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

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06272942
• Other study ID #: 22722
• Status: Active, not recruiting
• Start date: January 31, 2024
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140000
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Post Intensive Care Syndrome (PICS)
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Bayer	Whippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory, descriptive difference in ranking of PICS domain comorbidity ratios observed for ARDS (ICU admissions) versus pneumonia (non ICU admissions).	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.	At 1, 3, 6 and 12 months post-index admission
Primary	Morbidity	Morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.	at 1,3,6 and 12 month pre- and post- index hospital admission
Primary	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
Primary	Incident morbidity	Incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.	at 1, 3, 6 and 12 months post- index hospital admission
Primary	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
Primary	Difference in prevalence rates pre versus post index hospitalization		at 1, 3, 6 and 12 months post- index hospital admission
Primary	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

External Links

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