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.
This study investigates the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in patients with sepsis and respiratory failure. Sepsis is a common condition in hospital settings and is associated with high rates of morbidity and mortality and despite ongoing development in the treatment and supportive care of sepsis, mortality remains considerable. cfDNA/NET therapeutic apheresis with NucleoCapture is indicated for the treatment of sepsis and for the treatment/prevention of septic shock. Participants will be randomised to receive either standard of care (SOC) or SOC plus NucleoCapture treatment, SOC will be according to the current guidelines described by the Surviving Sepsis Campaign: international guidelines for the management of sepsis and septic shock. Participants in the SOC plus NucleoCapture arm will receive one treatment session with NucleoCapture per day, for the first three days. Each treatment session with NucleoCapture will last for up 6 hours, aiming to treat 4.5 plasma volumes. Treatment sessions with NucleoCapture treating less than 3.5 plasma volumes will be counted as incomplete and the treatment session will be repeated on the following day, up to day 5 maximum. Assessments and tests will take place for all participants whilst in Intensive Care Unit (ICU) on days 1 to 5, day 7, day 14, day 21 and day 28. Participants transferred to ward-based care before day 28 will receive no further study assessment visits from the point of transfer to ward-based care, apart from day 28 in which participants will receive a final study assessment visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
100ml NucleoCapture selective DNA adsorber
University of Bonn
Bonn, Germany
Technical University Dresden
Dresden, Germany
Hannover Medical School
Hannover, Germany
University of Zurich
Zurich, Switzerland
To demonstrate the NucleoCapture column reduces the amount of cfDNA/NETs in the plasma of participants with sepsis and respiratory failure
The mean reduction of an expected ≥50% of the net amount of cfDNA/NETs across the NucleoCapture column at the end of each NuceoCapture treatment session
Time frame: Within 6 hours from the baseline (pre-column) plasma
Mean reduction in circulating cfDNA/NETs measured by circulating blood levels of nucleosomes (H.3.1)
Mean relative reduction of circulating blood cfDNA/NETs at the end of a complete treatment session with NucleoCapture compared to the change in the mean levels of cfDNA/NETs over a 6 hour period in the SOC treatment arm
Time frame: Before and after treatment with the NucleoCapture column and at the start and end of a 6 hour period in the SOC treatment arm
The clinical benefit of the NucleoCapture column in participants with sepsis and respiratory failure
Change in organ support and survival
Time frame: From date of randomisation to day 21 for organ support and day 28 for survival
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Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Liverpool University Hospital
Liverpool, United Kingdom
Guy's and St Thomas' Hospital
London, United Kingdom
University College London
London, United Kingdom