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临床试验/NCT04567433
NCT04567433已完成不适用

Days Alive and Out of Hospital for Patients With Sepsis

The George Institute for Global Health, Australia1 个研究点 分布在 1 个国家目标入组 6,213 人开始时间: 2020年9月14日最近更新:
适应症
干预措施
相关药物

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

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

发起方
The George Institute for Global Health, Australia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anthony Delaney

Professorial Fellow

The George Institute for Global Health, Australia

研究点 (1)

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