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Study of hydrocortisone and fludrocortisone in patients with intermediate/high-risk scheduled cardiac surgery to prevent complications

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients undergoing cardiac surgery who are at intermediate or high risk of complications. The study aims to test if extended treatment with corticosteroid medications can help prevent complications after heart surgery. The main medications being studied are hydrocortisone (given through an infusion into a vein) and fludrocortisone (given as tablets) compared to inactive substances (placebo).

The treatment will last for 5 days and will be given to patients who need heart surgery that uses a heart-lung bypass machine (a device that temporarily takes over the function of the heart and lungs during surgery). The study will look at whether these medications can help prevent several complications that can occur after surgery, including acute renal failure (sudden loss of kidney function), breathing problems, and the need for medications to maintain blood pressure.

Patients will receive either the combination of both medications or inactive substances that look the same as the real medications. The study will monitor patients for various side effects and complications for up to 28 days after their surgery. Some of the things being watched for include problems with salt levels in the blood, high blood sugar, infections, and any effects on the heart or brain.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication administration

    After joining the study and before the scheduled cardiac surgery, you will be randomly assigned to receive either the study medication or placebo

    The treatment involves a combination of hydrocortisone and fludrocortisone, administered for 5 days

  2. Step 2

    Cardiac surgery procedure

    You will undergo the planned cardiac surgery using extracorporeal circulation (a machine that temporarily takes over the function of your heart and lungs during surgery)

    The medical team will monitor your condition throughout the procedure

  3. Step 3

    Post-surgery monitoring - First 7 days

    The medical team will monitor you for signs of acute renal failure (kidney problems)

    Your lung function will be checked for any post-surgery breathing complications

    If needed, you may receive noradrenaline (a medication to maintain blood pressure)

    Your blood sodium and sugar levels will be regularly checked

    You will be monitored for any signs of infection

  4. Step 4

    Extended monitoring period

    Your health status will continue to be monitored for up to 28 days after surgery

    The medical team will check for any heart-related complications

    Brain imaging will be performed if any neurological symptoms occur

  5. Step 5

    Study completion

    The study monitoring period ends 28 days after your surgery

    All collected health data will be used to evaluate the effectiveness of the medication

Who can join the trial?

7 criteria

  • You must be over 18 years old
  • You must be scheduled for planned cardiac surgery (heart operation that is arranged in advance, not emergency)
  • Your surgery must be considered intermediate or high risk with a special risk score (EuroScore II) greater than 4%
  • Your surgery must use extracorporeal circulation (a machine that temporarily takes over the function of the heart and lungs during surgery)
  • You must be able to understand and sign an informed consent form (a document that explains the study and its risks)
  • Both men and women can participate in this study
  • You must be willing to receive either corticosteroid therapy (anti-inflammatory medications) or placebo (inactive substance) for 5 days

Who cannot join the trial?

15 criteria

  • Age under 18 years old
  • Current or recent treatment with corticosteroids (medications that reduce inflammation) within the last 3 months
  • Known allergy to hydrocortisone or fludrocortisone
  • Presence of active infection
  • Emergency cardiac surgery
  • Chronic kidney disease requiring dialysis (a procedure to remove waste from blood when kidneys don't work properly)
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • Having a condition that affects the body's hormone system (endocrine disorder)
  • History of severe mental illness that could affect ability to provide informed consent
  • Life expectancy less than 6 months due to other medical conditions
  • Inability to follow study procedures
  • Immunosuppression (weakened immune system) from any cause
  • Severe liver disease
  • Recent heart attack or stroke (within last 3 months)
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Investigated drugs

Hydrocortisone is a steroid medication that helps reduce inflammation and suppress immune system responses in the body. It's commonly used during and after surgery to help manage stress and inflammation. This medication is a synthetic version of cortisol, a natural hormone produced by your body. Fludrocortisone is another type of steroid medication that helps regulate salt and fluid levels in the body. It works by helping your body retain sodium and excrete potassium. This medication is particularly useful in maintaining stable blood pressure and proper fluid balance during and after surgical procedures. These medications are being studied in combination as a prolonged therapy for patients undergoing planned heart surgery, to see if they can improve outcomes compared to patients who don't receive this treatment.

What is already known about the treatment

  • Hydrocortisone

    A synthetic corticosteroid medication administered either orally, intravenously, or topically, widely used in modern medicine as a primary treatment for various inflammatory conditions. This steroid hormone works by suppressing the immune system and reducing inflammation throughout the body by mimicking the effects of cortisol, a natural hormone produced by the adrenal glands. In cardiac surgery, it helps manage stress response and reduce post-operative complications, particularly in high-risk patients, while also being used to treat conditions such as severe allergic reactions, autoimmune disorders, and adrenal insufficiency.

  • Fludrocortisone

    A synthetic corticosteroid medication taken orally that acts as both a mineralocorticoid and glucocorticoid, primarily used to treat conditions where the body needs additional aldosterone-like effects. This medication works by helping the body retain salt and water while increasing blood pressure, making it particularly valuable in treating conditions such as adrenal insufficiency and orthostatic hypotension. In cardiac surgery settings, when combined with hydrocortisone, it helps maintain proper fluid and electrolyte balance while providing additional anti-inflammatory effects to reduce post-operative complications.

Investigated diseases

  • Acute Renal Failure

    A condition where the kidneys suddenly stop working properly, leading to a build-up of waste products in the blood. It develops over a few hours or days, causing fluid retention and changes in blood chemistry. The condition can affect the body's ability to maintain proper fluid balance and regulate important minerals like sodium and potassium. Common signs include decreased urine output, swelling in legs and ankles, and shortness of breath.

  • Postoperative Pulmonary Complications

    A group of breathing problems that can occur after surgery. These complications can include difficulty breathing, decreased oxygen levels, and accumulation of fluid in the lungs. The condition typically develops within the first few days after surgery and can affect normal breathing patterns.

  • Stroke

    A sudden interruption of blood flow to part of the brain, causing neurological symptoms. It occurs when either a blood vessel becomes blocked or bursts, leading to damage in brain tissue. The condition causes sudden onset of symptoms such as weakness on one side of the body, difficulty speaking, or vision problems. Brain imaging typically shows the affected area of the brain.

  • Mediastinitis

    An inflammation or infection of the tissue in the middle of the chest between the lungs. This condition can develop after chest surgery and affects the area that contains the heart, large blood vessels, windpipe, and other important structures. The infection can cause chest pain, fever, and general discomfort.

  • Hypernatremia

    A condition where there is too much sodium in the blood. It occurs when the body's water and sodium balance is disrupted, leading to sodium levels above normal range. This imbalance can affect how the body's cells function and regulate fluids.

  • Hyperglycemia

    A condition where blood sugar levels become too high. It occurs when the body cannot effectively use or produce insulin to regulate blood glucose. The condition can develop gradually and may require insulin therapy to maintain proper blood sugar levels.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517699-39-00Protocol codePI2024_843_0047Estimated enrolment196 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

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