Not yet recruitingNAINTERVENTIONAL

Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis

This study is looking at a new treatment called NucleoCapture for patients in intensive care with sepsis and serious breathing difficulties. Sepsis is a severe reaction to infection, and despite current treatments, it can be very dangerous. The NucleoCapture device helps to filter the blood, aiming to reduce harmful substances (like cell-free DNA and NETs) that can make sepsis worse. We want to see if adding this device to standard care is safe, well-tolerated, and effective. Some patients will receive standard care, while others will get standard care plus the NucleoCapture treatment for a few days, with regular checks over about a month. This research aims to find better ways to help people recover from sepsis.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Santersus AG

Enrolment target

Start

01 Jul 2025

Estimated completion

28 May 2027

Sepsis Respiratory Failure

What is this study about?

Sepsis is a very serious condition where your body's response to an infection damages its own tissues and organs. It's quite common in hospitals, and even with the best medical care, it can be life-threatening. When you have sepsis, certain substances, like cell-free DNA and something called Neutrophil Extracellular Traps (NETs), can build up in your blood. Scientists believe these substances might make sepsis worse or lead to complications like septic shock.

This study is testing a new device called NucleoCapture. It works a bit like kidney dialysis, where your blood is gently circulated through a machine outside your body. The NucleoCapture device is designed to filter out these specific harmful substances (cell-free DNA and NETs) from your blood. The idea is that by reducing these substances, we might be able to help your body recover better from sepsis and prevent serious complications.

We want to find out if using the NucleoCapture device alongside the usual standard medical care for sepsis is safe, doesn't cause too many side effects, and is effective in improving the condition of patients. The study will compare patients who receive the standard care with those who receive standard care plus the NucleoCapture treatment to see if there's a difference in their recovery and well-being.

Key takeaways

Tests a new device (NucleoCapture) for sepsis and breathing problems.
Aims to filter harmful substances from the blood.
Compares the new treatment with standard care.
Participation involves daily treatments for 3 days (if in that group) and assessments for up to 28 days.
The study assesses safety, side effects, and how well the device works.
Involves patients in intensive care (ICU).

Who may be eligible?

This study is looking for adults aged between 18 and 75 who are currently in intensive care with sepsis that has affected their breathing. They must need a breathing machine (ventilator) and have been using it for no more than 48 hours when they join the study. Doctors will also check specific scores related to lung function and organ health to make sure participants meet the criteria.

There are certain situations that would mean someone couldn't join the study. These include if they are expected to need breathing support for less than 48 hours, or if they are already receiving other special blood filtering treatments for sepsis. Also, patients with very severe organ failure in other areas, certain heart problems, severe bleeding, or specific allergies to medications used in the treatment (like citrate or heparin) would not be able to participate. If someone has certain long-term health conditions like liver cirrhosis or some cancers, they would also not be eligible. The hospital team will check all these details carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18-75?
Do you have sepsis affecting your breathing and need a ventilator?
Have you been on the breathing machine for no more than 48 hours?
Are you able to provide consent or have a legal representative who can?
Do you have specific organ function and health scores that meet the study requirements?
Do you not have certain other severe medical conditions or allergies mentioned by the doctors?

Answer every question to see your result.

What does participation involve?

If you or your representative agree to take part, you will be randomly assigned to one of two groups: either you'll receive the standard care for sepsis, or you'll receive standard care plus treatment with the NucleoCapture device. Those in the NucleoCapture group will have one treatment session per day for the first three days, with each session lasting up to 6 hours. If a session doesn’t remove enough plasma (the liquid part of your blood), it might be repeated the next day, up to a maximum of five days.

During your time in the Intensive Care Unit (ICU), regular assessments and tests will be carried out on days 1, 2, 3, 4, 5, 7, 14, 21, and 28. If you move out of the ICU and onto a regular ward before day 28, the study visits will stop until day 28, when you’ll have a final check-up. The total duration of active study participation with tests is about 28 days.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. While this new device could potentially help improve recovery from sepsis, it is still being investigated, and the benefits are not guaranteed. There might be side effects from the device or the procedures involved, similar to other intensive care treatments, which your care team will discuss in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Bonn
Verified postcode
Bonn, Germany
Technical University Dresden
Verified postcode
Dresden, Germany
Hannover Medical School
Verified postcode
Hannover, Germany
University of Zurich
Verified postcode
Zurich, Switzerland
Queen Elizabeth Hospital Birmingham
Verified postcode
Birmingham, United Kingdom
Royal Infirmary of Edinburgh
Verified postcode
Edinburgh, United Kingdom
Liverpool University Hospital
Verified postcode
Liverpool, United Kingdom
Guy's and St Thomas' Hospital
Verified postcode
London, United Kingdom
University College London
Verified postcode
London, United Kingdom

Common questions

What is sepsis?

Sepsis is a life-threatening complication of an infection where the body's immune system overreacts and starts to damage its own tissues and organs.

What does the NucleoCapture device do?

It's a device that filters your blood outside the body, similar to dialysis, to remove certain harmful substances that build up during sepsis, like cell-free DNA and NETs.

Will I definitely receive the new treatment?

No, participants are randomly assigned to either receive standard care or standard care plus the NucleoCapture treatment, meaning you might not receive the new treatment.

How long will I be involved in the study?

Active study assessments will last for up to 28 days from when you join. Treatment with the device, if you are in that group, usually lasts for 3 days.

Can I leave the study at any time?

Yes, you or your legal representative can decide to withdraw from the study at any point, and this will not affect your ongoing medical care.

How to find out more

Emma Barsoum

eb@santersus.com +447806820434 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.