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Study on the Effects of Custodiol and Buckberg Cardioplegia in Patients Undergoing Major Heart Surgery with Prolonged Aortic Clamping

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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 major cardiac surgery that requires the use of a heart-lung machine, known as extracorporeal circulation. The study aims to evaluate the effects of two different solutions used to protect the heart during surgery, called cardioplegia. The two solutions being compared are CUSTODIOL® and Cardi-Braun Mantenimiento. These solutions contain various substances, such as mannitol, tryptophan, magnesium chloride, and glucose, which help in maintaining the heart's condition during the procedure.

The purpose of the study is to determine if CUSTODIOL® is not inferior to another type of cardioplegia known as Buckberg blood cardioplegia. Patients will receive either CUSTODIOL® or Cardi-Braun Mantenimiento during their surgery. The study will monitor the patients for 90 days after the surgery to observe any major health events, such as heart attacks, kidney failure, or the need for medications to support heart function. Additionally, the study will look at other factors like the need for blood transfusions, the duration of mechanical ventilation, and any neurological complications.

Participants in the study will be closely monitored for any changes in their health, including the levels of a heart-related protein called Troponin I at 12 and 24 hours after surgery. The study will also compare the overall survival rates and the occurrence of conditions like atrial fibrillation, which is an irregular heartbeat, within 90 days post-surgery. This research aims to provide valuable insights into the best practices for protecting the heart during major cardiac surgeries.

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 study

    Upon joining the study, eligibility is confirmed. Participants must be over 18 years old and require major cardiac surgery with extracorporeal circulation and aortic clamping.

  2. Step 2

    Pre-surgery preparation

    Before surgery, participants receive detailed information about the procedure and the types of cardioplegia solutions used: Custodiol and Buckberg.

    Custodiol is a crystalloid solution, while Buckberg is a blood-based solution. Both are used to protect the heart during surgery.

  3. Step 3

    Surgery and cardioplegia administration

    During surgery, one of the cardioplegia solutions is administered through antegrade epicardial coronary artery infusion. This helps to stop the heart safely and protect it during the procedure.

  4. Step 4

    Post-surgery monitoring

    After surgery, participants are monitored for various outcomes, including heart function and kidney health.

    Troponin I levels are checked at 12 and 24 hours to assess heart muscle damage.

    Other monitored outcomes include the need for ionotropic drugs, kidney function, and any bleeding events.

  5. Step 5

    Follow-up period

    Participants are followed for 90 days post-surgery to evaluate overall survival and any complications such as atrial fibrillation or neurological issues.

    The study aims to compare the effectiveness and safety of the two cardioplegia solutions over this period.

Who can join the trial?

5 criteria

  • Patients must be **over 18 years of age**.
  • Patients must have a **heart condition** that requires major heart surgery.
  • The surgery must involve **extracorporeal circulation**, which means using a machine to take over the function of the heart and lungs during the operation.
  • The surgery must also involve **aortic clamping**, which is a procedure where the main artery from the heart is temporarily closed off.
  • Both **men and women** can participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who have had previous cardiovascular surgery. This means any surgery related to the heart or blood vessels.
  • Patients who are not within the specified age range for the study. The study is only for certain age groups.
  • Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care.
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Investigated drugs

  • Custodiol

    is a type of crystalloid cardioplegia solution used to protect the heart during major cardiac surgery. It helps to stop the heart and preserve its function while the surgery is being performed. This solution is designed to provide a protective environment for the heart muscle during periods when blood flow is temporarily stopped.

  • Buckberg

    is a blood cardioplegia solution used during major cardiac surgery. It involves using the patient's own blood mixed with other substances to protect the heart while it is stopped during surgery. This method aims to maintain the heart's health and function by providing nutrients and oxygen even when the heart is not beating.

What is already known about the treatment

  • Custodiol

    Custodiol is administered as a crystalloid solution used in cardioplegia, which is a method to protect the heart during major cardiac surgery. It is currently being evaluated in clinical trials to determine its effectiveness compared to other cardioplegia solutions. The main therapeutic indication for Custodiol is to provide cardiac protection during surgeries involving extracorporeal circulation. At the molecular level, it works by inducing cardiac arrest, thereby reducing the metabolic demands of the heart and protecting it from damage during surgery. Custodiol is classified as a cardioplegic solution.

  • Buckberg

    Buckberg is administered as a blood-based cardioplegia solution, used to protect the heart during major cardiac surgeries. It is being compared in clinical trials to other cardioplegia solutions to assess its effectiveness. The primary therapeutic use of Buckberg is to maintain heart protection during surgeries that require extracorporeal circulation. Its mechanism of action involves delivering oxygenated blood to the heart, which helps in maintaining myocardial function and reducing ischemic damage. Buckberg is classified as a blood cardioplegic solution.

Investigated diseases

  • Acute Myocardial Infarction (AMI)

    This condition occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. It often results from a blockage in one or more of the coronary arteries. Symptoms may include chest pain, shortness of breath, and discomfort in the upper body. The progression can lead to heart muscle damage, affecting the heart's ability to pump blood effectively. Over time, this can result in complications such as heart failure or arrhythmias. Immediate medical attention is crucial to minimize heart damage.

  • Acute Kidney Injury (AKI)

    This condition is characterized by a sudden decrease in kidney function, leading to the accumulation of waste products in the blood. It can occur due to various factors, including reduced blood flow to the kidneys, direct damage to the kidneys, or obstruction of urine flow. Symptoms may include decreased urine output, swelling, and fatigue. The progression can lead to severe fluid and electrolyte imbalances. If not addressed, it may result in long-term kidney damage or chronic kidney disease. Early detection and management are essential to prevent further complications.

  • Atrial Fibrillation

    This is a common type of irregular heartbeat that can lead to blood clots, stroke, heart failure, and other heart-related complications. It occurs when the heart's upper chambers beat irregularly and out of coordination with the lower chambers. Symptoms may include palpitations, weakness, and shortness of breath. The condition can be intermittent or persistent, affecting the heart's efficiency. Over time, it may lead to a weakening of the heart muscle. Management focuses on controlling the heart rate and reducing the risk of stroke.

  • Postoperative Low Cardiac Output Syndrome

    This condition occurs when the heart fails to pump enough blood to meet the body's needs after surgery. It is often seen after cardiac surgery and can result from various factors, including heart muscle damage or inadequate heart function. Symptoms may include fatigue, low blood pressure, and reduced urine output. The progression can lead to organ dysfunction if not managed promptly. Monitoring and supportive care are crucial to stabilize the patient's condition.

  • Neurological Complications

    These complications can arise after surgery and may include issues such as stroke, confusion, or cognitive dysfunction. They occur due to factors like reduced blood flow to the brain or embolism. Symptoms can vary widely, from mild confusion to severe neurological deficits. The progression depends on the underlying cause and severity of the complication. Early recognition and intervention are important to minimize long-term effects.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511948-42-00Protocol codeCARDIO-HEARTEstimated enrolment600 patientsSponsorHospital Clinico San Carlos

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