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Study on Dexamethasone and Olanzapine for Patients Undergoing Heart Surgery

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What is this trial about?

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

This clinical trial is focused on patients undergoing heart surgery, specifically those having procedures like coronary artery bypass grafting or heart valve replacement. The study aims to explore the effectiveness of two medications, dexamethasone and olanzapine, in improving recovery outcomes. Dexamethasone is a type of steroid that can help reduce inflammation, while olanzapine is typically used to treat mental health conditions but is being tested here for its potential benefits in surgery recovery.

The purpose of the study is to see if these medications can help reduce the risk of complications, shorten the length of hospital stay, and improve overall recovery after heart surgery. Participants will receive either the medication or a placebo, which looks like the medication but does not contain any active ingredients. The study will also look at different ways to manage blood flow and breathing during surgery to see if these methods can further improve recovery.

Throughout the study, participants will be monitored for up to 90 days after their surgery to track their recovery progress. The main focus will be on how many days they are alive and outside the hospital during this period. The study will also look at other important outcomes, such as survival rates, the occurrence of complications like stroke or kidney injury, and overall quality of life after surgery. This research aims to find the best ways to support patients' recovery and improve their health outcomes after heart surgery.

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

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide consent to participate in the trial.

  2. Step 2

    Preoperative medication

    Before your heart surgery, you will receive a medication called olanzapine or a placebo. Olanzapine is given as a 20 mg orodispersible tablet, which means it dissolves in your mouth. This medication is taken orally.

  3. Step 3

    Surgery and treatment

    During your heart surgery, you may receive a medication called dexamethasone or a placebo. Dexamethasone is administered through an injection into your vein (intravenous use).

    The surgery will involve either coronary artery bypass grafting (CABG) or aortic valve replacement (AVR), or both, depending on your condition.

  4. Step 4

    Postoperative care

    After the surgery, your recovery will be monitored closely. The trial aims to assess the number of days you are alive and outside the hospital within 90 days after surgery.

    You will be evaluated for any complications, such as stroke, kidney injury, or heart failure, and your recovery quality will be assessed using specific scoring methods.

  5. Step 5

    Follow-up assessments

    You will have follow-up assessments to monitor your health and recovery. These assessments will include checking for any severe complications and evaluating your quality of life and functional status.

    The trial will also track your survival and health outcomes at 90 days and 180 days after surgery.

Who can join the trial?

2 criteria

  • Must be an adult, which means you need to be over 18 years old.
  • Must be scheduled for heart surgery, specifically for coronary artery bypass grafting (CABG) or aortic valve replacement (AVR). It doesn't matter if you are having other valve surgeries at the same time.

Who cannot join the trial?

3 criteria

  • Patients who are not undergoing heart surgery, such as **coronary artery bypass grafting** (a surgery to improve blood flow to the heart) or **heart valve replacement** (a surgery to replace a damaged heart valve), cannot participate.
  • Patients who are not adults, meaning they are not within the age range specified for the study, cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

Dexamethasone is a medication that helps reduce inflammation in the body. In this trial, it is being used to see if it can help patients recover more quickly after heart surgery by reducing the time they need to stay in the hospital.

Olanzapine is a medication that is usually used to treat mental health conditions like schizophrenia and bipolar disorder. In this trial, it is being given to patients before their heart surgery to see if it can help improve their recovery and reduce the time they need to stay in the hospital.

Flow-targeted hemodynamic management is a method used during heart surgery to ensure that blood flow is maintained at an optimal level. This approach focuses on adjusting the flow of blood to meet the body's needs during surgery, which may help improve recovery and reduce hospital stay.

Pressure-targeted hemodynamic management is another method used during heart surgery, but instead of focusing on blood flow, it focuses on maintaining the right blood pressure. This approach aims to ensure that the heart and other organs receive enough blood during surgery, potentially improving recovery and reducing the time spent in the hospital.

Low tidal volume ventilation is a technique used during surgery to help patients breathe. It involves using smaller breaths to protect the lungs while the patient is on a heart-lung machine. This method is being tested to see if it can help patients recover faster and spend less time in the hospital after surgery.

What is already known about the treatment

  • Dexamethasone

    Dexamethasone is administered as an injection or orally in tablet form. It is currently being studied for its effectiveness in reducing mortality and organ damage in patients undergoing heart surgery, such as coronary artery bypass grafting or heart valve replacement. The main therapeutic use of dexamethasone is to reduce inflammation and suppress the immune system. At the molecular level, it works by binding to glucocorticoid receptors, which then influence the expression of specific genes to reduce inflammation. Dexamethasone is classified as a corticosteroid.

  • Olanzapine

    Olanzapine is typically administered orally in tablet form. In the context of this trial, it is being evaluated for its potential to improve outcomes in patients undergoing heart surgery by reducing hospital stay duration. Olanzapine is primarily used to treat mental health conditions like schizophrenia and bipolar disorder. It works by affecting the activity of neurotransmitters in the brain, particularly dopamine and serotonin, to help stabilize mood and behavior. Olanzapine is classified as an atypical antipsychotic.

Investigated diseases

  • Coronary Artery Disease

    This condition involves the narrowing or blockage of the coronary arteries, usually caused by atherosclerosis, which is the buildup of cholesterol and fatty deposits on the artery walls. As the arteries narrow, blood flow to the heart muscle is reduced, which can lead to chest pain, known as angina. If a coronary artery becomes completely blocked, it can result in a heart attack. Over time, coronary artery disease can weaken the heart muscle and contribute to heart failure or arrhythmias. The progression of this disease can vary, with some individuals experiencing rapid worsening of symptoms, while others may have a more gradual progression.

  • Aortic Valve Stenosis

    This disease is characterized by the narrowing of the aortic valve opening, which restricts blood flow from the left ventricle to the aorta and onward to the rest of the body. The heart must work harder to pump blood through the narrowed valve, which can lead to symptoms such as chest pain, fatigue, and shortness of breath. Over time, the increased workload can cause the heart muscle to thicken and weaken. If left untreated, aortic valve stenosis can lead to serious complications, including heart failure. The progression of this condition can vary, with some individuals experiencing rapid symptom onset, while others may have a slower progression.

  • Heart Failure

    This condition occurs when the heart is unable to pump blood effectively to meet the body's needs. It can result from various underlying conditions, such as coronary artery disease, high blood pressure, or previous heart attacks. Symptoms often include shortness of breath, fatigue, and fluid retention, leading to swelling in the legs and abdomen. Heart failure can progress over time, with symptoms worsening as the heart's ability to pump blood diminishes. The progression can be influenced by lifestyle factors and the management of underlying conditions.

  • Stroke

    A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can happen due to a blocked artery (ischemic stroke) or a leaking or bursting blood vessel (hemorrhagic stroke). Without prompt treatment, brain cells begin to die, leading to potential loss of function in the affected area. The progression of a stroke can be rapid, with symptoms such as sudden numbness, confusion, or difficulty speaking appearing quickly. The extent of recovery and progression can vary widely depending on the severity and location of the stroke.

  • Acute Kidney Injury

    This condition is characterized by a sudden decrease in kidney function, leading to the accumulation of waste products in the blood. It can result from various causes, including reduced blood flow to the kidneys, direct damage to the kidneys, or obstruction of urine flow. Symptoms may include decreased urine output, fluid retention, and confusion. The progression of acute kidney injury can be rapid, and the condition may resolve with treatment or progress to chronic kidney disease. The severity and progression depend on the underlying cause and the timeliness of intervention.

  • Delirium

    Delirium is a sudden change in mental status, characterized by confusion, disorientation, and difficulty focusing attention. It can occur due to various factors, including surgery, infection, or medication changes. The condition often develops quickly and can fluctuate throughout the day. Delirium can lead to longer hospital stays and increased risk of complications if not addressed. The progression of delirium can vary, with some individuals experiencing rapid improvement, while others may have persistent symptoms.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515998-94-00Protocol code2021-HJEPharma-002Estimated enrolment1 200 patientsSponsorRegion Hovedstaden

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