RecruitingNAINTERVENTIONAL

Remote Ischemic Preconditioning in Septic Patients

This study is investigating a technique called Remote Ischemic Preconditioning (RIPC) for very unwell patients who have sepsis, a severe infection. Sepsis can often lead to kidney damage, and currently, there isn't a proven way to stop this from happening or make it less severe. RIPC involves briefly tightening a cuff on a patient's arm three times, similar to how a blood pressure cuff works. The researchers want to find out if this simple procedure can protect the kidneys and reduce the chances of them getting damaged. They will check for signs of kidney damage using special tests in the urine. The overall goal is to improve care for critically ill patients by preventing kidney problems.

At a glance

Status

Recruiting

Phase

Sponsor

Universität Münster

Enrolment target

Start

11 May 2023

Estimated completion

01 Jan 2026

Critically Ill Acute Kidney Injury Sepsis

What is this study about?

This study is about helping critically ill patients who have a serious condition called sepsis. Sepsis is a very severe reaction to an infection that can affect many parts of the body, including the kidneys. When someone is critically ill with sepsis, their kidneys can sometimes get damaged, a problem called acute kidney injury (AKI). At the moment, doctors don't have a specific medicine or treatment that can reliably prevent or treat this kidney damage.

The researchers are looking at a simple method called Remote Ischemic Preconditioning (RIPC). This involves using a blood pressure cuff on a patient's arm and briefly tightening it, then releasing it, three times. This temporary restriction of blood flow, followed by its return, is thought to trigger the body's natural protective mechanisms, which might then help protect other organs, like the kidneys, from damage. It's a bit like giving the body a gentle practice run at dealing with stress.

The main goal of this study is to see if this RIPC method can reduce the chances of critically ill patients with sepsis developing acute kidney injury, or at least make it less severe if it does happen. They will be measuring certain markers in the patient's urine that can indicate early kidney damage. If successful, this could become a widely used and straightforward way to protect the kidneys of very unwell patients.

Key takeaways

This study investigates a simple method to protect kidneys in very ill sepsis patients.
The method, RIPC, involves briefly restricting blood flow to an arm.
Currently, there are no proven treatments to prevent kidney damage in sepsis.
The study aims to see if RIPC can reduce kidney problems.
Participation involves a brief procedure and standard monitoring.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, people must be adults aged 18 or older. They need to be very ill with sepsis that started within the last 12 hours. They also must be on a breathing machine (ventilator) for at least 24 hours (without certain strong sedatives) or receiving medication to help support their blood pressure. Patients also need to be expected to stay in intensive care for at least three days. Before joining, patients or their family will be asked to give their written permission.

There are also reasons why someone might not be able to join. For example, if they already have kidney damage or certain kidney diseases like glomerulonephritis, or if their kidneys are severely unwell with very low function. Patients who are on long-term dialysis or who have had a kidney transplant in the last year cannot participate. Also, pregnant or breastfeeding women, or those taking certain diabetes or other specific medications, cannot join. Patients who are already in another study involving kidney outcomes or have a 'do not resuscitate' order are also not eligible.

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 or over?
Are you critically ill with sepsis that started recently (within 12 hours)?
Are you either on a breathing machine or receiving blood pressure support medicine?
Do you not have existing severe kidney disease or kidney transplant in the last year?
Are you not pregnant or breastfeeding?
Are you able to agree to join the study, or can your close family provide consent?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the main intervention will be the Remote Ischemic Preconditioning (RIPC) procedure. This involves having a blood pressure cuff placed on your upper arm. The cuff will be inflated and deflated three times, each for a short period, temporarily restricting blood flow. Some participants will have a 'sham' procedure, where the cuff is put on but not inflated, so neither you nor the doctors know which group you are in. You will have regular checks, including blood and urine tests, as part of your standard intensive care treatment. The study will look at your kidney function and other health markers. The duration of your participation will depend on your time in intensive care and recovery, but the RIPC procedure itself is very brief.

Potential risks and benefits

Participating in this study might offer a potential benefit if the Remote Ischemic Preconditioning (RIPC) helps protect your kidneys, though this is not guaranteed as it is an investigational approach. There are currently no known serious risks associated with the RIPC procedure; you might feel a temporary tightness or discomfort in your arm when the cuff is inflated, similar to having your blood pressure taken. The other tests are standard within intensive care. You have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Verified postcode
Münster, Germany· Recruiting

Common questions

What is sepsis?

Sepsis is a serious and life-threatening condition where the body's response to an infection damages its own tissues and organs.

What is 'acute kidney injury'?

Acute kidney injury (AKI) means your kidneys suddenly stop working as well as they should, which is a common issue when someone is very ill.

What is Remote Ischemic Preconditioning (RIPC) like?

It's like having your blood pressure taken, but the cuff will be tightened and released three times for short periods on your arm. It might feel a bit tight but shouldn't be painful.

Will I know if I'm getting the real treatment or the dummy treatment?

No, neither you nor your doctors will know if you're getting the active RIPC or the 'sham' (dummy) treatment. This is to ensure the study results are fair.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your medical care.

How to find out more

Melanie Meersch-Dini, MD

meersch@uni-muenster.de +49-251-8347255 Official trial record

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