NCT07381530

Brief Summary

The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation. All endpoint timings refer to the opening of the aortic cross clamp (t=0)

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Dec 2024

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Dec 2024Dec 2027

First Submitted

Initial submission to the registry

October 28, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 5, 2024

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

October 28, 2024

Last Update Submit

February 5, 2026

Conditions

Congenital Heart Malformations

Outcome Measures

Primary Outcomes (2)

  • safety assessment

    Continuous adverse events (AEs) reporting

    AEs up to 30 days postoperatively

  • safety assessment

    Myocardial protection in surviving patients assessed by quantification of perioperative CK-MB levels (U/l)

    CK-MB (Creatinkinase-MB) levels at baseline until postoperative day 2 and postoperative day 7 or discharge

Secondary Outcomes (26)

  • Description of hemodynamics

    day 7 postoperatively

  • Description of hemodynamics

    day 7 postoperatively

  • Description of hemodynamics

    day 7 postoperatively

  • Description of hemodynamics

    day 7 postoperatively

  • Description of hemodynamics

    day 7 postoperatively

  • +21 more secondary outcomes

Study Arms (2)

Custodiol-N

EXPERIMENTAL

organ will be perfused with Custodiol-N solution

Drug: heart will be treated with Custodiol-N

Custodiol

ACTIVE COMPARATOR

organ will be perfused with Custodiol solution

Drug: heart will be treated with Custodiol

Interventions

heart will be treated with Custodiol-NDRUG

cardioplegia solution will be administered with perfusion

Custodiol-N
heart will be treated with CustodiolDRUG

cardioplegia solution will be administered with perfusion

Custodiol

Eligibility Criteria

Age24 Hours - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Giessen, 35385, Germany

Location

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

München, 80636, Germany

Location

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

Münster, 48149, Germany

Location

MeSH Terms

Interventions

Custodiol-N solution

Study Officials

  • Philippe Grieshaber, PD Dr.

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

    PRINCIPAL INVESTIGATOR

  • Christine-Elena Kamla, Dr.

    Deutsches Herzzentrum München, TUM Universitätsklinikum, Germany

    PRINCIPAL INVESTIGATOR

  • Mohamed Salem, Dr.

    Kinderherzzentrum, Universitätsklinikum Gießen und Marburg GmbH, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patient and their legal representatives will be blinded to treatment. All other parties are unblinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2024

First Posted

February 2, 2026

Study Start

December 5, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)