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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 (SeeMe Tool)

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Bayer

Status

Active, not recruiting

Conditions

Post Intensive Care Syndrome (PICS)
Acute Respiratory Distress Syndrome (ARDS)

Treatments

Other: An ICU admission and a temporally related ARDS diagnosis

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

140,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

140,000 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Bayer Clinical Trials Contact

Data sourced from clinicaltrials.gov

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