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
NCT ID: NCT06272942
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
140000 participants
OBSERVATIONAL
2024-01-31
2025-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying ARDS Endotypes
NCT05451342
Severe Hypoxemia : Prevalence, Treatment and Outcome
NCT02722031
Impact of Arterial CO2 Tension on Management and Outcome in Patients With Acute Hypoxemic Respirator Failure and ARDS
NCT03415529
Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE
NCT02010073
EVLWI Exhibits Pulmonary and Systemic Permeability in Sepsis Related ALI/ARDS
NCT01694147
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Post intensive care unit (ICU) morbidity
All adult patients in Optum Claims data from January 1, 2016 until October 1, 2022.
An ICU admission and a temporally related ARDS diagnosis
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
An ICU admission and a temporally related ARDS diagnosis
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age \>= 18 years
* not seen outside the healthcare system
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bayer
Whippany, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for access to information about Bayer's transparency standards and Bayer studies.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22722
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.