Pediatric Myocardial Protection With Potassium Cardioplegia

Pediatric Myocardial Protection; Large Volume Potassium Cardioplegia Advantageous Over Small Volume Potassium Cardioplegia: Where do we Stand?

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

Study Overview

• Status: Completed
• Conditions: Cardioplegia
• Intervention / Treatment: Drug: Cold blood cardioplegia (large volume); Drug: Cold blood cardioplegia (small volume)

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

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: 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
ACTIVE_COMPARATOR: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within the first 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within one month
Cardiac dysrhythmias	Cardiac dysrhythmias during intensive care unit stay	within the first week
blood pressure	blood pressure	within the first 24 hours
transthoracic echocardiography (TTE) changes	Changes in ejection fraction by TTE	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.	within the first 24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2017
• Primary Completion (ACTUAL): April 3, 2018
• Study Completion (ACTUAL): April 28, 2018

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (ACTUAL): July 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: myocardial protection; potassium cardioplegia; tropinin; Custodiol
• Other Study ID Numbers: IRB00008715918

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No