Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Severe Sepsis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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:
1. General long term clinical and socio-economic outcome of sepsis survivors 2. Long-term outcome details of the ReActIF-ICE patient population 3. The potential long-term medical outcome effects of the additional ARTICE treatment compared to standard treatment alone. 4. The potential long-term health-related quality-of-life effects of ReActIF-ICE patient population 5. 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.
Primary outcome measures
- Long term outcome after severe sepsis [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 2 centers
- Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin — Magdeburg
- Universitätsmedizin Rostock, Abteilung KAI — Rostock
Identifiers
NCT: NCT06143137 · ReActIF-ICE-LTO_ZKSJ0154