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临床试验/NCT06272942
NCT06272942进行中(未招募)不适用

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

Bayer1 个研究点 分布在 1 个国家目标入组 140,000 人开始时间: 2024年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Bayer
入组人数
140,000
试验地点
1
主要终点
Difference in prevalence rates pre versus post index hospitalization

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • continuous coverage of at least 365 days (>= 1 year) pre-index date for the cohort
  • age >= 18 years
  • not seen outside the healthcare system

排除标准

  • 未提供

结局指标

主要结局

Difference in prevalence rates pre versus post index hospitalization

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: at 1,3,6 and 12 month pre- and post- index hospital admission

Morbidity will be stratified by comorbidities, procedures, medications, healthcare utilization.

次要结局

未报告次要终点

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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