Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 15, 2020
Date Accepted: Apr 20, 2020
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Del Nido cardioplegia versus cold blood cardioplegia in adult cardiac surgery: study protocol for a randomized controlled trial.
ABSTRACT
Background:
The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. Del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction, more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement or combined procedures. Recently, a meta-analysis based on 9 retrospective studies has been published claiming the non-inferiority of Del Nido solution compared to other conventional cardioplegia solutions. Currently there are no prospective randomized studies whose primary outcome is the assessment of Del Nido solution clinical efficacy compared to other solutions commonly used in adult patients.
Objective:
The aim of this randomized clinical trial is to assess the benefits of Del Nido solution compared to Cardibraun blood cardioplegia solution in clinical terms of myocardial protection.
Methods:
This is the protocol of a controlled, randomized, single-center clinical trial carried out in the University Hospital Puerta de Hierro Majadahonda, in Spain. 474 participants over the age of 18 undergoing elective cardiac surgery with cardiopulmonary bypass will be simple randomized to receive Del Nido cardioplegia solution or Cardibraun blood cardioplegia solution.
Results:
The primary outcome will analyze the differences regarding myocardial protection in biochemical terms (perioperative troponin levels) and clinical terms (presence of the composite variable “acute cardiovascular event”).
Conclusions:
This protocol intends to resolve potential benefits of Del Nido cardioplegia solution in clinical terms regarding myocardial protection. Clinical Trial: This trial is registered in EU Clinical Trials Register under the number EUDRA-CT 2017-005144-14 in April 2018. ClinicalTrials.gov Identifier NCT04094168. (Retrospectively registered).
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