Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating cfDNA/NETs in Subjects With Sepsis

This is a prospective, multinational, multicentre, randomised, parallel-group, open-label study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of circulating cell-free DNA (cfDNA)/Neutrophil Extracellular Traps (NETs) in sepsis patients.

Inclusion Criteria:Adult patients aged 18-75Proven or suspected respiratory sepsis aetiologyAcute respiratory failure currently requiring invasive mechanical ventilation for not more than 48 hours durationHorowitz Index for Lung Function (Pa02/Fi02 Ratio) ≤200mmHg or ≤26.6kPaSequential organ failure assessment score (SOFA) ≥4 and ≤ 14Have provided written informed consent or consent is given by the patient's legally designated representative or an independent physician (if possible, according to local law).Exclusion Criteria:Expected duration of invasive mechanical ventilation less than 48 hoursThe use of other non-routine extracorporeal sepsis treatments such as very high flux renal replacement therapy (>60ml/kg/h total exchange), use of high cut off filters or other non-routine extracorporeal treatment columns such as Cytosorb, Toramyxcin, etc).Presence of severe multiple organ failure at the point of enrolment as evidenced by:Severe refractory vasoplegic failureNorepinephrine dose > 0.60 μg/kg/minUse of epinephrineConcomitant cardiogenic shock, clinically suspected or CI<2.2 if measuredUse of dobutamine, epinephrine, phosphodiesterase inhibitors or levosimendanCoagulopathy as defined by platelet count <50Calculated Plasma Volume greater than 5000ml as determined by an estimation of total blood volume (according to Nadler's formula, incorporating height, weight and sex) multiplied by (1- Haematocrit). A total blood volume calculator is available at https://www.omnicalculator.com/health/blood-volumeLong term oxygen therapy or home oxygen useLiver cirrhosis (histologically proven or clinically suspected)Active bleedingCitrate intolerance if citrate is required for therapeutic apheresisHeparin allergy if heparin is required for therapeutic apheresisMetastatic disease with life expectancy of <12 months and ECOG score of at least 2Haematological malignancy if not in remissionSolid organ transplant and concomitant use of immunosuppressionDialysis dependent Chronic Kidney Disease (CKD Stage 5-D)Prior use of cardiopulmonary resuscitation (CPR) in index admissionRequirement for extracorporeal membrane oxygenation (ECMO)Patient expected to die within 48 hours of admission to ICUKnown allergy to components of NucleoCaptureCurrent Participation in another interventional clinical trialPregnancy (as established by the presence of beta human chorionic gonadotropin in urine or blood)