RecruitingNAINTERVENTIONAL

Remote Ischemic Preconditioning and Postoperative Neuronal Injury

The SHIELD study is investigating a simple and gentle treatment called 'Remote Ischemic Preconditioning' (RIPC) before non-heart surgery. This treatment involves briefly and repeatedly restricting blood flow to an arm using a cuff, similar to having your blood pressure taken. We want to see if this can help protect your brain from potential injury that can sometimes happen after surgery. We're comparing people who have this arm treatment the day before surgery with those who receive standard care. To see if it works, we'll be measuring a specific substance in your blood (called NfL) in the first two days after your operation. This study is for people aged 50 and over who are having planned non-heart surgery and are thought to be at higher risk of experiencing confusion or memory problems after their operation.

At a glance

Status

Recruiting

Phase

Sponsor

University of Hamburg-Eppendorf

Enrolment target

216

Start

02 Mar 2026

Estimated completion

01 Sep 2027

Postoperative Neuronal Injury

What is this study about?

When you have surgery, especially if it's a big operation or you're older, there's a small chance you might experience some temporary confusion or changes in your memory afterwards. This is what doctors sometimes call 'postoperative neuronal injury'. We're always looking for new ways to reduce this risk and help people recover as smoothly as possible.

This study is trying out a gentle and simple treatment called Remote Ischemic Preconditioning (RIPC). This treatment involves using a blood pressure cuff on your arm to briefly stop and then restart blood flow a few times. It's thought to prepare your body in a way that might protect your brain during and after surgery. It's a bit like giving your body a protective 'warm-up' exercise.

The main goal of the SHIELD study is to see if this arm treatment, given the day before your surgery, can reduce the signs of brain injury after your operation. We'll be checking this by looking at levels of a substance in your blood in the first two days after surgery. We want to find out if RIPC can make a positive difference for patients having non-heart surgery.

Key takeaways

The SHIELD study explores a simple arm treatment to protect the brain during surgery.
It's for people aged 50+ having certain non-heart surgeries.
The treatment involves a blood pressure cuff on the arm, given the day before surgery.
We're checking blood tests after surgery to see if the treatment helps.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for volunteers aged 50 and over who are scheduled to have a planned, non-heart-related surgery under general anaesthetic. It's particularly welcoming people who might be at a slightly higher risk of experiencing confusion or memory changes after surgery.

You might be considered higher risk if you are 65 or older, have certain long-term health conditions, are taking more than five regular medications, your surgery is expected to last longer than three hours, or if you've been feeling down or depressed.

There are also some reasons why you might not be able to join. For example, if you have severe circulation problems in your arms, have had recent surgery or injuries to your arm, or have certain very recent heart problems or previous brain surgery. We also can't include people who are already experiencing confusion or serious memory problems, or who have previously taken part in this specific SHIELD study.

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 50 years old or older?
Are you scheduled for a planned surgery that is NOT on your heart?
Will you be having general anaesthesia for your surgery?
Do you have two or more risk factors for confusion after surgery (e.g., age 65+, 5+ medications, long surgery, certain health conditions)?
Do you have healthy arms for a blood pressure cuff?
Have you NOT had serious heart problems or surgery in the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups. One group will receive the Remote Ischemic Preconditioning (RIPC) treatment, and the other will receive standard care. If you're in the RIPC group, on the day before your surgery, a blood pressure cuff will be placed on your upper arm. This cuff will inflate and deflate several times, briefly tightening and then loosening, which usually takes about 30 minutes in total. This will happen while you're still in the hospital or clinic.

After your surgery, we'll take a few small blood samples in the first two days. These samples will help us measure the substance in your blood that indicates brain health. We'll also ask you some simple questions to check for any confusion or changes in your memory during your hospital stay, which is part of your normal post-operative care. There are no extra hospital visits required beyond your planned surgery and recovery period. The total duration of your active involvement will be limited to your hospital stay for surgery and the two days immediately afterwards.

Potential risks and benefits

Taking part in this study may or may not directly benefit you personally. We hope that the Remote Ischemic Preconditioning treatment could help reduce the risk of confusion or memory issues after surgery, but we can't guarantee this – that's what the study aims to find out. The risks associated with the RIPC treatment are generally low; some people might experience minor discomfort, bruising, or numbness in the arm during the cuff inflations, similar to having your blood pressure taken. There's also a small additional risk from the extra blood samples taken. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

University Medical Center Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What exactly is Remote Ischemic Preconditioning (RIPC)?

It's a simple, non-invasive treatment where a blood pressure cuff on your arm is inflated and deflated several times. It's thought to protect organs, including the brain, during stressful events like surgery.

Will I know if I'm getting the RIPC treatment or standard care?

No, you won't know if you're receiving RIPC or standard care. This is to ensure the study results are as fair and unbiased as possible.

How long does the RIPC arm treatment take?

If you receive the RIPC treatment, it will involve several cycles of cuff inflation and deflation on your arm, lasting about 30 minutes in total.

Why are you taking extra blood tests after surgery?

The extra blood tests are to measure a substance called NfL, which can give us information about how your brain has responded to surgery. This helps us understand if the RIPC treatment works.

What if I change my mind about participating?

You are free to withdraw from the study at any time, for any reason, without it affecting your medical care or relationship with your healthcare team.

How to find out more

Alina Bergholz

a.bergholz@uke.de 004940 7410 0 Official trial record

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