Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children

A Prospective Randomized, Single-blind, Multicenter Phase II Study Comparing Two Methods of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children: Custodiol-N Versus Custodiol

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)

Study Overview

• Status: Suspended
• Conditions: Congenital Heart Malformations
• Intervention / Treatment: Drug: heart will be treated with Custodiol-N; Drug: heart will be treated with Custodiol

Detailed Description

Efficacy of Custodiol-N and its safety is being thoroughly studied in adults undergoing solid organ transplantation. In addition, safety data are available from its use as cardioplegic solution in approximately 400 adults. Paediatric cardiac surgery nearly exclusively addresses congenital heart disease (CHD). CHD comprises a wide variety of congenital malformations of structures of the heart or the great vessels. The causes may be genetic, environmental or both. 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Giessen, Germany, 35385
    • Universitätsklinikum Gießen und Marburg GmbH, Abteilung für Kinderherzchirurgie und angeborene Herzfehler
  • München, Germany, 80636
    • Deutsches Herzzentrum München, TUM Universitätsklinikum, Klinik für Chirurgie angeborener Herzfehler und Kinderherzchirurgie
  • Münster, Germany, 48149
    • Universitätsklinikum Münster, Klinik für Herz- und Thoraxchirurgie,Sektion Kinderherzchirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Custodiol-N; organ will be perfused with Custodiol-N solution	Drug: heart will be treated with Custodiol-N; cardioplegia solution will be administered with perfusion
Active Comparator: Custodiol; organ will be perfused with Custodiol solution	Drug: heart will be treated with Custodiol; cardioplegia solution will be administered with perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of hemodynamics	Vital signs (blood pressure (mmHg))	day 7 postoperatively
Description of hemodynamics	Vital signs (heart rate (bpm))	day 7 postoperatively
Description of hemodynamics	Vital signs (body temperature (°C))	day 7 postoperatively
Description of hemodynamics	Vasopressor/ Catecholamine/ Vasodilator (incl. Milrinone)/ Levosimendan intake (yes/no by timepoint and amount (μg/kg/min))	day 7 postoperatively
Description of hemodynamics	Nitric oxide ventilation (yes/no by timepoint)	day 7 postoperatively
Description of hemodynamics	Extracorporeal membrane oxygenation (ECMO) support (yes/no by timepoint)	day 7 postoperatively
Description of hemodynamics	Need for placement of a permanent Medical Circulatory Support (MCS) (left ventricular assist device (LVAD), right ventricular assist device (RVAD), biventricular assist support (BiVAD)), (yes/no by timepoint)	30 days postoperatively
Description of hemodynamics	Need for heart transplant (yes/no by timepoint)	30 days postoperatively
Description of echo	Systemic-ventricular function (good, moderately impaired, severely impaired)	Baseline, after skin closure and day 7 postoperatively
Description of cardiac injury	Creatine kinase (CK (U/l))	at baseline until postoperative day 2 and postoperative day 7 or discharge
Description of cardiac injury	Troponin T (ng/ml)	at baseline until postoperative day 2 and postoperative day 7 or discharge
Description of hospitals stay/ death	Death (date)	30 days postoperatively
Description of hospitals stay/ death	readmission (to hospital or intensive care), (yes/no and number)	30 days postoperatively
Description of hospitals stay/ death	Length of ICU stay (start and end date)	30 days postoperatively
Description of hospitals stay/ death	Length of hospital stay (start and end date)	30 days postoperatively
Description of surgery	Aortic cross clamping time (min)	during surgery
Description of surgery	Incision-to-closure-time (min)	during surgery
Description of surgery	Reperfusion time (min)	during surgery
Description of surgery	Number of intraoperative administrations of cardioplegia	during surgery
Description of surgery	Total administration duration (min)	during surgery
Description of surgery	Total administration amount (ml)	during surgery
Description of 12-Lead-ECG	Shift in 12-Lead-ECG (ECG QT Interval)	baseline and day 1 postoperatively (Intensive Care Unit)
Description of cardiac arrhythmias	Current heart rhythm (Sinus rhythm, atrioventricular block (AV-Block °I), AV-Block °II, AV-Block °III, Ectopic atrial rhythm with intact AV conduction, other tachycardiac arrhythmia)	until day 7 postoperatively
Description of cardiac arrhythmias	Tachyarrhythmic event since last visit (JET/atrial fibrillation/atrial flutter/ ventricular arrhythmia)	until day 7 postoperatively
Description of cardiac arrhythmias	Need for antiarrhythmic therapy other than beta blockers after end of aortic cross-clamping since last visit (e.g. Adenosine, Amiodarone, Flecainid), (yes/no)	until day 7 postoperatively
Description of cardiac arrhythmias	Current cardiac pacing (none/atrial/ventricular/sequential)	30 days postoperatively

Collaborators and Investigators

• Sponsor: Dr. F. Köhler Chemie GmbH
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Custodiol-N solution
• Other Study ID Numbers: CL-N-CP-Paed-II/09/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No