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.
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
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- 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
- 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
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 group | Role | What they receive |
|---|---|---|
| COVID-19 ARDS | COVID-19 ARDS Receives: Diagnostic Test: sampling blood; Diagnostic Test: Lavage with physiologic saline solution | |
| Pneumonia-induced ARDS | Pneumonia-induced ARDS Receives: Diagnostic Test: sampling blood; Diagnostic Test: Lavage with physiologic saline solution | |
| Severe pneumonia but no ARDS | Severe pneumonia but no ARDS Receives: Diagnostic Test: sampling blood; Diagnostic Test: Lavage with physiologic saline solution | |
| Non-pulmonary origin ARDS | Non-pulmonary origin ARDS Receives: Diagnostic Test: sampling blood; Diagnostic Test: Lavage with physiologic saline solution | |
| No lung pathology | No 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.
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)
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
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
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.
- First posted8 Jun 2026
- Study startJul 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Robak, Medical University of Vienna
- Investigators
- Oliver Robak, Prof. PD Dr., Study director, Medical University of Vienna, Department of Medicine 1Riem Gawish, PhD, Principal investigator, Medical University of Vienna, Department of Medicine 1
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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Check the BALance: ARDS Deconvolution by Bronchoalveolar Lavage Multiomics Profiling and Radiomics
- ClinicalTrials.gov ID
- NCT07633366
- Acronym / sponsor ID
- BALance / 2405/2025
- Keywords
- ARDS, BALF, COVID-19, Influenza, Co-Infection, Pneumonia, viral, bacterial
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| COVID-19 ARDS | – | Diagnostic Test: sampling blood, Diagnostic Test: Lavage with physiologic saline solutionCOVID-19 ARDS |
| Pneumonia-induced ARDS | – | Diagnostic Test: sampling blood, Diagnostic Test: Lavage with physiologic saline solutionPneumonia-induced ARDS |
| Severe pneumonia but no ARDS | – | Diagnostic Test: sampling blood, Diagnostic Test: Lavage with physiologic saline solutionSevere pneumonia but no ARDS |
| Non-pulmonary origin ARDS | – | Diagnostic Test: sampling blood, Diagnostic Test: Lavage with physiologic saline solutionNon-pulmonary origin ARDS |
| No lung pathology | – | Diagnostic Test: sampling blood, Diagnostic Test: Lavage with physiologic saline solutionNo lung pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sampling bloodblood will be drawn from patients on day 1 and once a week until discharge/withdrawal/death | Diagnostic test | COVID-19 ARDS, No lung pathology, Non-pulmonary origin ARDS, Pneumonia-induced ARDS, Severe pneumonia but no ARDS |
| Lavage with physiologic saline solutionAlso: Mini-BALFmini-BALF using a physiologic saline soluation will be performed on day 1 and once a week until discharge/withdrawal/death | Diagnostic test | COVID-19 ARDS, No lung pathology, Non-pulmonary origin ARDS, Pneumonia-induced ARDS, Severe pneumonia but no ARDS |
Primary outcome
ARDS phenotypes
Time frame: 4 years
The application of multi-omics cluster analysis to reveal any distinct ARDS phenotypes or subgroup-specific characteristics.
3 secondary outcomes
Lung Microbiome Composition Analysis via 16S rRNA Gene Sequencing of Bronchoalveolar Lavage (BAL) Fluid
Time frame: 4 years
Metabolomic Profile of Bronchoalveolar Lavage Fluid and Plasma
Time frame: 4 years
Inflammatory Cytokine Profile in Bronchoalveolar Lavage Fluid and Plasma
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver Robak, Prof. PD Dr. study director
Medical University of Vienna, Department of Medicine 1
Riem Gawish, PhD principal investigator
Medical University of Vienna, Department of Medicine 1
1 site in 1 country: see every site and its status.
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.