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Study Comparing Buckberg and Del Nido Solutions for Heart Surgery in Patients with Cardiovascular Disease

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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 studying the effects of two different heart protection solutions, known as cardioplegia, during heart surgery. The study involves patients undergoing a specific type of heart surgery called myocardial revascularization, which is a procedure to improve blood flow to the heart. The two solutions being compared are called Buckberg cardioplegia and Del Nido cardioplegia. These solutions contain a mix of substances, including calcium chloride, potassium chloride, sodium chloride, and magnesium chloride, which help protect the heart during surgery.

The purpose of the study is to determine which of these two solutions is more effective and safe in protecting the heart during surgery. The study will look at how well each solution protects the heart by measuring certain markers in the blood that indicate heart injury, such as CK and Troponin T. It will also track the number of patients who survive the surgery and their hospital stay. The study will follow patients for a short period after their surgery to gather this information.

Participants in the study will receive either the Buckberg or Del Nido solution during their surgery. The study will monitor various aspects of their recovery, including the time it takes for their heart to start beating on its own again, the need for medications to support heart function, and any complications that may arise. The goal is to gather data that will help doctors choose the best method for protecting the heart during this type of surgery in the future.

The research process

The trial runs in 6 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 based on criteria such as age, type of surgery, and consent.

    The study involves patients undergoing isolated myocardial revascularization surgery with extracorporeal circulation.

  2. Step 2

    Surgery preparation

    Before surgery, preparation includes standard preoperative procedures and assessments.

    The surgery involves the use of cardioplegia solutions, which are special fluids used to protect the heart during surgery.

  3. Step 3

    Surgery and cardioplegia administration

    During surgery, one of two cardioplegia solutions, Buckberg or Del Nido, is administered to protect the heart.

    The solutions contain substances like calcium chloride, potassium chloride, sodium chloride, and magnesium chloride, delivered directly to the heart.

  4. Step 4

    Postoperative monitoring

    After surgery, monitoring includes checking levels of heart injury markers such as CK and Troponin T for the first 5 days.

    Other factors monitored include heart rhythm recovery, need for defibrillation, and use of medications to support heart function.

  5. Step 5

    Recovery and follow-up

    Recovery involves monitoring in the ICU, with attention to factors like blood glucose, hemoglobin levels, and potential need for blood transfusions.

    Follow-up includes assessments of heart function through echocardiography and possibly cardiac resonance imaging.

  6. Step 6

    Discharge and final assessments

    Discharge occurs after a period of recovery, with total hospitalization days recorded.

    Final assessments include evaluation of heart function and any complications such as atrial fibrillation or myocardial infarction.

Who can join the trial?

4 criteria

  • Patients must be of legal age, which means they need to be older than 18 years.
  • Both men and women can participate in the study.
  • Patients must be undergoing a specific type of heart surgery called isolated myocardial revascularization surgery, which involves improving blood flow to the heart, using a method called extracorporeal circulation. This is a technique where a machine temporarily takes over the function of the heart and lungs during surgery.
  • Patients must agree to participate by providing their informed consent, which means they understand the study and agree to be part of it.

Who cannot join the trial?

5 criteria

  • Patients with any other serious heart conditions besides the one being studied.
  • Patients who are not undergoing the specific heart surgery mentioned in the study.
  • Patients who are not using the heart-lung machine during their surgery.
  • Patients who are not receiving one of the two specific heart protection solutions being compared in the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Buckberg Cardioplegia

    is a solution used during heart surgery to protect the heart muscle. It helps to stop the heart and keep it safe while the surgeon works on it. This solution is designed to reduce damage to the heart muscle during surgery by providing nutrients and oxygen.

  • Del Nido Cardioplegia

    is another type of solution used in heart surgeries to protect the heart. Like Buckberg, it helps to stop the heart and protect it during the operation. Del Nido is known for its ability to keep the heart safe for a longer period, which can be beneficial in certain types of heart surgeries.

What is already known about the treatment

  • Buckberg Cardioplegia

    This medication is administered intravenously during heart surgery to protect the heart muscle. It is currently used in clinical settings and is being studied for its effectiveness and safety in myocardial revascularization surgery. The main therapeutic indication is to provide myocardial protection during cardiac surgery. At the molecular level, it works by temporarily stopping the heart and reducing its metabolic needs, allowing surgeons to operate on a still heart. It is classified as a cardioplegic solution.

  • Del Nido Cardioplegia

    This medication is also administered intravenously during heart surgery to protect the heart muscle. It is widely used in clinical practice and is being evaluated for its efficacy and safety in myocardial revascularization surgery. The primary therapeutic use is to protect the heart during surgery by stopping it and reducing its metabolic demands. Its mechanism of action involves inducing cardiac arrest and preserving heart tissue. It belongs to the pharmacological class of cardioplegic solutions.

Investigated diseases

Myocardial Infarction – Myocardial infarction, commonly known as a heart attack, 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. This blockage is often due to a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. The progression of the disease involves the rupture of this plaque, leading to the formation of a blood clot that can completely block the artery. Without quick restoration of blood flow, the affected heart muscle can suffer irreversible damage. Symptoms may include chest pain, shortness of breath, and other discomforts. The severity and progression can vary based on the extent of the blockage and the area of the heart affected.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505855-32-01Protocol codeIIBSP-CAR-2023-74Estimated enrolment286 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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