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NCT Number: NCT06272942

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 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.

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Key information

Conditions

Acute Respiratory Distress Syndrome (ARDS) Lung Diseases Post Intensive Care Syndrome (PICS) Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayer

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

An ICU admission and a temporally related ARDS diagnosis

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Difference in prevalence rates pre versus post index hospitalization

    Time frame: at 1, 3, 6 and 12 months post- index hospital admission

  6. 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.

Other outcomes

  1. Exploratory, descriptive difference in ranking of PICS domain comorbidity ratios observed for ARDS (ICU admissions) versus pneumonia (non ICU admissions).

    Time frame: At 1, 3, 6 and 12 months post-index admission

    Descriptive analyses will be performed and trajectories of post ARDS (ICU admission) versus pneumonia (non ICU admission) will be compared visually using waterfall plots.

    ARDS stands for acute respiratory distress syndrome.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: SeeMe Tool

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2024
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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