Pediatric Myocardial Protection With Potassium Cardioplegia

Phase 2

Completed

• Conditions: Cardioplegia
• Interventions: Drug: Cold blood cardioplegia (large volume); Drug: Cold blood cardioplegia (small volume)

• Registration Number: NCT03229980
• Lead Sponsor: Assiut University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-26
• Study Start: 2017-08-10
• Primary Completion: 2018-04-03
• Study Completion: 2018-04-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

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Exclusion Criteria

• Previous cardiac surgery.
• Urgent or emergent cases.
• Any known allergies to components of either cardioplegia solutions.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	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 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 S	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 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt