RecruitingNAINTERVENTIONAL

Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.

This study is for very sick patients in intensive care who need machines like dialysis for kidney problems or ECMO for heart and lung support. Often, their bodies react strongly to severe illness or injury, causing inflammation. Researchers want to see if a special blood filter, called HA380, can help. This filter would be connected to the patient's existing dialysis or ECMO machine. The aim is to find out if using this filter is practical and if it could help patients recover more quickly, potentially reducing the time they spend on these machines, breathing support, blood pressure medication, and in intensive care. This is a pilot study to see if a larger study would be worthwhile.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospitals, Leicester

Enrolment target

Start

02 Sep 2024

Estimated completion

31 Oct 2026

Acute Kidney Injury ARDS Inflammation Extracorporeal Circulation; Complications

What is this study about?

When people become extremely unwell due to serious infections, major injuries, or big operations, their bodies can sometimes overreact. This overreaction is called inflammation, and it can cause problems with important organs like the kidneys, heart, or lungs. To help these organs, patients might need special machines, such as dialysis for their kidneys or ECMO (Extracorporeal Membrane Oxygenation) for their heart and lungs. These machines take over some of the work the organs can't do themselves.

This study is looking at a device called the HA380 column, which is a type of blood filter. Researchers believe that by filtering the blood, this device might be able to remove some of the substances that cause this harmful inflammation. The idea is that if we can reduce this overreaction, patients might recover more quickly from their illness. The HA380 filter would be connected directly to the dialysis machine or ECMO machine that the patient is already using.

The main goal of this particular study is to see if it's practical to use the HA380 filter in real-life intensive care settings. They also want to understand if it has any effect on how long patients need to stay on dialysis, ECMO, or a breathing machine. They'll also look at how long patients need medicines to support their blood pressure and how long they stay in intensive care. This is a first step to see if a larger study on this treatment would be a good idea.

Key takeaways

This study explores a blood filter (HA380) for very sick intensive care patients.
The filter aims to reduce harmful inflammation.
It connects to existing dialysis or ECMO machines.
The study checks if using the filter is practical and its effects on recovery time.
It's a pilot study to see if a larger study is needed.
Participation involves close monitoring, which is standard in intensive care.

Who may be eligible?

To join this study, you would need to be between 18 and 65 years old. You would also need to be very unwell, diagnosed with a severe infection (sepsis), serious injury, or major surgery, and experiencing serious lung problems (ARDS). Importantly, you would be already receiving life support, specifically dialysis for your kidneys or ECMO for your heart and lungs, and needing medication to support your blood pressure. You would also need to have started this life support within the last 72 hours and have signs of high inflammation or a high lactate level in your blood.

There are also reasons why you might not be able to join. For example, if you have severe long-term kidney or breathing problems, or advanced heart failure. You also wouldn't be able to join if you are pregnant, expected to die very soon, or already receiving other treatments that affect your immune system, like plasma exchange. Finally, if you've recently taken part in another study with a new medical product within the last 12 weeks, you wouldn't be able to join this one.

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 between 18 and 65 years old?
Are you in intensive care due to severe infection, injury, or major surgery?
Do you need dialysis for kidney problems or ECMO for heart/lung support?
Do you need medicines to support your blood pressure?
Have you started dialysis/ECMO within the last 3 days?
Do you have signs of high inflammation in your blood?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the HA380 filter will be connected to your existing dialysis or ECMO machine. This is a standard way to add blood filters in intensive care. The study will monitor your condition very closely, which is already standard during intensive care. Researchers will collect information on how long you need the ventilation, dialysis, or ECMO machines, how long you need blood pressure support, and your overall time in the intensive care unit. The total duration of your participation in the study will depend on how long you need intensive care and the support machines.

Potential risks and benefits

This study aims to explore if the HA380 filter could help reduce inflammation and potentially lead to a quicker recovery. While there's no guarantee of direct benefit from taking part, information gathered could help future patients. The HA380 filter would be connected to machines you are already using, and doctors will carefully monitor for any side effects. As with any medical procedure in critically ill patients, there are always risks, but the study team will take every precaution. You would have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

University Hospitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is inflammation and why is it a problem?

Inflammation is your body's natural response to injury or illness. However, too much inflammation can make you even sicker by damaging organs. This study aims to reduce that harmful overreaction.

What is the HA380 column?

It's a special blood filter, like a tiny sponge, designed to remove substances from your blood that cause inflammation. It would be connected to your existing life support machine.

Will the HA380 column be attached to my body?

The HA380 column itself is not directly attached to your body. Instead, it’s connected to the tubes of the dialysis or ECMO machine you are already using to filter your blood.

Is this a new treatment?

While similar devices exist, the HA380 column is being specifically studied in this way for very ill patients. This is a 'pilot' study, meaning it's an early step to gather information.

Can I leave the study if I change my mind?

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

How to find out more

Hakeem Yusuff, MBBS

hakeem.yusuff1@nhs.net 01162583816 Official trial record

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