Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210,484
- 主要终点
- Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis
研究概览
简要总结
The study aims to map the health-related quality of life (HRQoL) after intensive care for Sepsis with the hypothesis that it will be lower than that in the general population. The investigators also want to identify factors that are associated with low HRQoL, to see if those are available for interventions from the health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (ICU).
详细描述
Background Sepsis is a common condition in intensive care units leading to severe illness with a high mortality. It can also lead to significant disability for the individuals after recovery.
Objective The investigators aim to study how intensive care for/with sepsis impacts the HRQoL and, if possible, identify improvable factors in the treatment and rehabilitation.
Method This is a cohort study on all ICU patients with sepsis registered in the Swedish Intensive Care registry (SIR) as well as age and gender matched population controls. The primary outcome variable HRQoL will be assessed by RAND-36. The investigators assess functional recovery by sick leave free days. SIR provides post-ICU follow-up data on RAND-36. The investigators will merge these data with data on comorbidity from the National patient register, causes of death from the National death registry, socioeconomic factors from Statistics Sweden, as well as the data on social benefits from the Swedish Social Insurance Agency.
The main analysis compares RAND-36 from sepsis patients with population controls over time. The investigators will also compare the complete sepsis cohort's burden of inability to work before and sick leave free days after sepsis with matched population controls. Additionally, the investigators will describe the complete sepsis cohort's burden of disease measured with Charlson Comorbidity Index against matched population controls.
Ethics The study has ethical permission from Swedish Ethical Review Authority, nos 2022-00445-01 and 2022-07264-02.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to an ICU in Sweden that reports to the Swedish ICU register
- •Admitted between January 1st 2008 until February 28th 2020
- •Admitted for sepsis or septic shock and / or
- •Received sepsis or septic shock diagnosis during ICU stay
排除标准
- •Age under 18
结局指标
主要结局
Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis
时间窗: Data dependent but up untill about 15 moth anticipated
Health-related Quality of Life (HRQoL), measured with the RAND-36 test over time after ICU treatment with/for sepsis compared with population controls. The RAND-36 is a test that assess Health-Related Quality of Life were higher scores are associated with higher HRQoL.
次要结局
- Ability to work before and after ICU (intensive care unit) treatment for Sepsis(1 year prior ICU admittance and 2 years after ICU admittance)
- The burden of disease at ICU (intensive care unit) admittance and after ICU treatment for Sepsis(From ICU admittance and 2 years after ICU admittance)
研究者
Miklos Lipcsey
Professor
Uppsala University Hospital