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.
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.
none
All applicable subjects previously enrolled in the ReActIF-ICE study will be asked to participate in this long-term study, if they are fulfilling all inclusion criteria.
Other
Prospective
Not listed
Long term outcome after severe sepsis
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
Click on the lead sponsor to view all of their trials.
Artcline GmbH
Lead sponsor
ZKS Jena
Collaborator
