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Study Comparing Custodiol-N and Custodiol for Heart Surgery in Children with Congenital Heart Defects

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on children with congenital heart malformation who need heart surgery. During the operation a technique called cardioplegia is used, which temporarily stops the heart so surgeons can work safely. Two different heart‑protecting solutions are being compared: the standard solution known as Custodiol® and a newer formulation called Custodiol‑N. Both solutions are given by infusion, meaning they are slowly delivered into the blood to keep the heart tissue safe while it is stopped.

The main purpose of the trial is to assess safety and how well the heart is protected, using measurements such as the enzyme CK‑MB, which rises when heart muscle cells are injured. Children are randomly assigned to receive either the standard or the new solution during their surgery. After the operation they are observed for up to 30 days, with regular checks of vital signs, blood tests, and heart monitoring to record any problems or side effects. The study follows each child through the hospital stay and a short recovery period to gather the needed information.

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

    Enrollment

    Eligibility is determined based on age (from birth to less than 18 years) and the need for congenital heart surgery with cardiopulmonary bypass and cardioplegia.

    Written informed consent from the patient or their legal guardians is required before joining the study.

  2. Step 2

    Pre-surgery preparation

    The patient is prepared for surgery, which involves the use of cardioplegia solutions: Custodiol-N or Custodiol.

    These solutions are administered through infiltration to protect the heart during surgery.

  3. Step 3

    Surgery

    The surgery is performed to correct congenital heart malformations.

    During the procedure, the chosen cardioplegia solution is used to protect the heart.

  4. Step 4

    Post-surgery monitoring

    Continuous monitoring for adverse events is conducted for up to 30 days after surgery.

    Heart protection is assessed by measuring CK-MB levels, a marker of heart muscle injury, until 7 days after surgery.

  5. Step 5

    Follow-up assessments

    Various assessments are conducted, including hemodynamics, echo, and cardiac injury markers like creatinine kinase and troponin.

    The duration of hospital and ICU stay, as well as any readmissions or deaths, are recorded.

    Additional evaluations include 12-lead ECG and monitoring for cardiac arrhythmias, including the need for a pacemaker.

Who can join the trial?

5 criteria

  • The patient must be from birth to less than 18 years old.
  • The patient must have undergone congenital heart surgery. This is a type of surgery to fix heart problems that are present from birth.
  • The surgery must include cardiopulmonary bypass and cardioplegia. Cardiopulmonary bypass is a technique that temporarily takes over the function of the heart and lungs during surgery. Cardioplegia is a method used to protect the heart during surgery by stopping it from beating.
  • There must be a written informed consent from the patient and/or their legal guardians. This means they must agree to participate in the study after being fully informed about it.
  • The legal guardians must be able to understand the nature and individual consequences of the clinical trial. This means they need to understand what the study involves and how it might affect the patient.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had a recent surgery or medical procedure that might affect the study results.
  • Patients who are currently participating in another clinical trial.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients with allergies or reactions to any of the study medications or treatments.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse.
  • Patients with certain infections that could impact the study.
  • Patients who have received certain medications that could interfere with the study.
  • Patients with a history of certain heart conditions that are not related to the study.
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Investigated drugs

  • Custodiol-N

    is a solution used during heart surgery to protect the heart muscle. It helps to stop the heart safely and preserve its function while the surgery is being performed. This solution is specifically designed to be used in children undergoing surgery for congenital heart defects.

  • Custodiol

    is another type of solution used in heart surgery for myocardial protection. Like Custodiol-N, it is used to stop the heart and protect it during surgery. This solution is also used in pediatric patients with congenital heart malformations.

What is already known about the treatment

  • Custodiol-N

    This medication is administered intravenously during cardiac surgery to protect the heart muscle. It is currently being studied in clinical trials for its effectiveness in surgeries for congenital heart malformations in children. The main therapeutic indication is to provide myocardial protection during surgery. At the molecular level, it works by preserving the energy stores of heart cells and reducing metabolic activity, which helps protect the heart tissue during periods of reduced blood flow. It is classified as a cardioplegic solution, which is used to induce cardiac arrest and protect the heart during surgery.

  • Custodiol

    This medication is also administered intravenously during cardiac surgery and is being compared to Custodiol-N in clinical trials for congenital heart malformations in children. Its primary use is to protect the heart muscle during surgery. The mechanism of action involves reducing the heart's metabolic demands and preserving cellular energy, which helps maintain heart tissue viability during surgery. Like Custodiol-N, it is classified as a cardioplegic solution, used to safely stop the heart and protect it during surgical procedures.

Investigated diseases

Congenital Heart Malformation in Children – This condition involves structural abnormalities of the heart present at birth. These malformations can affect the heart's walls, valves, or blood vessels, impacting how blood flows through the heart and to the rest of the body. The progression of the disease varies widely depending on the type and severity of the malformation. Some children may experience symptoms such as difficulty breathing, poor feeding, or delayed growth. In some cases, the condition may remain stable, while in others, it may lead to complications that require medical intervention. Regular monitoring and assessment are often necessary to manage the condition effectively.
Trial detailsLast updated 21 Oct 2026
Age0-17PhasePhase IITrial ID2024-511517-38-00Protocol codeCL-N-CP-PaedEstimated enrolment100 patientsSponsorDr. Franz Koehler Chemie GmbH

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