RecruitingNAINTERVENTIONAL

Effect of an Intervention to Prevent Acute Kidney Injury Versus Standard Care in High-risk Patients After Major Surgery

This study aims to find better ways to prevent a serious condition called Acute Kidney Injury (AKI) after major surgery. AKI happens when your kidneys suddenly stop working as well as they should. Currently, there’s no specific medicine for AKI, so doctors usually focus on supporting the patient. This trial will test if an 'extended care bundle' – a collection of supportive treatments – can prevent AKI from becoming worse in people who are at high risk. Participants will be divided into groups based on their risk level for AKI worsening and then randomly assigned to either receive standard hospital care or this new extended care bundle. The goal is to see if this special care can help more people avoid ongoing kidney problems.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Muenster

Enrolment target

480

Start

22 Mar 2023

Estimated completion

01 Dec 2025

Acute Kidney Injury (Nontraumatic)

What is this study about?

When you have major surgery, sometimes your kidneys can get a bit of a shock and don't work as well as they should. Doctors call this Acute Kidney Injury, or AKI. While it often gets better, for some people, it can become a serious and lasting problem. Right now, there isn't a specific drug to fix AKI, so doctors focus on supportive care to help your kidneys recover.

This study wants to find out if a specific set of extra supportive care measures, which we call an 'extended care bundle,' can prevent AKI from getting worse in people who are at high risk after surgery. Researchers believe that by giving this extra care, they might be able to reduce the number of patients who develop serious, long-term kidney issues. All patients in the study will receive the usual good care you'd get in hospital, but some will also get these extra steps.

To make sure they test this idea fairly, patients will be split into different groups. Some patients will naturally be at a higher risk of their AKI getting worse, and others at a lower risk. The study will look at both these groups and then randomly decide whether they receive the standard hospital care or the extended care bundle. This helps compare the two approaches fairly and understand if the extended care bundle truly makes a difference.

Key takeaways

This study aims to improve care for Acute Kidney Injury (AKI) after surgery.
It compares standard care with an 'extended care bundle' of supportive treatments.
Participation involves close monitoring of kidney function and possibly extra care specific to the study.
You will be randomly assigned to either the standard or extended care group.
The goal is to see if the extended care can prevent AKI from getting worse.
Your involvement helps improve understanding and care for future patients.

Who may be eligible?

To join this study, you need to be an adult (age 18 or older) who has recently had major surgery and developed moderate or severe AKI (a significant but not permanent kidney problem) within three days of your operation. You also need to be able to understand the study and give your written permission to take part.

There are some reasons why you wouldn't be able to join. These include if you already have serious kidney disease that needs dialysis, have had a kidney transplant, or if you have certain infections like HIV or hepatitis. Also, if you're pregnant or breastfeeding, you can't participate.

You also can't take part if you've been involved in another study looking at drugs affecting kidney function in the last three months, or if you are in any way dependent on the study doctors or staff.

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?
Have you recently had major surgery?
Have you developed moderate or severe kidney injury since your surgery?
Are you able to provide written permission to join the study?
Do you not have advanced kidney disease requiring dialysis or a kidney transplant?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be assessed to see if you meet the study requirements. All patients in the study will receive standard hospital care. In addition, you'll have extra tests, including a blood test for a specific marker called CCL14, which helps identify your risk level for AKI getting worse. Based on this risk, you'll then be randomly placed into one of four groups. Two groups will receive the standard care, and two groups will receive the 'extended KDIGO bundle' of care. This bundle involves careful monitoring of your fluid balance and blood pressure, avoiding certain medications that might affect your kidneys, and potentially seeing a kidney specialist. The study will closely track your kidney function through regular blood and urine tests during your hospital stay. The total duration of your participation will be while you are an inpatient in the hospital recovering from your surgery and AKI.

Potential risks and benefits

Potential benefits of participating include receiving a high level of attentive care, and for those in the intervention arm, receiving an extended care package that might help prevent your kidney injury from worsening. Your participation also helps researchers learn more, which could improve care for future patients. There are no known significant risks beyond those associated with standard hospital care and recovery from surgery. You will have additional blood tests as part of the study. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital Münster; 1Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Verified postcode
Münster, Germany· Recruiting

Common questions

What is Acute Kidney Injury (AKI)?

It's when your kidneys suddenly stop working as well as they should, often after a major illness or surgery. It can be mild or severe.

What is the 'KDIGO bundle'?

It's a collection of supportive care steps doctors follow, like managing fluids, blood pressure, and avoiding harsh medicines, to help kidneys recover.

Will I get a new drug?

No, this study is testing different approaches to supportive care, not a new medication. It compares standard care with an 'extended care bundle'.

How long will I be in the study?

Your participation will be for the duration of your hospital stay while you are recovering from surgery and AKI.

What does 'randomly allocated' mean?

It means a computer will decide which treatment group you are in, like flipping a coin. Neither you nor your doctor can choose.

How to find out more

Zarbock, MD

aki@anit.uni-muenster.de +49-251-8347252 Official trial record

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