AuthorisedTherapeutic confirmatory (Phase III)Interventional

Prolonged corticosteroid therapy in scheduled cardiac surgery in intermediate/high-risk patients: a prospective multicenter randomized controlled double-blind placebo-controlled study

This research is investigating if a type of medicine called corticosteroids (specifically hydrocortisone and fludrocortisone) can help patients recover better after major heart surgery. The study focuses on individuals who have a higher chance of developing complications following their operation, such as kidney problems or breathing difficulties. Researchers want to find out if these medicines can reduce complications like acute kidney failure (when kidneys suddenly stop working well), lung issues after surgery, or the need for a particular type of blood pressure support. It's a large study, involving many hospitals, and is carefully designed to compare the medicines against a dummy treatment to ensure the results are reliable. The main goal is to see if these steroids are both helpful and safe.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Enrolment target

196

Start

30 Apr 2025

high /medium risk cardiac surgery acute renal failure

What is this study about?

When people have heart surgery, especially if they have other health conditions, there’s a chance they might experience complications afterwards. These can include kidney problems, breathing difficulties, or needing medication to help keep their blood pressure stable. This study is exploring whether a group of medicines called corticosteroids could help reduce these risks. Corticosteroids are powerful medicines that can reduce inflammation in the body.

The research involves comparing these steroid medicines (hydrocortisone and fludrocortisone) with a placebo – which looks like the real medicine but contains no active drug. This is done to accurately see if the steroids are truly making a difference. Doctors and patients won't know who is getting the active medicine and who is getting the placebo until the end of the study, which helps make the results fairer and more reliable.

The main things the researchers will be looking for are how many people develop sudden kidney failure, lung problems, or require a blood pressure-boosting drug called noradrenaline within the first seven days after surgery. They will also be monitoring for other important outcomes like stroke, other heart problems, and any side effects from the medicines, including infections or changes in sugar and salt levels in the blood. The study also tracks survival rates for 28 days after the operation.

Key takeaways

This study investigates if steroids can reduce heart surgery risks.
It targets patients with higher chances of post-surgery complications.
Researchers are looking out for kidney failure, lung issues, and blood pressure problems.
Participants will receive either study medicine or a dummy treatment.
The study monitors health for up to 28 days after surgery.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged 18 and over, regardless of their gender. Participants will be individuals who are scheduled to have heart surgery and have been identified by their doctors as having a medium to high risk of complications following the procedure.

Specific criteria will be used to see if someone is a good fit for the study. Generally, if you're planning to have heart surgery and your medical team believes you might be at higher risk for certain problems afterwards, you might be considered. The doctors involved in the study will be able to explain the full list of requirements to you.

There might also be reasons why someone cannot join, such as having certain existing medical conditions or taking particular medicines that could interfere with the study treatments. Your doctor will discuss all these details with you carefully.

Quick self-check

Am I 18 years old or older?
Am I scheduled for heart surgery?
Has my doctor told me I'm at medium or high risk for complications?
Am I able to understand and agree to participate?
Do I have any specific medical conditions or take medicines that might prevent my involvement (my doctor will advise)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive either the study medicines (hydrocortisone and fludrocortisone) or a placebo (a dummy medicine) around the time of your heart surgery. This will involve taking tablets or receiving medicine through a drip. During your hospital stay and after, the study team will closely monitor your health. They will check for any signs of kidney failure, lung problems, or other complications. They will also keep an eye on your blood pressure, sugar levels, and salt levels.

Your participation would involve regular checks and assessments by the medical team, similar to the care you would receive anyway, but with extra data collection for the study. This will likely involve blood tests and other routine checks. The total duration of active follow-up for the main goals of the study is typically within the first seven days after surgery, with an overall check on survival up to 28 days.

Potential risks and benefits

Potential benefits of taking part could include receiving a treatment that might help reduce the risk of serious complications like kidney failure or lung problems after heart surgery. However, there's no guarantee the treatment will work for you, and you might receive a placebo. As with all medicines, corticosteroids can have side effects, which the study will carefully monitor, such as increased blood sugar or salt levels, and a higher chance of certain infections. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
France

Common questions

What are corticosteroids?

Corticosteroids are powerful medicines that help reduce inflammation and swelling in the body. They are different from the steroids sometimes used by athletes.

Why is this study 'double-blind'?

Double-blind means that neither you nor your doctor will know if you're receiving the actual medicine or a placebo. This helps make sure the study results are fair and objective.

What is 'acute renal failure'?

Acute renal failure means your kidneys suddenly stop working as well as they should, which can cause waste products to build up in your blood.

What is 'noradrenaline'?

Noradrenaline is a medicine given to help raise and stabilise blood pressure, especially when it drops very low after surgery.

Will I still get my usual care if I join this study?

Yes, you will continue to receive the same high standard of medical care for your heart condition, regardless of whether you choose to participate in the study.