RecruitingNAINTERVENTIONAL

A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine

This study aims to understand why some people develop kidney problems, called acute kidney injury (AKI), after heart surgery. AKI is common and can be serious. Researchers will look at blood and urine samples from patients before and after their heart surgery to find specific markers in the body that might show early signs of kidney issues. They'll compare samples from people who develop AKI with those who don't. The goal is to learn more about how AKI happens, which could lead to better ways to prevent and treat it in the future. Participants will undergo their normal medical care and won't receive any new treatments as part of the study.

At a glance

Status

Recruiting

Phase

Sponsor

Bayer

Enrolment target

200

Start

03 Feb 2025

Estimated completion

31 Jan 2027

Cardiac Surgery-associated Acute Kidney Injury

What is this study about?

Heart surgery is a major operation, and sometimes, the kidneys can be affected afterwards, leading to a condition called acute kidney injury (AKI). This means the kidneys stop working as well as they should. It's quite common after heart surgery, and some things can increase the risk, such as being older or having existing health problems like kidney disease or diabetes. Also, the longer a heart-lung machine is used during surgery, the higher the chance of developing AKI.

In this study, our main goal is to find out exactly how AKI develops in people who have heart surgery. We'll be looking closely at specific signs in the body, called 'biomarkers,' which can be found in blood and urine. We'll collect samples before and after surgery, especially focusing on the first few hours and days. By comparing these markers in people who get AKI with those who don't, we hope to spot early warning signs.

Understanding these early signs is really important. It could help doctors to identify people at risk sooner and might even lead to new treatments or ways to prevent AKI from happening in the first place. The people in this study will be those who are already scheduled for heart surgery by their own doctors and might be at risk of developing AKI. They will receive their usual medical care, and no new treatments are given as part of the study itself.

Key takeaways

Study aims to understand why kidneys are sometimes affected after heart surgery.
No new treatments are given; you'll receive your usual hospital care.
Researchers will collect extra blood and urine samples.
Participation lasts up to 2 months.
Your involvement helps improve understanding for future patients.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must also be planning to have certain types of heart surgery that involve using a heart-lung machine, such as operations on heart valves or major heart bypass surgery. Additionally, participants should have some level of chronic kidney disease, meaning your kidney function is a bit reduced but not severely so.

There are also some reasons why you might not be able to join. For example, if your surgery is an emergency, or if you have severe anaemia (low iron in your blood). You also can't take part if you have an active infection, are taking certain strong medicines to suppress your immune system, or have recently had major surgery or a kidney injury. If you've had a kidney transplant or need regular kidney dialysis, you won't be suitable for this study.

Also, if you're expected to receive certain contrast dyes for scans around the time of your surgery, or if you're already in another study involving a new medication, you wouldn't be able to join this one. The study doctor will make the final decision if they think participation wouldn't be right for you, for example, if you have certain autoimmune conditions affecting your kidneys or heart.

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 18 years old or older?
Are you having specific heart surgery with a heart-lung machine?
Do you have some existing kidney disease (not severe)?
Is your surgery planned (not an emergency)?
Are you NOT taking strong immune-suppressing medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't receive any new treatments or medications. You will still have your heart surgery and all related medical care exactly as your own doctors have planned. What's different is that the study team will be involved alongside your usual care. They will collect blood and urine samples from you before and after your surgery. They will also look at your medical notes and test results from your time in hospital. The team will keep an eye on your overall health throughout the study period. Your involvement in the study will last for up to 2 months in total.

Potential risks and benefits

The main benefit of taking part in this study is helping researchers gain a better understanding of how kidney problems develop after heart surgery. This knowledge could help improve care for future patients. There are no direct medical benefits for you personally as you won't be receiving new treatments. As for risks, you'll have extra blood and urine samples collected, which carries minor discomfort and a very small risk of bruising. You can choose to leave the study at any time without it affecting your medical care. Your decision to take part, or not, is entirely yours.

Locations (4)

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

Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
Verified postcode
Bad Oeynhausen, Germany· Recruiting
Royal Papworth Hospital NHS Foundation Trust | Royal Papworth Hospital - Cardiac Surgery
Verified postcode
Cambridge, United Kingdom· Recruiting
Guy's and St Thomas' NHS Foundation Trust | Harefield Hospital - Cardiology
Verified postcode
Harefield, United Kingdom· Not yet recruiting
Guy's and St Thomas' NHS Foundation Trust | Guy's & St Thomas' Hospital - Department of Critical Care & Nephrology
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'acute kidney injury' (AKI)?

AKI means your kidneys suddenly stop working as well as they should, often after a major event like heart surgery.

Will I get new medicine as part of this study?

No, you will not receive any new medicines or treatments. You will get your usual medical care for your heart surgery.

What is a 'biomarker'?

A biomarker is something found in your blood or urine that can give doctors clues about what's happening in your body, like a sign of disease.

How long will I be involved in the study?

You'll be part of the study for up to 2 months from when you join.

Who can see my personal information?

Your medical records will be kept private. Only the study team and authorised professionals will have access to information about you.

How to find out more

Bayer Clinical Trials Contact

clinical-trials-contact@bayer.com (+)1-888-84 22937 Official trial record

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