Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis
NCT ID: NCT05647096
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
73 participants
INTERVENTIONAL
2025-07-01
2027-05-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NucleoCapture Treatment
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.
NucleoCapture device
100ml NucleoCapture selective DNA adsorber
Standard of Care
Participants in the Standard of Care arm will receive standard medical care alone.
No interventions assigned to this group
Interventions
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NucleoCapture device
100ml NucleoCapture selective DNA adsorber
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
No
Sponsors
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ISS AG
UNKNOWN
Santersus AG
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Aswani
Role: PRINCIPAL_INVESTIGATOR
Santersus AG
Locations
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University of Bonn
Bonn, , Germany
Technical University Dresden
Dresden, , Germany
Hannover Medical School
Hannover, , Germany
University of Zurich
Zurich, , Switzerland
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
Countries
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Central Contacts
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Facility Contacts
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Christian Bode
Role: primary
Peter Spieth
Role: primary
Klaus Stahl
Role: primary
Julius Schmidt
Role: backup
Sascha David
Role: primary
Mansoor Bangash
Role: primary
Thomas Craven
Role: primary
Ben Morton
Role: primary
Marlies Ostermann
Role: primary
Duncan Wyncoll
Role: backup
David Brealey
Role: primary
Mervyn Singer
Role: backup
Other Identifiers
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SAN/01/2022
Identifier Type: -
Identifier Source: org_study_id