Cardioplegia
Conditions
Keywords
myocardial protection, potassium cardioplegia, tropinin, Custodiol
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
Interventions
DRUGCold blood cardioplegia (large volume)
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
DRUGCold blood cardioplegia (small volume)
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
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac rhythm on return | within the first 24 hours | Sinus rhythm or Ventricular Fibrillation: DC will be used or not and if used how much joules and how many times. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The inotropic score | within one month | 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. |
| Cardiac dysrhythmias | within the first week | Cardiac dysrhythmias during intensive care unit stay |
| blood pressure | within the first 24 hours | blood pressure |
| transthoracic echocardiography (TTE) changes | within the first week | Changes in ejection fraction by TTE |
| Troponin I levels | within the first 24 hours | 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. |
Countries
Egypt
Outcome results
None listed