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

Sponsor
Artcline GmbH (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06143137
Collaborator
ZKS Jena (Other)
142
Enrollment
2
Locations
75.3
Anticipated Duration (Months)
71
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Sepsis is a worldwide health threat because of high mortality and the development of long-lasting disabilities, including physical and cognitive impairment and mental disorders, known collectively as post-intensive care syndrome (PICS), which contribute to reduced health-related quality of life (HRQoL) for several years even after successful recovery from the initial acute sepsis state. Sepsis survivors often need a longer period of rehabilitation, consuming more medical and social resources and struggle with financial burdens.

    In the ReActIF-ICE study, that started enrolling patients in July 2022, up to 142 subjects with severe sepsis are to be enrolled and randomized into a therapy group (receiving the ARTICE treatment (extracorporeal immune cell plasma perfusion) on top of standard care) and control group (standard care only). These subjects were followed up according the ReActIF-ICE study protocol for 90 days.

    Since there is still a large need for long-term outcome data of sepsis patients, collecting data of the ReActIF-ICE patients over a longer period of time would provide important additional information regarding:

    1. General long term clinical and socio-economic outcome of sepsis survivors

    2. Long-term outcome details of the ReActIF-ICE patient population

    3. The potential long-term medical outcome effects of the additional ARTICE treatment compared to standard treatment alone.

    4. The potential long-term health-related quality-of-life effects of ReActIF-ICE patient population

    5. The potential long-term health-related quality-of-life effects of the additional ARTICE treatment compared to standard treatment alone.

    In this long term follow up study, the enrolled subjects shall be followed up beyond 90 days for up to 5 years.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    142 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up
    Anticipated Study Start Date :
    Nov 20, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2029
    Anticipated Study Completion Date :
    Feb 28, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin Magdeburg Germany 39130
    2 Universitätsmedizin Rostock, Abteilung KAI Rostock Germany

    Sponsors and Collaborators

    • Artcline GmbH
    • ZKS Jena

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Artcline GmbH
    ClinicalTrials.gov Identifier:
    NCT06143137
    Other Study ID Numbers:
    • ReActIF-ICE-LTO_ZKSJ0154
    First Posted:
    Nov 22, 2023
    Last Update Posted:
    Nov 22, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sepsis

    Study Results

    No Results Posted as of Nov 22, 2023