Pediatric Myocardial Protection With Potassium Cardioplegia

Study Overview
=================
Brief Summary
-----------------
The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of congenital heart disease encourage us to discuss problems that occur during this surgery especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI) as a result of cessation and re-initiation of coronary artery circulation

Detailed Description
-----------------
After approval of the local ethics committee of Assiut University and obtaining written informed consent from parents or guardians of all patients, 60 patients with congenital heart disease will be included. Patients will be randomly allocated into three groups

Official Title
-----------------
Pediatric Myocardial Protection; Large Volume Potassium Cardioplegia Advantageous Over Small Volume Potassium Cardioplegia: Where do we Stand?

Conditions
-----------------
Cardioplegia

Intervention / Treatment
-----------------
* Drug: Cold blood cardioplegia (large volume)
* Drug: Cold blood cardioplegia (small volume)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time>45 minutes. Hemodynamic stability. Exclusion Criteria: Previous cardiac surgery. Urgent or emergent cases. Any known allergies to components of either cardioplegia solutions.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group L<br>Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg The content of cardioplegic solution will be (K+, 10mmol/L) lidocaine 50 mg/L, magnesium sulphate 1 gm/L,dextrose 25% 25 mL/L and sodium bicarbonate 8.4% 25 mL/L during cardiac surgery. Cardioplegic infusion duration will be infused over 300s. | Drug: Cold blood cardioplegia (large volume)<br>* Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg<br>|
| Active Comparator: Group S<br>Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg The content of cardioplegic solution will be (K+, 30mmol/L) lidocaine 150 mg/L, magnesium sulphate 3 gm/L, dextrose 25% 25 mL/L and sodium bicarbonate 8.4% 25 mL/L during cardiac surgery. | Drug: Cold blood cardioplegia (small volume)<br>* Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac rhythm on return | Sinus rhythm or Ventricular Fibrillation: DC will be used or not and if used how much joules and how many times. | within the first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The inotropic score | 1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. (i.e. 1 point is assigned for each 10 ng/kg/min of epinephrine, norepinephrine, and phenylephrine. | within one month | 
| Cardiac dysrhythmias | Cardiac dysrhythmias during intensive care unit stay | within the first week | 
| blood pressure | blood pressure | within the first 24 hours | 
| transthoracic echocardiography (TTE) changes | Changes in ejection fraction by TTE | within the first week | 
| Troponin I levels | We will obtain blood samples for troponin I levels (as a marker of myocardial ischemia) pre-CBP, 6, 12 and 24 hours after the surgery. | within the first 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial protection, potassium cardioplegia, tropinin, Custodiol