do_not_disturb_altRecruitment Complete
Acute respiratory distress syndrome (ARDS), Post intensive care syndrome (PICS),
Bayer Identifier:
22722
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
140000Trial Dates
January 2024 - August 2025Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
| Status | Institution | Location |
|---|---|---|
Active, not recruiting | Bayer | Whippany, 07981, United States |
Primary Outcome
- MorbidityMorbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.date_rangeTime Frame:at 1,3,6 and 12 month pre- and post- index hospital admission
- Post ICU Syndrome-related morbidityPICS-related morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization. PICS stands for post intensive care unit syndrome.date_rangeTime Frame:at 12 months post- index hospital admission
- Incident morbidityIncident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.date_rangeTime Frame:at 1, 3, 6 and 12 months post- index hospital admission
- Post ICU Syndrome-related incident morbidityPICS-related incident morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.date_rangeTime Frame:at 1, 3, 6 and 12 months post- index hospital admission
- Difference in prevalence rates pre versus post index hospitalizationdate_rangeTime 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 admissionAverage total healthcare costs will be based on healthcare billing data in the one year post index ICU admission.date_rangeTime Frame:at 12 months post- index hospital admission
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
Health Services ResearchAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A