SepsisNUC-CAPNCT05647096
Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis
A study testing NucleoCapture device in people with Sepsis and Respiratory Failure, run by Santersus AG at 9 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis, Respiratory Failure
- What is being tested?
- NucleoCapture device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 1 Jul 2025to 28 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 25Show fewer
- 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)
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
United Kingdom5 sites
Queen Elizabeth Hospital Birmingham
Birmingham
Mansoor Bangash
Royal Infirmary of Edinburgh
Edinburgh
Thomas Craven
Liverpool University Hospital
Liverpool
Ben Morton
Guy's and St Thomas' Hospital
London
Marlies Ostermann
Duncan Wyncoll
University College London
London
David Brealey
Mervyn Singer
Germany3 sites
University of Bonn
Bonn
Christian Bode
Technical University Dresden
Dresden
Peter Spieth
Hannover Medical School
Hannover
Klaus Stahl
Julius Schmidt
About this study
Official title: Safety, Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis
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.
Read the detailed description
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.
- Conditions
- Sepsis, Respiratory Failure
- Being tested
- NucleoCapture device
- Keywords
- Sepsis, Respiratory failure
- Medical subject headings
- Sepsis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NucleoCapture deviceDevice
100ml NucleoCapture selective DNA adsorber
| Study group | Role | What they receive |
|---|---|---|
| NucleoCapture Treatment | Experimental | 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. Receives: Device: NucleoCapture device |
| Standard of Care | No intervention | Participants in the Standard of Care arm will receive standard medical care alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 6 hours from the baseline (pre-column) plasma
Secondary outcomes (2)
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
Measured: 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
Measured: From date of randomisation to day 21 for organ support and day 28 for survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jul 2025 (estimated)
- Primary completion5 May 2027 (estimated)
- Study completion28 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the interventional treatment arm (SOC plus NucleoCapture) or the SOC treatment arm in a 2:1
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santersus AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ISS AG
- Responsible party
- Sponsor
- Investigators
- Andrew Aswani, Principal investigator, Santersus AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647096
- Sponsor's protocol ID
- SAN/01/2022
- Acronym
- NUC-CAP
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No