Del Nido cardioplegia vs Custodiol© cardioplegia in coronary artery bypass graft surgery: a prospective randomized clinical trial

Abstract

BACKGROUND: Coronary Artery Disease is one of the most prevalent conditions in our society, resulting in Coronary Artery Bypass Grafting being the most performed heart surgery and one of the most common surgeries in today’s medical practice. From an anaesthesiologic point of view, cardioprotection of the heart is of the most importance during the procedure. The challenge of bringing the heart into an elective diastolic arrest has been in discussion since the first cardioplegic strategies were introduced in the 60s. Nowadays, single-dose hyperpolarizing cardioplegic solutions such as Del Nido cardioplegia and Custodiol© cardioplegia are part of the regular medical practice without enough evidence regarding its use in high risk patients, and with no quality clinical trials comparing the two solutions. OBJECTIVE: The main objective is to asses which of the two cardioplegic solutions provides a better return to spontaneous sinus rhythm after the aortic cross-clamp removal in patients undergoing CABG surgery. Secondary objectives will be the comparison of LCOS incidence in the first 24 hours, need for defibrillation in the first 24 hours and mortality after 30-days in patients undergoing CABG surgery. DESIGN: The study will be a prospective, randomized, double-blinded clinical trial carried out in the Dr. Josep Trueta University Hospital of Girona. INTERVENTION AND METHODS: Patients over 18 years old scheduled for CABG surgery in University Hospital Dr. Josep Trueta of Girona will be identified in the pre-operatory anaesthesiology visit. Patients with acute kidney failure, chronic kidney disease in stages G4 or G5, dependent on dialysis or with an implanted peacemaker will be excluded. They will be randomly divided in two groups: group A (n=62) will receive Del Nido cardioplegia, and Group B (n=62) will receive Custodiol© cardioplegia. The spontaneous return to sinus rhythm after the aortic cross-clamp removal will be assessed. The incidence of LCOS in the first 24 hours, need for defibrillation in the first 24 hours and the mortality after 30 days will also be compiled as secondary objectives