Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up

NCT06143137 · tracked via the Priya Life Science Germany tracker

Sponsor

Artcline GmbH

Phase

Observational

Started

2024-01-01

Last updated

2024-08-02

Condition(s) studied

Severe Sepsis

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Long term outcome after severe sepsis — 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

Trial sites (2)

Facility	City	Region	Status
Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin	Magdeburg	Germany	Recruiting
Universitätsmedizin Rostock, Abteilung KAI	Rostock	Germany	Recruiting

More Artcline GmbH trials in Germany

ARTICE® Real Data Collection & Observational Trial, Phase 4 Study Recruiting

Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06143137 on ClinicalTrials.gov ↗ ← All trials in Germany