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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
NCT06272942 · View on ClinicalTrials.gov ↗
Study 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. 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.
Conditions Studied
Interventions
- OTHER An ICU admission and a temporally related ARDS diagnosis
Study Locations (1)
New Jersey
- Bayer — Whippany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140,000 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2025-08-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06272942
The ClinicalTrials.gov registry entry for NCT06272942 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Acute Respiratory Distress Syndrome (ARDS) appearing as the primary indexed condition, and to 1 intervention — of which An ICU admission and a temporally related ARDS diagnosis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06272942 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06272942 about?
NCT06272942 is a clinical study titled "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". 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 s...
What is the current status of trial NCT06272942?
This trial is currently active not recruiting. The enrollment target is 140,000 participants. The study started on 2024-01-31. Estimated completion is 2025-08-30.
What conditions does trial NCT06272942 study?
This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome (ARDS), Post Intensive Care Syndrome (PICS). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06272942?
The interventions under investigation include: An ICU admission and a temporally related ARDS diagnosis (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06272942?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06272942 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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