RecruitingNAINTERVENTIONAL

ImproviNg rEnal Outcomes Following Coronary angiograPhy and/or percuTaneoUs coroNary intErventions

This study, called NEPTUNE, is testing a new way to protect your kidneys if you're having heart procedures like an angiogram or a stent fitting that involve using special dye. Sometimes, this dye can cause temporary kidney problems. We want to see if giving fluids (hydration) that are specially adjusted for each patient, based on certain heart measurements and kidney health, works better than the standard fluid treatment to prevent these kidney issues. We'll also be looking at overall patient health after these procedures. The study aims to find the best way to keep your kidneys safe during these important heart treatments.

At a glance

Status

Recruiting

Phase

Sponsor

Montreal Heart Institute

Enrolment target

1,158

Start

28 Jun 2021

Estimated completion

31 Jul 2027

Contrast-Induced Acute Kidney Injury

What is this study about?

When you have a heart procedure like an angiogram or a stent fitting, doctors often use a special dye to help them see your blood vessels more clearly. For most people, this is perfectly safe. However, for a small number of people, this dye can sometimes affect their kidneys, leading to a temporary condition called Contrast-Induced Acute Kidney Injury (CI-AKI).

This study, called NEPTUNE, is looking for better ways to protect your kidneys during these procedures. We're comparing two ways of giving fluids: one is the standard approach, and the other is a new, personalised method. This personalised method adjusts the amount of fluid you receive based on specific information about your heart pressure, how much dye is used, and how well your kidneys are working before the procedure. The aim is to give you just the right amount of fluid to help prevent any kidney problems.

After the procedure, we'll check your kidney function to see if the personalised fluid plan works better than the standard plan at keeping your kidneys healthy. We'll also keep an eye on your overall health. Our goal is to find the best and safest way to perform these important heart procedures while making sure your kidneys are well protected.

Key takeaways

Study aims to protect kidneys during heart procedures using dye.
Compares a new personalised fluid plan with standard fluid care.
Fluid is given through a drip before, during, and after the procedure.
Neither you nor your doctors will know which fluid plan you receive.
Kidney function will be checked with blood tests after the procedure.
Your participation could help improve care for future patients.

Who may be eligible?

To join this study, you need to be at least 18 years old and be planning to have a heart angiogram or a stent fitting. You also need to be willing to come to study visits and be expected to live for at least another six months.

However, there are some reasons why you wouldn't be able to join. For example, if you are very unwell with certain heart problems like shock, or if you need an emergency procedure (like for a severe heart attack). You also can't participate if you've already had dye recently, have a pre-existing kidney injury, are on dialysis, or have certain severe heart valve problems or very weak heart pumping function.

Basically, the study is for people having planned heart procedures who are generally stable, but we need to make sure it's safe for you to take part.

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 a planned heart angiogram or stent fitting?
Are you able and willing to attend follow-up visits?
Have you had an emergency heart procedure recently (e.g., severe heart attack)? (If yes, you may not be eligible)
Are you currently on dialysis for kidney failure? (If yes, you may not be eligible)
Do you have very severe heart valve issues or very weak heart pumping (LVEF less than 30%)? (If yes, you may not be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to join the study, you'll be randomly assigned to one of two groups, like flipping a coin. You won't know which group you're in, and neither will your doctors, to keep the results fair. Both groups will receive a standard salt solution through a drip before your heart procedure.

During your procedure, even before the planned heart procedure, a small tube will be used to measure the pressure in your heart, which is a routine part of this type of care. Depending on which group you're in, the amount of fluid you get through your drip will either be adjusted specially for you based on this heart pressure, the amount of dye used, and your kidney function. Or you'll receive a standard, fixed amount of fluid. This will continue for a few hours after your procedure.

After your heart procedure, we'll take blood tests to check your kidney function at about 2 days, 7 days, and then again at 6 months.

Potential risks and benefits

Participating in this study might offer the benefit of potentially better protection for your kidneys during your heart procedure with the new personalised fluid strategy, although we don't know for sure if it's more effective than standard care yet. There are no known additional risks to participating beyond those of your standard heart procedure and routine blood tests, as both fluid strategies use a commonly used salt solution. You are completely free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Montreal Heart Institute
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is an angiogram or stent fitting?

These are heart procedures where doctors look at your heart's blood vessels or unblock them, often using a special dye.

What is 'contrast dye'?

It's a special liquid used in procedures like angiograms to make your blood vessels show up clearly on X-rays.

What does a 'personalised hydration strategy' mean?

It means the amount of fluid you get through a drip during and after your procedure will be adjusted specifically for you, based on your heart and kidney health.

Will I know if I'm getting the new treatment?

No, you won't know, and neither will your doctors. This is important so the study results are unbiased and reliable.

What happens if I change my mind?

You can leave the study at any time, and it won't affect the medical care you receive.

How to find out more

Guillaume Marquis-Gravel, MD, MSc

guillaume.marquis.gravel@umontreal.ca (514) 376-3330 Official trial record

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