Pediatric Myocardial Protection With Potassium Cardioplegia

NCT ID: NCT03229980

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-10
• Study Completion Date: 2018-04-28

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

Conditions

Cardioplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group L

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.

Group Type: ACTIVE_COMPARATOR

Cold blood cardioplegia (large volume)

Intervention Type: 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

Group S

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.

Group Type: ACTIVE_COMPARATOR

Cold blood cardioplegia (small volume)

Intervention Type: 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

Interventions

Cold 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

Intervention Type: DRUG

Cold 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sayed Kaoud Abd-Elshafy

Associate Profossor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sayed k Abd-Elshafy, MD

Role: PRINCIPAL_INVESTIGATOR

Associate profossor of anesthesiology

Locations

Faculty of Medicine

Asyut, , Egypt

Countries

Egypt

Other Identifiers

IRB00008715918

Identifier Type: -

Identifier Source: org_study_id