Days Alive and Out of Hospital for Patients With Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,213
- 试验地点
- 1
- 主要终点
- Quality of Life as measured by the EQ5D
研究概览
简要总结
We will perform a retrospective cohort study to assess the construct validity and performance of days alive and out of hospital at day 90 (DAOH90) in cohorts of patients with sepsis and septic shock who have been included in recent clinical trials.
详细描述
Study Design
We will conduct a retrospective cohort study. After obtaining all required ethics approvals, we will obtain data from the ARISE, CHEST, and ADRENAL studies. We will obtain from each dataset, for each trial participant with sepsis, data regarding; Demographic details, co-morbidities, pre-morbid living situation, baseline severity of illness, receipt of and duration of organ support during the index hospitalisation, Duration of ICU stay during index hospitalisation, ICU mortality, Hospital length of stay (LOS) and mortality for index hospitalisation, Discharge destination from index hospitalisation, readmissions to hospital up to 2 years, long term mortality, and quality of life as measured by the EQ5D at longest follow-up.
The primary objective of the study is to assess the association between Days Alive and Out of Hospital at day 90 and longer-term quality of life as measured by the EQ5D.
Secondary objectives include:
- To describe the characteristics of DAOH90 in patients with sepsis and septic shock with respect to the distribution and the pattern of variability
- To assess the construct validity of DAOH90, by testing the association between baseline variables and process of care variables and DAOH90, with the hypothesis that indicators for more "sickness" will be associated with fewer DAOH
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
- 否
入选标准
- •We will include data from all participants in the ARISE and ADRENAL trials where there is data available to calculate the number of days alive and out of hospital to Day 90, and data available with regards to quality of life at 6 months following recruitment.
- •We will include data from all participants in the CHEST trial who had a diagnosis of sepsis at baseline, and for whom there is data available to calculate the number of days alive and out of hospital to Day 90 and data available with regards to quality of life at 6 months following recruitment
排除标准
- 未提供
研究组 & 干预措施
CHEST Study
Participants in the CHEST trial long term sepsis cohort
干预措施: Hydroxyethyl starch (Drug)
ARISE Study
Participants in the ARISE study long term follow-up cohort
干预措施: Early Goal Directed Therapy (Procedure)
ADRENAL study
Participants in the ADRENAL study
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
Quality of Life as measured by the EQ5D
时间窗: 6 months
Quality of Life as measured by the EQ5D
次要结局
未报告次要终点
研究者
Anthony Delaney
Professorial Fellow
The George Institute for Global Health, Australia
