Recovery From Acute Immune Failure in Septic Shock by Imm... | NCT05442710

Status Module

Name	Class
Zentrum für Klinische Studien Jena	OTHER
RQM+	INDUSTRY

Label	Type	Description	Intervention Names
ARTICE Treatment Group	Experimental	Subjects with septic shock treated with immune cell extracorporeal therapy on top of standard of care	Biological: ARTICE
Control Group	No Intervention	Subjects with septic shock receiving standard of care

Name	Type	Description	Arm Group Labels	Other Names
ARTICE	Biological	Extracorporal treatment with purified granulocyte concentrate	ARTICE Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of the ARTICE therapy, composed of new onset of serious adverse events 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.	From re-evaluation on Day 2 through Day 28

Secondary Outcomes

Measure	Description	Time Frame
All cause mortality through Day 28	The difference in all-cause mortality from re-evaluation on Day 2 through Day 28 will be measured by time to event and Relative risk as well as Kaplan-Meier estimates with 95%-CI will be calculated through day 28	From re-evaluation on Day 2 through Day 28
All cause mortality through Day 90

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
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.

Exclusion Criteria:

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

Name	Role	Phone	Extension	Email
Jens Altrichter, MD	Contact	+49 381-440-703	0	jens.altrichter@artcline.de
Erdmann J Zippel, RN	Contact	*4915772371146		erdmann.zippel@artcline.de

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms