Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery

NCT03082716 | Completed Phase 2 DMC

• 1 other identifier: IRB 2016-08 Custodiol Study
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial preservation and minimise myocardial swelling ,while providing a motionless and bloodless field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still preferring to use it for myocardial protection of paediatric cardiac surgery ,although it is thought to be more time consuming since it is given with interrupted doses, . Even when advancement has came along the field of myocardial protection and cardioplegia solutions with the introduction of Bretschneider Histidine-Tryptophan-Ketoglutarate solution ,custodiol ,in 1970 ,which is given as a single dose and believed to be convenient, simple to deliver , and less time consuming . Many Surgeons haven't change their practice possibly due to paucity of studies comparing cardioplegia solutions in paediatric cardiac surgery and conflicting reports regarding the superiority of different cardioplegia solution.The investigators aim to provide evidence that will help paediatric cardiac surgeons to choose the optimal solution for their practice .

Conditions

Congenital Heart Disease

Keywords

cardioplegia; myocardial protection; custodiol; htk

Outcome Measures

Primary Outcomes (3)

• Mortality (yes/no)

  Death of all causes

  up to 30 days

• ICU stay (days)

  length of ICU stay

  up to 90 days (length of ICU stay required after the operative procedure recorded by days until discharge or death)

• Arrhythmia (yes/no)

  post operative arrythmia that required intervention

  up to 48 hours

Secondary Outcomes (7)

• length of stay (days)

  up to 90 days (length of the hospital stay required since admission recorded by days until discharge or death )

• length of mechanical ventilation (hours)

  up to 5 days

• myocardial biomarkers

  up to 5 days

• Subjective ventricular function (normal,mildly depressed ,moderately depressed ,moderately-severe depressed ,severly depressed )

  up to 24 hours

• Ejection fraction (percentage)

  up to 24 hours

Study Arms (2)

blood cardioplegia group

ACTIVE COMPARATOR

patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.

Drug: Blood cardioplegia

custodiol group

EXPERIMENTAL

patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.

Drug: Custodiol Solution

Interventions

Custodiol Solution DRUG

After cross clamping patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.

Also known as: htk

custodiol group

Blood cardioplegia DRUG

After cross clamping patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.

blood cardioplegia group

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All paediatric patients referred to our hospital which will undergo open cardiac repair with cardiopulmonary bypass and cardioplegic arrest .

You may not qualify if:

• All emergency procedure( require immediate surgery)
• Cases that don't require use of cardioplegia .

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research Centre

Jeddah, Western, 40047, Saudi Arabia

Location

Related Publications (9)

• Kotani Y, Tweddell J, Gruber P, Pizarro C, Austin EH 3rd, Woods RK, Gruenwald C, Caldarone CA. Current cardioplegia practice in pediatric cardiac surgery: a North American multiinstitutional survey. Ann Thorac Surg. 2013 Sep;96(3):923-9. doi: 10.1016/j.athoracsur.2013.05.052. Epub 2013 Jul 31.

  PMID: 23915588 BACKGROUND

• Harvey B, Shann KG, Fitzgerald D, Mejak B, Likosky DS, Puis L, Baker RA, Groom RC; American Society of ExtraCorporeal Technology's International Consortium for Evidence-Based Perfusion and Pediatric Perfusion Committee. International pediatric perfusion practice: 2011 survey results. J Extra Corpor Technol. 2012 Dec;44(4):186-93.

  PMID: 23441558 BACKGROUND

• Korun O, Ozkan M, Terzi A, Askin G, Sezgin A, Aslamaci S. The comparison of the effects of Bretschneider's histidine-tryptophan-ketoglutarate and conventional crystalloid cardioplegia on pediatric myocardium at tissue level. Artif Organs. 2013 Jan;37(1):76-81. doi: 10.1111/j.1525-1594.2012.01575.x.

  PMID: 23305576 BACKGROUND

• elmorsy et al , Does type of cardioplegia affect myocardial and cerebral outcome in pediatric open cardiac surgeries? Ain-Shams Journal of Anesthesiology ,2014; 2(7) :242-249

  BACKGROUND

• Bojan M, Peperstraete H, Lilot M, Tourneur L, Vouhe P, Pouard P. Cold histidine-tryptophan-ketoglutarate solution and repeated oxygenated warm blood cardioplegia in neonates with arterial switch operation. Ann Thorac Surg. 2013 Apr;95(4):1390-6. doi: 10.1016/j.athoracsur.2012.12.025. Epub 2013 Feb 22.

  PMID: 23462260 RESULT

• Liu J, Feng Z, Zhao J, Li B, Long C. The myocardial protection of HTK cardioplegic solution on the long-term ischemic period in pediatric heart surgery. ASAIO J. 2008 Sep-Oct;54(5):470-3. doi: 10.1097/MAT.0b013e318188b86c.

  PMID: 18812735 RESULT

• Chen Y, Liu J, Li S, Li W, Yan F, Sun P, Wang H, Long C. Which is the better option during neonatal cardiopulmonary bypass: HTK solution or cold blood cardioplegia? ASAIO J. 2013 Jan-Feb;59(1):69-74. doi: 10.1097/MAT.0b013e3182798524.

  PMID: 23263337 RESULT

• Custodiol versus blood cardioplegia in pediatric cardiac surgery. SHAJ .October 2015 ;27,(4):327

  RESULT

• Elmahrouk AF, Shihata MS, Al-Radi OO, Arafat AA, Altowaity M, Alshaikh BA, Galal MN, Bogis AA, Al Omar HY, Assiri WJ, Jamjoom AA. Custodiol versus blood cardioplegia in pediatric cardiac surgery: a randomized controlled trial. Eur J Med Res. 2023 Oct 5;28(1):404. doi: 10.1186/s40001-023-01372-4.

  PMID: 37798628 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Bretschneider cardioplegic solution; Receptor, EphB4

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Receptors, Eph Family; Receptor Protein-Tyrosine Kinases; Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding : Surgeons will know the type of cardioplegia in the OR while other assessor will be blinded .
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomisation : Computer generated randomisation into two groups based on cardioplegia solution . if randomised to blood patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg. if randomised to custodial patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: March 17, 2017
• Study Start: March 16, 2016
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

SA (1)