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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 640,058 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
OTHER	An 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.

Timeline

• Start date: 2024-01-31
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-02-22
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States