Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy
ConditionSepsis, Severe
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtcline GmbH
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
ARTICE
Biological/VaccineExtracorporal treatment with purified granulocyte concentrate
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: ARTICE Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From re-evaluation on Day 2 through Day 28Secondary outcomes
1
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
Time frame
From re-evaluation on Day 2 through Day 282
All cause mortality through Day 90
The difference in all-cause mortality from re-evaluation on Day 2 through Day 90 will be measured by time to event and Relative risk as well as Kaplan-Meier estimates with 95%-CI will be calculated through day 90
Time frame
From re-evaluation on Day 2 through Day 903
All-cause in-hospital mortality
The difference in all-cause mortality from re-evaluation on Day 2 through hospital discharge will be measured by time to event and Relative risk as well as Kaplan-Meier estimates with 95%-CI will be calculated through hospital discharge.
Time frame
From re-evaluation on Day 2 through until hospital discharge4
Daily changes in total SOFA and SOFA sub-scores
The SOFA (Sequential organ failure assessment score) Score URL"Sequential Organ Failure Assessment (SOFA) Score - MDCalc" is measured by addition of 6 Subscores for each of the 6 Organs between 1 and 4 \[n\]. The Change from Baseline (COBL) inbetween groups will be compared daily until day 10. Total score ranges from 0 (best) to 24 (worst); Subscores range from 0 (best) to 4 (worst)
Time frame
Until Day 10Sponsors and contacts
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Source ClinicalTrials.gov