RecruitingNAINTERVENTIONAL

Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock

This study is investigating a new treatment named therapeutic plasma exchange (TPE) for patients critically ill with septic shock. Septic shock is a life-threatening condition where the body's reaction to an infection causes organs to fail. Current treatments mainly support the body, but researchers believe TPE might help by removing harmful substances from the blood that cause organ damage. This trial aims to see if adding TPE to standard care can improve recovery and reduce the high risk of death for these patients. It's a randomised study, meaning some patients will get TPE alongside usual care, and others will only get usual care, to compare the results fairly.

At a glance

Status

Recruiting

Phase

Sponsor

Hannover Medical School

Enrolment target

274

Start

19 Feb 2025

Estimated completion

01 Apr 2028

Septic Shock

What is this study about?

Imagine your body's alarm system going off because of an infection. Normally, this helps you fight it. But sometimes, this alarm system goes into overdrive, causing more harm than good, leading to what doctors call 'septic shock'. In septic shock, this extreme reaction can damage organs like your heart, lungs, and kidneys, which is very serious and can be life-threatening.

Doctors know that patients often don't die directly from the infection itself, but from this overwhelming response from their own body. Because of this, there's a real need for new treatments that can calm this extreme reaction and protect the organs. Current treatments mostly focus on supporting the body while it fights the infection.

This study is looking at a treatment called Therapeutic Plasma Exchange (TPE). You might have heard of 'plasma' – it's the liquid part of your blood. In TPE, a machine temporarily takes some of your blood, removes the plasma which might contain harmful substances, and then returns your blood cells along with fresh plasma (or a plasma substitute). The researchers hope that by removing these harmful substances early on, TPE could help limit organ damage and improve the chances of recovery for people with severe septic shock. This is an important study because if TPE works, it could significantly improve care for these very unwell patients.

Key takeaways

The study is investigating a new treatment (TPE) for severe blood poisoning (septic shock).
Septic shock is a life-threatening condition where the body's reaction to infection harms organs.
TPE aims to remove harmful substances from the blood to protect organs.
The goal is to see if TPE can improve recovery and reduce the high death rate from septic shock.
Participation involves either standard care or standard care plus TPE, with close medical monitoring.

Who may be eligible?

To join this study, you would need to be an adult between 18 and 80 years old, and have recently developed septic shock (within the last 24 hours) that is severe enough to require certain medications to maintain blood pressure.

There are some reasons why you might not be able to join. For example, if you are pregnant, have a type of blood problem called Heparin-induced thrombocytopenia, or have had a bad reaction to fresh frozen plasma in the past, you would not be eligible. If your infection started in your bladder or kidneys, you also wouldn't be able to take part.

The medical team will carefully check all these points to see if this study is right for you.

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 80 years old?
Have you been diagnosed with septic shock within the last 24 hours?
Is your septic shock severe enough to need medication to keep your blood pressure up?
Are you able to have a special IV line for the blood filtering treatment?
Are you pregnant? (If yes, you cannot join.)
Do you have a history of bad reactions to blood plasma treatments?

Answer every question to see your result.

What does participation involve?

This study is a ‘randomised’ trial, meaning if you qualify, you will be assigned by chance to one of two groups: one group will receive the standard care for septic shock (the usual treatments given) and the other group will receive TPE in addition to the standard care. Because it's an 'open-label' study, both you and your doctors will know which treatment group you are in. Taking part would involve regular checks of your health, blood tests, and monitoring while you are in the hospital. The TPE treatment itself involves a machine that filters your blood, similar to kidney dialysis. The duration of your participation will depend on your hospital stay and recovery.

Potential risks and benefits

Participating in any study has potential benefits and risks. A potential benefit of this study is that TPE might improve your condition and recovery from septic shock, though this is not guaranteed as it's still being investigated. Potential risks of TPE can include reactions to the new plasma, changes in blood pressure, or temporary discomfort during the procedure. Your medical team will monitor you closely for any side effects. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (25)

University Hospital Innsbruck
Verified postcode
Innsbruck, Austria· Not yet recruiting
University Hospital Vienna
Verified postcode
Vienna, Austria· Not yet recruiting
St. Joseph Hospital
Verified postcode
Berlin, Germany· Not yet recruiting
University Hospital Berlin Charite
Verified postcode
Berlin, Germany· Not yet recruiting
University Hospital Bonn
Verified postcode
Bonn, Germany· Recruiting
Hospital Braunschweig
Verified postcode
Braunschweig, Germany· Not yet recruiting
Hospital Bremerhaven
Verified postcode
Bremerhaven, Germany· Not yet recruiting
Hospital Cologne Meerheim
Verified postcode
Cologne, Germany· Not yet recruiting
University Hospital Cologne
Verified postcode
Cologne, Germany· Not yet recruiting
University Hospital Erlangen
Verified postcode
Erlangen, Germany· Not yet recruiting
University Hospital Essen
Verified postcode
Essen, Germany· Not yet recruiting
University Hospital Halle
Verified postcode
Halle, Germany· Active not recruiting

Common questions

What is septic shock?

Septic shock is a very severe form of blood poisoning where an infection in your body causes your organs to start failing, leading to dangerously low blood pressure.

What is Therapeutic Plasma Exchange (TPE)?

TPE is a medical procedure where some of your blood plasma, which carries many substances, is removed and replaced with fresh plasma, or a similar fluid. It's often used to treat conditions caused by harmful substances in the plasma.

Why are doctors studying TPE for septic shock?

Doctors believe removing harmful substances from the blood early might help reduce organ damage caused by the body's extreme reaction during septic shock, potentially improving patient outcomes.

Will I know if I'm getting TPE or just standard care?

Yes, this is an 'open-label' study, which means both you and your doctors will know whether you are receiving TPE in addition to standard care, or just standard care.

What if I experience side effects during the study?

Your medical team will closely monitor you for any side effects or discomfort during the TPE procedure and throughout your participation in the study.

How to find out more

Sascha David, Prof. Dr.

sascha.david@usz.ch +41 44 255 8653 Official trial record

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