Long-term follow-up of sepsis patients after immune cell therapy
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up
This study follows patients who received a special immune cell treatment for severe sepsis to see how they are doing in the long run and if it helps them feel better compared to standard care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 142 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Artcline GmbH Industry-sponsored |
| Locations | 2 sites (Magdeburg and 1 other locations) |
| Trial ID | NCT06143137 on ClinicalTrials.gov |
What this trial studies
This observational study follows patients who were previously enrolled in the ReActIF-ICE study, which investigated the effects of immune cell extracorporeal therapy in addition to standard treatment for severe sepsis. Participants will be monitored for up to five years to gather long-term data on their clinical outcomes, socio-economic impacts, and health-related quality of life. The study aims to provide insights into the lasting effects of sepsis and the potential benefits of the ARTICE treatment compared to standard care alone.
Who should consider this trial
Good fit: Ideal candidates are individuals who were enrolled in the ReActIF-ICE study and consented to long-term follow-up.
Not a fit: Patients who were not part of the ReActIF-ICE study or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of long-term recovery and quality of life for sepsis survivors.
How similar studies have performed: While this study builds on previous findings from the ReActIF-ICE study, long-term follow-up studies in sepsis have shown varying degrees of success in understanding patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Subject was enrolled in the ReActIF-ICE study and successfully passed the Day 2 re-evaluation of that trial. Exclusion Criteria: * none
Where this trial is running
Magdeburg and 1 other locations
- Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin — Magdeburg, Germany (Recruiting)
- Universitätsmedizin Rostock, Abteilung KAI — Rostock, Germany (Recruiting)
Study contacts
- Study coordinator: Erdmann J Zippel, RN
- Email: erdmann.zippel@artcline.de
- Phone: +4915772371146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.