NCT05442710 Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy
| NCT ID | NCT05442710 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Artcline GmbH |
| Condition | Sepsis, Severe |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2022-07-24 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 142 participants in total. It began in 2022-07-24 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluation of a novel therapy approach for severe sepsis patients. Subjects randomized into the treatment arm receive treatment with an immune cell perfusion system on top of standard care. This may contribute to the improvement of the impaired organ function of septic shock patients by assisting the impaired immune system (immune competence enhancement = ARTICE)
Eligibility Criteria
Inclusion Criteria: 1. Adult subjects 1. ≥ 18 years of age 2. with septic shock, defined as those with septic shock according to" Sepsis-3-Definition" who additionally require norepinephrine at a dose of ≥ 0.15 mcg/kg/min (and/or vasopressin at any dose) for a minimum of 6 hours (within the last 48 hours), to maintain a MAP ≥65 mmHg 3. Subjects ≥ 80 years of age shall have a Clinical Frailty Scale of \<5 to be enrolled. 2. Fulfillment of the definition of septic shock, not longer than 48h before randomization. I.e. the 48h start at the end of the 6h period. 3. Blood lactate \>2 mmol/L despite adequate volume resuscitation during the current sepsis episode 4. Source control achieved / in progress in the judgement of the investigator 5. Subjects are required to have central venous access and an arterial line, and these are expected to remain present for at least the initial 48 hours of study. 6. Subjects must have received adequate volume replacement in the judgement of the investigator. 7. Subject or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements or confirmation of the urgency of participation in the clinical trial and the possible benefit to the subject by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing centre to include subjects who are unable to provide informed consent. Exclusion Criteria: 1. Acute or chronic leukemia, 2. Bilirubin ≥ 2 mg/dL (≥33 µmol/L), 3. Ongoing (concomitant) or prior within the last 6 month any chemotherapy or radiotherapy for malignancy, 4. Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent, 5. Previous transplantation, 6. Subjects receiving interferon therapy (14 days prior randomisation), 7. Acute pulmonary embolism within the last 72 hours, 8. Ischemic stroke or intracranial bleeding within the last 3 months 9. Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG within the last 72 hours, 10. Cardiopulmonary resuscitation within last 7 days, 11. Moribund subject (life expectancy \<72 hours), in the judgement of the investigator 12. Presence of a do-not-resuscitate or do-not-intubate order, 13. Known HIV infection or chronic viral hepatitis, 14. Isolated Urosepsis, 15. Pregnancy/nursing period, 16. Primary cause of hypotension not due to sepsis (e.g. major trauma including traumatic brain injury, haemorrhage, burns, or congestive heart failure/cardiogenic shock), 17. Previous sepsis with ICU admission within this hospital stay, 18. Known/suspected acute mesenteric ischaemia, 19. Chronic mechanical ventilation for any reason OR severe COPD requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days, 20. Decision to limit full care taken before obtaining informed consent, 21. Prior enrolment in the trial, 22. Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or device, 23. multiple injuries including polytrauma and burn \>20% TBSA (2° or 3°), 24. Diagnosed and documented pre-existing dementia, 25. Severe Covid-Pneumonia
Contact & Investigator
Daniel Reuter, Prof.Dr.
PRINCIPAL INVESTIGATOR
University Hospital Rostock
Frequently Asked Questions
Who can join the NCT05442710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis, Severe. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05442710 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05442710 currently recruiting?
Yes, NCT05442710 is actively recruiting participants. Contact the research team at jens.altrichter@artcline.de for enrollment information.
Where is the NCT05442710 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany, Regensburg, Germany, Bonn, Germany, Cologne, Germany and 11 additional locations.
Who is sponsoring the NCT05442710 clinical trial?
NCT05442710 is sponsored by Artcline GmbH. The principal investigator is Daniel Reuter, Prof.Dr. at University Hospital Rostock. The trial plans to enroll 142 participants.