临床试验/NCT05442710

NCT05442710招募中2 期

Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy

Artcline GmbH20 个研究点分布在 1 个国家目标入组 142 人开始时间: 2022年7月24日最近更新: 2025年5月25日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: Artcline GmbH
入组人数: 142
试验地点: 20
主要终点: Safety and tolerability of the ARTICE therapy, composed of new onset of serious adverse events from re-evaluation on Day 2 through Day 28

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

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)

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adult subjects
•≥ 18 years of age
•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
•Subjects ≥ 80 years of age shall have a Clinical Frailty Scale of <5 to be enrolled.
•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.
•Blood lactate >2 mmol/L despite adequate volume resuscitation during the current sepsis episode
•Source control achieved / in progress in the judgement of the investigator
•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.
•Subjects must have received adequate volume replacement in the judgement of the investigator.
•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.

排除标准

•Acute or chronic leukemia,
•Bilirubin ≥ 2 mg/dL (≥33 µmol/L),
•Ongoing (concomitant) or prior within the last 6 month any chemotherapy or radiotherapy for malignancy,
•Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent,
•Previous transplantation,
•Subjects receiving interferon therapy (14 days prior randomisation),
•Acute pulmonary embolism within the last 72 hours,
•Ischemic stroke or intracranial bleeding within the last 3 months
•Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG within the last 72 hours,
•Cardiopulmonary resuscitation within last 7 days,
•Moribund subject (life expectancy <72 hours), in the judgement of the investigator
•Presence of a do-not-resuscitate or do-not-intubate order,
•Known HIV infection or chronic viral hepatitis,
•Isolated Urosepsis,
•Pregnancy/nursing period,
•Primary cause of hypotension not due to sepsis (e.g. major trauma including traumatic brain injury, haemorrhage, burns, or congestive heart failure/cardiogenic shock),
•Previous sepsis with ICU admission within this hospital stay,
•Known/suspected acute mesenteric ischaemia,
•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,
•Decision to limit full care taken before obtaining informed consent,
•Prior enrolment in the trial,
•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,
•multiple injuries including polytrauma and burn >20% TBSA (2° or 3°),
•Diagnosed and documented pre-existing dementia,
•Severe Covid-Pneumonia

研究组 & 干预措施

ARTICE Treatment Group

Experimental

Subjects with septic shock treated with immune cell extracorporeal therapy on top of standard of care

干预措施: ARTICE (Biological)

结局指标

主要结局

Safety and tolerability of the ARTICE therapy, composed of new onset of serious adverse events from re-evaluation on Day 2 through Day 28

时间窗: From re-evaluation on Day 2 through Day 28

The number \[n\] of new onsets of serious adverse events (SAEs) from re-evaluation-Day 2 through Day 28 will be counted in both arms and the difference between groups will be compared.

次要结局

Number of renal-replacement-free days(From re-evaluation on Day 2 until Day 28)
All cause mortality through Day 28(From re-evaluation on Day 2 through Day 28)
Number of mechanical-ventilator-free days(From re-evaluation on Day 2 until Day 28)
Antibiotic exposure days until hospital discharge(From re-evaluation on Day 2 until Day 28)
Time to complete organ failure resolution(From re-evaluation on Day 2 until Day 28 with special focus on D14 an D21)
ICU length of stay Measured / Confirmed on day 28 retrospectively. Units: Days(Until Day 28)
Number of vasopressor- free days(From re-evaluation on Day 2 until Day 28)
Frequency of secondary infections(From re-evaluation on Day 2 until Day 28)
Time course of key inflammatory/ immunological markers in between the two groups.(From re-evaluation on Day 2 until Day 28)
Number of ICU-free days Measured / Confirmed on day 28 retrospectively. Units: Days(Until day 28)
Number of days without antimicrobial therapy(From re-evaluation on Day 2 until Day 28)
Total daily dose of noradrenalin (NA) administered on each day(From re-evaluation on Day 2 until Day 10)
Maximum daily dose of noradrenalin administration on treatment days(From re-evaluation on Day 2 until Day 10)
Occurrence of virus induced inflammation episodes(From re-evaluation on Day 2 until Day 28)
All cause mortality through Day 90(From re-evaluation on Day 2 through Day 90)
All-cause in-hospital mortality(From re-evaluation on Day 2 through until hospital discharge)
Daily changes in total SOFA and SOFA sub-scores(Until Day 10)
Number of hospital-free days. Measured / Confirmed on day 28 retrospectively. Units: Days(Until Day 28)
Occurrence of cognitive decline(Until day 90)
Days [n] alive without antibiotics until hospital discharge(From re-evaluation on Day 2 until Day 28)
Time course of key biomarkers of neuroaxonal injury(Until day 28)
Inflammatory mRNA profiling analysis(until day 10)
Quality of life assessment(Until day 90)

研究者

发起方

Artcline GmbH

申办方类型

Industry

责任方

Sponsor

研究点 (20)

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