Severe SepsisReActIF- LTONCT06143137
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up
An observational study of Severe Sepsis, run by Artcline GmbH at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Sepsis
- How many people
- 142 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jan 2024to 28 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Klinikum Magdeburg, Klinik für Intensiv- und Rettungsmedizin
Magdeburg, 39130
Martin Sauer, Pof. Dr., +49391791 ext. 3105, martin.sauer@klinikum-magdeburg.de
Brigitte Specht, RN, +49391791 ext. 7839, brigitte.specht@klinikum-magdeburg.de
- Recruiting
Universitätsmedizin Rostock, Abteilung KAI
Rostock
Daniel Reuter, Prof. Dr., +49381-494 ext. 6401, Daniel.Reuter@med.uni-rostock.de
Heike Lösecke, RN, +49381494 ext. 146447, Heike.Loesecke@med.uni-rostock.de
About this study
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.
Read the 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:
- General long term clinical and socio-economic outcome of sepsis survivors
- Long-term outcome details of the ReActIF-ICE patient population
- The potential long-term medical outcome effects of the additional ARTICE treatment compared to standard treatment alone.
- The potential long-term health-related quality-of-life effects of ReActIF-ICE patient population
- 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.
- Conditions
- Severe Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artcline GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ZKS Jena
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143137
- Sponsor's protocol ID
- ReActIF-ICE-LTO_ZKSJ0154
- Acronym
- ReActIF- LTO
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up
- ClinicalTrials.gov ID
- NCT06143137
- Acronym / sponsor ID
- ReActIF- LTO / ReActIF-ICE-LTO_ZKSJ0154
- Conditions
- Severe Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Artcline GmbHIndustry (pharma, biotech, devices)
- Collaborators
- ZKS Jena
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- General long term clinical and socio-economic outcome of sepsis survivors
- Long-term outcome details of the ReActIF-ICE patient population
- The potential long-term medical outcome effects of the additional ARTICE treatment compared to standard treatment alone.
- The potential long-term health-related quality-of-life effects of ReActIF-ICE patient population
- 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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long term outcome after severe sepsis
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Severe Sepsis
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis, run by Artcline GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erdmann J Zippel, RN (+4915772371146, erdmann.zippel@artcline.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term outcome after severe sepsis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.