Long-term follow-up of sepsis patients after immune cell therapy
Official title: Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up
Run by Artcline GmbH · NCT06143137 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 142 (estimated) |
| Sponsor | Artcline GmbH Industry-sponsored |
| Locations | 2 sites (Magdeburg and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | December 31, 2029 |
| Study ends | February 28, 2030 |
| Registry record updated | August 2, 2024 |
| Trial ID | NCT06143137 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who were enrolled in the ReActIF-ICE study and consented to long-term follow-up.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Plasma exchange for severely ill kids with sepsis
This trial tests whether adding therapeutic plasma exchange to standard sepsis care helps critically ill children with severe sepsis or septic shock.
-
A network to study severe infections in children in China
This study looks at how common severe infections like pneumonia and sepsis are in children in China to see how they can be better diagnosed and treated.
-
Investigating how transposable elements affect immune aging in sepsis patients
This study looks at how certain genetic elements might affect the immune system and health outcomes in people with sepsis in the ICU.
-
Identifying biomarkers for diagnosing sepsis in the emergency room
This study is trying to find out if certain immune responses can help doctors spot sepsis in patients with infections when they arrive at the emergency room.
-
Reducing unnecessary vancomycin use in children with suspected sepsis
This study is testing a new approach to see if better guidelines and education can help doctors use less vancomycin in children suspected of having sepsis, which could lower the risk of kidney problems.
-
Early use of norepinephrine for treating severe sepsis
This study is testing if giving norepinephrine earlier can help people with severe sepsis feel better and live longer compared to a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.