Acute Respiratory Distress Syndrome (ARDS)SeeMe ToolNCT06272942
An Observational Study to Identify New Health Problems Arising After an Intensive Care Unit Admission in People With Acute Respiratory Distress Syndrome in the United States
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Post Intensive Care Syndrome (PICS), run by Bayer at 1 site in United States.
Trial summary
This is an observational study in which data already collected from people with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) are studied. ARDS is a life-threatening condition in which fluid builds up in the lungs making breathing difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Post Intensive Care Syndrome (PICS)
- What is being tested?
- An ICU admission and a temporally related ARDS diagnosis
- How many people
- 640,058 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients in Optum Claims data with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) from January 1, 2016 until October 1, 2022.
Who may be able to join
- continuous coverage of at least 365 days (>= 1 year) pre-index date for the cohort
- age >= 18 years
- not seen outside the healthcare system
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Post ICU Morbidity in Patients With ARDS in the United States
This is an observational study in which data already collected from people with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) are studied.
ARDS is a life-threatening condition in which fluid builds up in the lungs making breathing difficult.
Read more
In observational studies, only observations are made without participants receiving any advice or any changes to health care.
People who are admitted to ICU for serious illnesses, like ARDS, often experience new health problems during and after their ICU stays. These health problems that may include physical, mental, and/or emotional disorders, are called post-intensive care syndrome (PICS). Identifying these new health problems early can help people by timely treatments and care.
In this study, researchers want to identify any health problems that arise after ICU admission in people with ARDS in the United States (US). To do this, researchers will collect information on health problems, treatments, medicines, and healthcare visits in people with ARDS, 1 year before and after an ICU admission.
They will then look to see whether the health problems are in areas that have been described as the post intensive care syndrome (PICS).
In addition, they will measure healthcare related costs in the one year after admission and compare it to the one year prior to admission.
Researchers will also compare this information with data collected for people with pneumonia who did not require ICU admission. This will help them to identify any new health problems arising due to ICU stays.
The data will come from participants' medical claims information stored in the Optum Clinformatics Data Mart database from 2016 to 2022. The claims data will only be collected for people in the US.
Researchers will collect data from participants admitted to ICU for ARDS for a maximum of 1 year before and after their stay.
- Being tested
- An ICU admission and a temporally related ARDS diagnosis
- Medical subject headings
- Respiratory Distress Syndrome, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An ICU admission and a temporally related ARDS diagnosisOther
This is a disease study to learn more about the morbidity after an ICU admission and a temporally related ARDS diagnosis.
ARDS stands for acute respiratory distress syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Post intensive care unit (ICU) morbidity | All adult patients in Optum Claims data from January 1, 2016 until October 1, 2022. Receives: Other: An ICU admission and a temporally related ARDS diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Measured: at 1,3,6 and 12 month pre- and post- index hospital admission
Post ICU Syndrome-related morbidity
PICS-related morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
PICS stands for post intensive care unit syndrome.
Measured: at 12 months post- index hospital admission
Incident morbidity
Incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Measured: at 1, 3, 6 and 12 months post- index hospital admission
Post ICU Syndrome-related incident morbidity
PICS-related incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Measured: at 1, 3, 6 and 12 months post- index hospital admission
Difference in prevalence rates pre versus post index hospitalization
Measured: at 1, 3, 6 and 12 months post- index hospital admission
Average total healthcare costs based on healthcare billing data in the one year post index ICU admission
Average total healthcare costs will be based on healthcare billing data in the one year post index ICU admission.
Measured: at 12 months post- index hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start31 Jan 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by BayerThe 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
- Retrospective
- Enrolment
- 640,058 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272942
- Sponsor's protocol ID
- 22722
- Acronym
- SeeMe Tool
- Status last verified
- Mar 2026
- First submitted
- 15 Feb 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Post ICU Morbidity in Patients With ARDS in the United States
- ClinicalTrials.gov ID
- NCT06272942
- Acronym / sponsor ID
- SeeMe Tool / 22722
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 640,058 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 22 Feb 2024 (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.
This is an observational study in which data already collected from people with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) are studied.
ARDS is a life-threatening condition in which fluid builds up in the lungs making breathing difficult.
In observational studies, only observations are made without participants receiving any advice or any changes to health care.
People who are admitted to ICU for serious illnesses, like ARDS, often experience new health problems during and after their ICU stays. These health problems that may include physical, mental, and/or emotional disorders, are called post-intensive care syndrome (PICS). Identifying these new health problems early can help people by timely treatments and care.
In this study, researchers want to identify any health problems that arise after ICU admission in people with ARDS in the United States (US). To do this, researchers will collect information on health problems, treatments, medicines, and healthcare visits in people with ARDS, 1 year before and after an ICU admission.
They will then look to see whether the health problems are in areas that have been described as the post intensive care syndrome (PICS).
In addition, they will measure healthcare related costs in the one year after admission and compare it to the one year prior to admission.
Researchers will also compare this information with data collected for people with pneumonia who did not require ICU admission. This will help them to identify any new health problems arising due to ICU stays.
The data will come from participants' medical claims information stored in the Optum Clinformatics Data Mart database from 2016 to 2022. The claims data will only be collected for people in the US.
Researchers will collect data from participants admitted to ICU for ARDS for a maximum of 1 year before and after their stay.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post intensive care unit (ICU) morbidity | – | Other: An ICU admission and a temporally related ARDS diagnosisAll adult patients in Optum Claims data from January 1, 2016 until October 1, 2022. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients in Optum Claims data with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) from January 1, 2016 until October 1, 2022.
Key inclusion criteria (3 listed)
- continuous coverage of at least 365 days (>= 1 year) pre-index date for the cohort
- age >= 18 years
- not seen outside the healthcare system
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| An ICU admission and a temporally related ARDS diagnosisThis is a disease study to learn more about the morbidity after an ICU admission and a temporally related ARDS diagnosis. ARDS stands for acute respiratory distress syndrome. | Other | Post intensive care unit (ICU) morbidity |
Primary outcome
Morbidity
Time frame: at 1,3,6 and 12 month pre- and post- index hospital admission
Morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Post ICU Syndrome-related morbidity
Time frame: at 12 months post- index hospital admission
PICS-related morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization. PICS stands for post intensive care unit syndrome.
Incident morbidity
Time frame: at 1, 3, 6 and 12 months post- index hospital admission
Incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Post ICU Syndrome-related incident morbidity
Time frame: at 1, 3, 6 and 12 months post- index hospital admission
PICS-related incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Difference in prevalence rates pre versus post index hospitalization
Time frame: at 1, 3, 6 and 12 months post- index hospital admission
Average total healthcare costs based on healthcare billing data in the one year post index ICU admission
Time frame: at 12 months post- index hospital admission
Average total healthcare costs will be based on healthcare billing data in the one year post index ICU admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Respiratory Distress Syndrome (ARDS) and Post Intensive Care Syndrome (PICS), run by Bayer at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 2 Apr 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: at 1,3,6 and 12 month pre- and post- index hospital admission). The study lists 6 primary outcomes in all. 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 2 Apr 2026.