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Clinical Trials/NCT06272942
NCT06272942
Active, not recruiting
Not Applicable

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

Bayer1 site in 1 country140,000 target enrollmentJanuary 31, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome (ARDS)
Sponsor
Bayer
Enrollment
140000
Locations
1
Primary Endpoint
Difference in prevalence rates pre versus post index hospitalization
Status
Active, not recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2024
End Date
August 30, 2025
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bayer
Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Difference in prevalence rates pre versus post index hospitalization

Time Frame: 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

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.

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.

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.

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.

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.

Study Sites (1)

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