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

Active, not recruiting

• Conditions: Post Intensive Care Syndrome (PICS); Acute Respiratory Distress Syndrome (ARDS)
• Interventions: Other: An ICU admission and a temporally related ARDS diagnosis

• Registration Number: NCT06272942
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-31
• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post intensive care unit (ICU) morbidity	An ICU admission and a temporally related ARDS diagnosis	All adult patients in Optum Claims data from January 1, 2016 until October 1, 2022.

Primary Outcome Measures

Name	Time	Method
Morbidity	at 1,3,6 and 12 month pre- and post- index hospital admission	Morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
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	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.
Post ICU Syndrome-related morbidity	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.
Incident morbidity	at 1, 3, 6 and 12 months post- index hospital admission	Incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.
Post ICU Syndrome-related incident morbidity	at 1, 3, 6 and 12 months post- index hospital admission	PICS-related incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.

Trial Locations

Locations (1)

Bayer; 🇺🇸 Whippany, New Jersey, United States