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

NCT06143137 | Recruiting

• 1 other identifier: ReActIF-ICE-LTO_ZKSJ0154
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Severe Sepsis

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Study Arms (2)

Control group

Subjects in this group where randomized in the control group in the ReActiF-ICE study previously

Therapy Group

Subjects in this group where randomized in the therapy group in the ReActiF-ICE study previously

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Artcline GmbH: lead
• ZKS Jena: collaborator

Study Sites (2)

Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin

Magdeburg, 39130, Germany

RECRUITING

Universitätsmedizin Rostock, Abteilung KAI

Rostock, Germany

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erdmann J Zippel, RN

CONTACT

+4915772371146; erdmann.zippel@artcline.de

Jens Altrichter, MD

CONTACT

+49 3814407030; jens.altrichter@artcline.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: November 22, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: August 2, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)