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
Parallel
NucleoCapture device
Device100ml NucleoCapture selective DNA adsorber.
The amount of cfDNA/NETs in the plasma of patients with severe acute pancreatitis after each NucleoCapture treatment.
The change in the levels of cfDNA/NETs across the NucleoCapture column at the end of each NucleoCapture treatment session.
The amount of cfDNA/NETs in the circulating blood in patients after treatment with NucleoCapture compared to standard of care.
The change in the levels of circulating cfDNA/NETS at the end of each NucleoCapture treatment session.
Change in organ in support
Change in organ support will be assessed by the combined change in Inotrope e.g. norepinephrine dose, lactate, urine output, Horowitz index and oxygenation index compared to standard of care
28-day survival
Survival up to 28 days
ICU length of stay
The length of stay in the ICU
Exploratory evaluation of the correlation between NucleoCapture treatment and levels of routine biomarkers.
Routine organ function, haematology, coagulation and inflammation biomarkers will be measured.
Exploratory evaluation of the correlation between NucleoCapture treatment and levels of non-routine biomarkers.
Non-routine biomarkers of inflammation and coagulation will be measured.
Device handling and usability.
Usability and handling of the device will be assessed in the intervention arm using a questionnaire.
Patient reported outcome (PROMs) - PAN PROMISE acute pancreatitis symptom scale
Quantify the symptoms of acute pancreatitis via PROM.
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Liverpool University Hospitals NHS Foundation Trust
Lead sponsor
Santersus AG
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
