Pediatric Myocardial Protection With Potassium Cardioplegia

Assiut University87 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cardioplegia

Interventions

Cold blood cardioplegia (large volume)DRUG

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

Cold blood cardioplegia (small volume)DRUG

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Medicine

Asyut, Egypt

Outcomes

Primary Outcomes

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.

Time frame: within the first 24 hours

Secondary Outcomes

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.

Time frame: within one month

Cardiac dysrhythmias

Cardiac dysrhythmias during intensive care unit stay

Time frame: within the first week

blood pressure

Time frame: within the first 24 hours

transthoracic echocardiography (TTE) changes

Changes in ejection fraction by TTE

Time frame: 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.

Time frame: within the first 24 hours

Data from ClinicalTrials.gov

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