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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

Identifying Post ICU Morbidity in Patients With ARDS in the United States

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06272942
Acronym
SeeMe Tool
Enrollment
640058
Registered
2024-02-22
Start date
2024-01-31
Completion date
2026-03-31
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome (ARDS), Post Intensive Care Syndrome (PICS)

Brief 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.

Interventions

OTHERAn 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.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* continuous coverage of at least 365 days (\>= 1 year) pre-index date for the cohort * age \>= 18 years * not seen outside the healthcare system

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Morbidityat 1,3,6 and 12 month pre- and post- index hospital admissionMorbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Post ICU Syndrome-related morbidityat 12 months post- index hospital admissionPICS-related morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization. PICS stands for post intensive care unit syndrome.
Incident morbidityat 1, 3, 6 and 12 months post- index hospital admissionIncident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Post ICU Syndrome-related incident morbidityat 1, 3, 6 and 12 months post- index hospital admissionPICS-related incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Difference in prevalence rates pre versus post index hospitalizationat 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 admissionat 12 months post- index hospital admissionAverage total healthcare costs will be based on healthcare billing data in the one year post index ICU admission.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026