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New heart solution tested in Kids' surgery: could it be safer?

NCT ID NCT07381530

First seen Feb 02, 2026 · Last updated Jun 22, 2026 · Updated 17 times

Summary

This study compares two solutions, Custodiol and Custodiol-N, used to protect the heart during surgery in children with congenital heart defects. About 100 children will be randomly assigned to receive one of the two solutions. The goal is to see which one is safer and better at preventing heart damage.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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 and Custodiol (heart-protecting solutions used during surgery)

What this could lead to

If Custodiol-N proves safer or more protective, it could become the preferred solution for children undergoing heart surgery, potentially reducing complications.

What could go wrong

This is a phase II trial with only 100 participants, and it is currently suspended. Results may not confirm superiority, and the study may not be completed.

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.