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
Qualifiers
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
Treatments tested in this trial
- ARTICE
Treatment groups
142 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov