Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery
Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery
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 .
Hypothesis :

 Custodial is not inferior to blood cardioplegia in myocardial protection in paediatric
 cardiac surgery ..

 Methodology :

 Study design :

 Randomized controlled trial

 Data collection:

 All demographic data ,diagnosis ,procedure(type.CPB time ,crossclamp time) , surgeon and
 hospital course details .

 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..

 Blinding :

 Surgeons will know the type of cardioplegia in the OR while other assessor will be blinded .

 Sample size calculated with an online calculator based on α error of 0.05 and β error of 0.2
 to detect an absolute risk difference of 15% in composite end point between the two groups
 yielded 137 in each arm ,The results will be presented as mean (SD), median (interquartile
 range), or proportion . Using relative risk and log rank for statistical analysis .A P value
 of less than 0.05 will be considered statistically significant. Statistical analyses will be
 carried out using the SPSS .

 Safety monitoring and interim results :

 Both cardioplegia solutions are already in use and FDA approved there is no safety concerns
 at the time being . However , an interim analysis will be carried on every 6 months and the
 principal investigator will decide weather to stop or carry on if any major discrepancies in
 outcomes

 literature review : After an extensive literature review the investigators found only one
 randomised trial by elmorsy et al , which concluded that A single dose of an HTK cardioplegic
 solution provides better myocardial and cerebral protection than repeated doses of oxygenated
 blood cardioplegia during pediatric congenital cardiac surgery.

 On the other hand there was another retrospective report by bojan et al, found that The use
 of Custodiol cardioplegia in neonates undergoing ASO was associated with a larger troponin
 release when compared with warm blood cardioplegia,p <0.001 suggesting poor myocardial
 protection.

 koruon et al, done a tissue level comparison between htk and conventional crystalloid
 cardioplegia and their statistical analysis revealed no significant difference between the
 two groups regarding the clinical variables, apoptotic indices and proliferation indices.

 Liu j et al ,did a retrospective study comparing custodiol to St. Thomas crystalloid
 cardioplegia which concluded That HTK group had shorter cross-clamping time and more frequent
 spontaneous defibrillation than St. Thomas group.

 Also an animal study by Chen Y et al, on piglets that were randomised to either a single dose
 of HTK or multidose cold blood cardioplegia .. No significant differences were noted in the
 myocardial lactate content, ATP content, and histopathological score between both groups .

 Finally a retrospective report by E Qulisy et al concluded that Custodiol cardioplegia is
 associated with less myocardial protection and higher adverse outcomes compared to blood
 cardioplegia in pediatric age group undergoing cardiac surgery.
Inclusion Criteria:

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

 Exclusion Criteria:

 -  All emergency procedure( require immediate surgery)

 -  Cases that don't require use of cardioplegia .