Pediatric Myocardial Protection With Potassium Cardioplegia

Assiut University

Status and phase: Completed; Phase 2

Conditions: Cardioplegia

Treatments: Drug: Cold blood cardioplegia (small volume); Drug: Cold blood cardioplegia (large volume)

Study type: Interventional

Funder types: Other

Identifiers

NCT03229980

IRB00008715918

Details and patient eligibility

About

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

Full 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

Enrollment: 87 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 2 patient groups

Group L

Active Comparator group

Description:

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.

Treatment:

Drug: Cold blood cardioplegia (large volume)

Group S

Active Comparator group

Description:

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.

Treatment:

Drug: Cold blood cardioplegia (small volume)