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ARDS (Acute Respiratory Distress Syndrome)BALanceNCT07633366

BALance: ARDS Deconvolution by Bronchoalveolar Lavage Multiomics and Radiomics

An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Medical University of Vienna at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
sampling blood and Lavage with physiologic saline solution
How many people
130 participants
Where
1 siteAustria
Study dates
Jul 2026to 1 Jun 2030
How long will I take part?
4 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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)

Who cannot join

  • under 18 years of age

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Austria1 site, 1 recruiting
  • General Hospital of Vienna, Medical University of Vienna

    Vienna, State of Vienna, 1090

    Oliver Robak, Ap. Prof. Priv.-Doz. Dr., +43 1 40400 44920, oliver.robak@meduniwien.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: 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.

Read more

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.

Being tested
sampling blood, Lavage with physiologic saline solution
Keywords
ARDS, BALF, COVID-19, Influenza, Co-Infection, Pneumonia, viral, bacterial
Medical subject headings
Acute Lung Injury, COVID-19, Influenza, Human, Coinfection, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sampling bloodDiagnostic test

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

  • Lavage with physiologic saline solutionDiagnostic test

    Also called Mini-BALF

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

Study groups in NCT07633366
Study groupRoleWhat they receive
COVID-19 ARDSCOVID-19 ARDS
Receives: Diagnostic Test: sampling blood; Diagnostic Test: Lavage with physiologic saline solution
Pneumonia-induced ARDSPneumonia-induced ARDS
Receives: Diagnostic Test: sampling blood; Diagnostic Test: Lavage with physiologic saline solution
Severe pneumonia but no ARDSSevere pneumonia but no ARDS
Receives: Diagnostic Test: sampling blood; Diagnostic Test: Lavage with physiologic saline solution
Non-pulmonary origin ARDSNon-pulmonary origin ARDS
Receives: Diagnostic Test: sampling blood; Diagnostic Test: Lavage with physiologic saline solution
No lung pathologyNo lung pathology
Receives: Diagnostic Test: sampling blood; Diagnostic Test: Lavage with physiologic saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ARDS phenotypes

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

    Measured: 4 years

Secondary outcomes (3)
  1. Lung Microbiome Composition Analysis via 16S rRNA Gene Sequencing of Bronchoalveolar Lavage (BAL) Fluid

    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

    Measured: 4 years

  2. Metabolomic Profile of Bronchoalveolar Lavage Fluid and Plasma

    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.

    Measured: 4 years

  3. Inflammatory Cytokine Profile in Bronchoalveolar Lavage Fluid and Plasma

    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).

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completion1 Jun 2029 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
130 participants (estimated)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07633366
Sponsor's protocol ID
2405/2025
Acronym
BALance
Status last verified
Jul 2026
First submitted
11 May 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oliver Robak, Prof. PD Dr. (+43 1 40400 44920, oliver.robak@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ARDS phenotypes (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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