ARDS
4 years
Metabolomic Profile of Bronchoalveolar Lavage Fluid and Plasma
大体时间:4 years
Differences in the metabolomic profile (relative concentrations of annotated metabolites and pathway-level scores) in bronchoalveolar lavage (BAL) fluid and plasma between ARDS subgroups (with vs. without bacterial/fungal co-/superinfection). Metabolomic measurements will be performed using the METAB02, AMINO01, and LIPID01 or other appropriate packages. Samples will be analyzed via mass spectrometry to quantify a wide range of analytes, including various amino acids, lipids and their subclasses, and metabolites such as pyruvate, lactate, citrate, and succinate.
4 years
Inflammatory Cytokine Profile in Bronchoalveolar Lavage Fluid and Plasma
大体时间:4 years
Concentrations of predefined pro- and anti-inflammatory cytokines (e.g., IL-6, IL-8, TNF-α, others according to panel) in BAL fluid and plasma of ARDS patients, and detection of differences between ARDS subgroups (with vs. without bacterial/fungal co-/superinfection) by Multiplex bead-based immunoassay or ELISA panels (e.g., Luminex, electrochemiluminescence).
4 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 研究主任:Oliver Robak, Prof. PD Dr.、Medical University of Vienna, Department of Medicine 1
  • 首席研究员:Riem Gawish, PhD、Medical University of Vienna, Department of Medicine 1

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2029年6月1日

研究完成 (估计的)

2030年6月1日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2405/2025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

We plan to share de-identified individual participant data (IPD) underlying the results reported in this study, including demographic data, baseline characteristics, and outcome measures. Data will be available following publication of the primary results, upon reasonable request from qualified researchers.

IPD 共享时间框架

4 years, starting from enrollment

IPD 共享访问标准

Access will be granted after approval of a methodologically sound proposal and completion of a data sharing agreement, in compliance with institutional and data protection regulations.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

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