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New heart solution tested in Kids' surgery: could it offer better protection?

NCT ID NCT07381530

Disease control Sponsor: Dr. F. Köhler Chemie GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two solutions, Custodiol and Custodiol-N, used to protect the heart during surgery for children with congenital heart defects. About 100 children will receive one of the two solutions while on a heart-lung machine. The goal is to see which one is safer and better at preventing heart damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Custodiol-N (a cardioplegia solution)
What this could lead to
If Custodiol-N proves safer or more protective, it could become a preferred option to protect children's hearts during surgery for birth defects.
What could go wrong
This is a small, early-phase trial that is currently suspended, so results may be delayed or never completed. The study compares two similar solutions, so a major breakthrough is unlikely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

24 hours to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age from birth to less than 18 years of age * congenital heart surgery with cardiopulmonary bypass and cardioplegia * written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study) * Ability of the legal guardians to understand character and individual consequences of the clinical trial Exclusion Criteria: * Patients who have participated within 30 days or are still participating in any other interventional study * History of severe organic (e.g. liver or kidney) disease other than concerning the heart * History of psychiatric disease * Pregnancy and lactation

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Conditions

The condition(s) this trial relates to.

congenital heart malformation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital heart malformations

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Deutsches Herzzentrum München, TUM Universitätsklinikum, Klinik für Chirurgie angeborener Herzfehler und Kinderherzchirurgie

    München, 80636, Germany

  • Universitätsklinikum Gießen und Marburg GmbH, Abteilung für Kinderherzchirurgie und angeborene Herzfehler

    Giessen, 35385, Germany

  • Universitätsklinikum Münster, Klinik für Herz- und Thoraxchirurgie,Sektion Kinderherzchirurgie

    Münster, 48149, Germany

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