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 | Completed

• 1 other identifier: 22722
• Study Type: observational
• Target: 640,058
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Morbidity

  Morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.

  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.

  at 12 months post- index hospital admission

• Incident morbidity

  Incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.

  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.

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

• Difference in prevalence rates pre versus post index hospitalization

  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.

  at 12 months post- index hospital admission

Other Outcomes (1)

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

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

Study Arms (1)

Post intensive care unit (ICU) morbidity

All adult patients in Optum Claims data from January 1, 2016 until October 1, 2022.

Other: An ICU admission and a temporally related ARDS diagnosis

Interventions

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.

Post intensive care unit (ICU) morbidity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Whippany, New Jersey, 07981, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; postintensive care syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: January 31, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)