Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Long term outcome after severe sepsis
研究概览
简要总结
Subjects previously enrolled / randomized in the ReActIF-ICE (Recovery from acute immune failure in septic shock by immune cell extracorporeal terapy - immune competence enhancement) study received either standard sepsis treatment (control group) or standard sepsis treatment and additionally the ARTICE treatment (treatment group) during their index hospitalization. All subjects are followed up for 90 days after enrollment.
In this long term follow up study, the enrolled subjects shall be followed up beyond 90 days for up to 5 years.
详细描述
Sepsis is a worldwide health threat because of high mortality and the development of long-lasting disabilities, including physical and cognitive impairment and mental disorders, known collectively as post-intensive care syndrome (PICS), which contribute to reduced health-related quality of life (HRQoL) for several years even after successful recovery from the initial acute sepsis state. Sepsis survivors often need a longer period of rehabilitation, consuming more medical and social resources and struggle with financial burdens.
In the ReActIF-ICE study, that started enrolling patients in July 2022, up to 142 subjects with severe sepsis are to be enrolled and randomized into a therapy group (receiving the ARTICE treatment (extracorporeal immune cell plasma perfusion) on top of standard care) and control group (standard care only). These subjects were followed up according the ReActIF-ICE study protocol for 90 days.
Since there is still a large need for long-term outcome data of sepsis patients, collecting data of the ReActIF-ICE patients over a longer period of time would provide important additional information regarding:
- General long term clinical and socio-economic outcome of sepsis survivors
- Long-term outcome details of the ReActIF-ICE patient population
- The potential long-term medical outcome effects of the additional ARTICE treatment compared to standard treatment alone.
- The potential long-term health-related quality-of-life effects of ReActIF-ICE patient population
- The potential long-term health-related quality-of-life effects of the additional ARTICE treatment compared to standard treatment alone.
In this long term follow up study, the enrolled subjects shall be followed up beyond 90 days for up to 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements or the implementation of other established procedures according to the local regulations of the contributing center to include subjects who are unable to provide informed consent.
- •Subject was enrolled in the ReActIF-ICE study and successfully passed the Day 2 re-evaluation of that trial.
排除标准
- 未提供
结局指标
主要结局
Long term outcome after severe sepsis
时间窗: 5 years
Outcome evaluation parameters * Survival rates at 6 months,1,2,3,4,5 years * Serious Adverse Events rate during the 5 year follow up period
次要结局
未报告次要终点