This is a single-centre, randomised-controlled, open-label, feasibility 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 patients with severe acute pancreatitis.
Adult patients aged 18 or over
Acute pancreatitis (following revised Atlanta definition of 2 out of typical pain, serum amylase >3x normal range and/or CT/MRI imaging consistent with pancreatitis)
Any aetiology
Acute respiratory (PaO2/FiO2 <300), cardiovascular (systolic BP <90 or any inotropic therapy) or renal failure (serum creatinine >170 µmol/l, or deterioration of >50% eGFR if pre-existing renal disease or urine output <0.5ml/kg/hr for 3 consecutive hours) presenting at any point during the index admission and persistent after 12 h of fluid resuscitation, but for not more than 72 hours
The use of other non-routine extracorporeal 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).
Severe refractory vasoplegic failure
Norepinephrine dose > 0.60 μg/kg/min
Use of epinephrine
Liverpool University Hospitals NHS Foundation Trust
Lead sponsor
Santersus AG
Collaborator