[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Artcline GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100622823","artice-real-data-collection--observational-trial-phase-4-study-100622823",false,"NCT07388628","ARTICE® Real Data Collection & Observational Trial, Phase 4 Study","ARTISTRY - ARTICE® Therapy Registry Study","ARTistry","Inclusion Criteria:\n\n* Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","7 Days","OBSERVATIONAL","The objectives of this registry study are to:\n\n1. Record real-life data related to the use of the ARTICE® therapy in sepsis subjects.\n2. Further evaluate ARTICE® treatment efficacy.\n3. Identify potential sub-groups, assess their risk-benefit- and safety profile.\n4. Changes in SOFA score D0 to SOFA Score D7.",[26,27,28],"Sepsis","Septic Shock","Immunoparalysis in Septic Shock",[26,30,28],"septic shock","RECRUITING","2026-02-06",{"date":34,"type":35},"2026-02-09","ACTUAL",{"date":37,"type":35},"2025-09-25",{"date":39,"type":21},"2027-12",{"name":41,"class":42},"Artcline GmbH","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100473270","phase-2-recovery-from-acute-immune-failure-in-septic-shock-by-immune-cell-extracorporeal-therapy-100473270","NCT05442710","Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy","ReActiF-ICE","Inclusion Criteria:\n\n1. Adult subjects\n\n   1. ≥ 18 years of age\n   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\u002Fkg\u002Fmin (and\u002For vasopressin at any dose) for a minimum of 6 hours (within the last 48 hours), to maintain a MAP ≥65 mmHg\n   3. Subjects ≥ 80 years of age shall have a Clinical Frailty Scale of \\\u003C5 to be enrolled.\n2. 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.\n3. Blood lactate \\>2 mmol\u002FL despite adequate volume resuscitation during the current sepsis episode\n4. Source control achieved \u002F in progress in the judgement of the investigator\n5. 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.\n6. Subjects must have received adequate volume replacement in the judgement of the investigator.\n7. 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.\n\nExclusion Criteria:\n\n1. Acute or chronic leukemia,\n2. Bilirubin ≥ 2 mg\u002FdL (≥33 µmol\u002FL),\n3. Ongoing (concomitant) or prior within the last 6 month any chemotherapy or radiotherapy for malignancy,\n4. Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent,\n5. Previous transplantation,\n6. Subjects receiving interferon therapy (14 days prior randomisation),\n7. Acute pulmonary embolism within the last 72 hours,\n8. Ischemic stroke or intracranial bleeding within the last 3 months\n9. Suspicion of concomitant acute coronary syndrome based on clinical symptoms and\u002For ECG within the last 72 hours,\n10. Cardiopulmonary resuscitation within last 7 days,\n11. Moribund subject (life expectancy \\\u003C72 hours), in the judgement of the investigator\n12. Presence of a do-not-resuscitate or do-not-intubate order,\n13. Known HIV infection or chronic viral hepatitis,\n14. Isolated Urosepsis,\n15. Pregnancy\u002Fnursing period,\n16. Primary cause of hypotension not due to sepsis (e.g. major trauma including traumatic brain injury, haemorrhage, burns, or congestive heart failure\u002Fcardiogenic shock),\n17. Previous sepsis with ICU admission within this hospital stay,\n18. Known\u002Fsuspected acute mesenteric ischaemia,\n19. 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,\n20. Decision to limit full care taken before obtaining informed consent,\n21. Prior enrolment in the trial,\n22. 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,\n23. multiple injuries including polytrauma and burn \\>20% TBSA (2° or 3°),\n24. Diagnosed and documented pre-existing dementia,\n25. Severe Covid-Pneumonia",{"count":52,"type":21},142,"INTERVENTIONAL",[55],"PHASE2","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.\n\nThis may contribute to the improvement of the impaired organ function of septic shock patients by assisting the impaired immune system (immune competence enhancement = ARTICE)",[58],"Sepsis, Severe","2025-05-21",{"date":61,"type":35},"2025-05-25",{"date":63,"type":35},"2022-07-24",{"date":65,"type":21},"2026-06-30",{"name":41,"class":42},20,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100527082","recovery-from-acute-immune-failure-in-septic-shock-by-immune-cell-extracorporeal-therapy---observational-long-term-outcome-follow-up-100527082","NCT06143137","Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outcome Follow up","ReActIF- LTO","Inclusion Criteria:\n\n1. 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.\n2. Subject was enrolled in the ReActIF-ICE study and successfully passed the Day 2 re-evaluation of that trial.\n\nExclusion Criteria:\n\n* none","80 Years",{"count":52,"type":21},"Subjects previously enrolled \u002F 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.\n\nIn this long term follow up study, the enrolled subjects shall be followed up beyond 90 days for up to 5 years.",[79],"Severe Sepsis","2024-08-01",{"date":82,"type":35},"2024-08-02",{"date":84,"type":35},"2024-01-01",{"date":86,"type":21},"2030-02-28",{"name":41,"class":42},2,""]