Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating cfDNA/NETs in Subjects With Sepsis (NUC-CAP)
Sepsis, Respiratory Failure
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Respiratory failure
Eligibility Criteria
Inclusion Criteria: Adult patients aged 18-75 Proven or suspected respiratory sepsis aetiology Acute respiratory failure currently requiring invasive mechanical ventilation for not more than 48 hours duration Horowitz Index for Lung Function (Pa02/Fi02 Ratio) ≤200mmHg or ≤26.6kPa Sequential organ failure assessment score (SOFA) ≥4 and ≤ 14 Have 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 hours The 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 failure Norepinephrine dose > 0.60 μg/kg/min Use of epinephrine Concomitant cardiogenic shock, clinically suspected or CI<2.2 if measured Use of dobutamine, epinephrine, phosphodiesterase inhibitors or levosimendan Coagulopathy as defined by platelet count <50 Calculated 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-volume Long term oxygen therapy or home oxygen use Liver cirrhosis (histologically proven or clinically suspected) Active bleeding Citrate intolerance if citrate is required for therapeutic apheresis Heparin allergy if heparin is required for therapeutic apheresis Metastatic disease with life expectancy of <12 months and ECOG score of at least 2 Haematological malignancy if not in remission Solid organ transplant and concomitant use of immunosuppression Dialysis dependent Chronic Kidney Disease (CKD Stage 5-D) Prior use of cardiopulmonary resuscitation (CPR) in index admission Requirement for extracorporeal membrane oxygenation (ECMO) Patient expected to die within 48 hours of admission to ICU Known allergy to components of NucleoCapture Current Participation in another interventional clinical trial Pregnancy (as established by the presence of beta human chorionic gonadotropin in urine or blood)
Sites / Locations
- University of Bonn
- Technical University Dresden
- Hannover Medical School
- University of Zurich
- Queen Elizabeth Hospital Birmingham
- Royal Infirmary of Edinburgh
- Liverpool University Hospital
- Guy's and St Thomas' Hospital
- University College London
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
NucleoCapture Treatment
Standard of Care
Participants in the NucleoCapture treatment arm will receive Standard of Care plus three treatment sessions with the NucleoCapture treatment device. The device consists of 100ml NucleoCapture selective adsorber.
Participants in the Standard of Care arm will receive standard medical care alone.