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NCT Number: NCT07633366

BALance: ARDS Deconvolution by Bronchoalveolar Lavage Multiomics 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Vienna, Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Oliver Robak, Ap. Prof. Priv.-Doz. Dr.

CONTACT

[email protected]

+43 1 40400 44920

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sampling blood

Diagnostic Test

blood will be drawn from patients on day 1 and once a week until discharge/withdrawal/death

Lavage with physiologic saline solution

Diagnostic Test

mini-BALF using a physiologic saline soluation will be performed on day 1 and once a week until discharge/withdrawal/death

Other names: Mini-BALF

Primary outcomes

  1. ARDS phenotypes

    Time frame: 4 years

    The application of multi-omics cluster analysis to reveal any distinct ARDS phenotypes or subgroup-specific characteristics.

Secondary outcomes

  1. Lung Microbiome Composition Analysis via 16S rRNA Gene Sequencing of Bronchoalveolar Lavage (BAL) Fluid

    Time frame: 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

  2. Metabolomic Profile of Bronchoalveolar Lavage Fluid and Plasma

    Time frame: 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.

  3. Inflammatory Cytokine Profile in Bronchoalveolar Lavage Fluid and Plasma

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Oliver Robak, Prof. PD Dr.

CONTACT

[email protected]

+43 1 40400 44920

Riem Gawish, PhD

CONTACT

[email protected]

+43 1 40400 51480

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: BALance

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 8, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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