The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement

Study Overview
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Brief Summary
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A group of 150 patients undergoing aortic valve replacement procedure will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants). The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).

Detailed Description
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The del Nido cardioplegia was developed by Pedro del Nido and his team at the University of Pittsburgh in 1990s. It was primarily designed for children and it has been used in pediatric cardiac surgery in Boston's Children Hospital since 1994. There are few studies regarding the del Nido cardioplegia. A prospective, randomized trial was designed to determine the efficiency of the del Nido cardioplegia when compared to multidose cold blood cardioplegia in cardiac procedures with short and moderate cross-clamp times. For the analysis of two cardioprotection protocols, it is essential to compare groups equal in terms of the surgery and perioperative care, with the same surgical risk and cross-clamp time. The research required elimination of all the unnecessary variables. The patients undergoing aortic valve replacement procedure were selected as a study population. A group of 150 patients will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants). The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).

Official Title
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The Del Nido Cardioplegia Versus the Cold Blood Cardioplegia in Adult Patients Undergoing Aortic Valve Replacement

Conditions
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Aortic Valve Disease, Ischemia-reperfusion Injury

Intervention / Treatment
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* Drug: del Nido cardioplegia
* Drug: cold blood cardioplegia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: qualification for isolated aortic valve replacement age>18 years given consent for the study Exclusion Criteria: reoperation allergy to lidocaine coronary artery disease requiring surgical or percutaneous intervention pregnancy ejection fraction<30% massive aortic calcification (porcelain aorta)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: del Nido cardioplegia<br> | Drug: del Nido cardioplegia<br>* The del Nido components are: Plasma-Lyte A (1000ml), Mannitol 20% (16.3ml), MgSO4 50% (4ml) , NaHCO3 8.4% (13ml) , KCl 2mEq/mL (13ml), Lidocaine 1% (13ml). This solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 4:1 ratio (crystalloid:blood). The dosage is 20ml/kg. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius. Additional dose of the cardioplegia is given only if the cross-clamp time exceeds 90 minutes. Due to high volume given in a single delivery, 40 milligrams of furosemide are injected into cardiopulmonary circuit.<br>|
| Active Comparator: cold blood cardioplegia<br> | Drug: cold blood cardioplegia<br>* The cold blood cardioplegia components are: Plasma-Lyte A (435ml), Mannitol 15% (20ml), NaHCO3 8.4% (20ml), KCl 2mEq/mL (25ml). The solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 1:4 ratio (crystalloid:blood). The initial dose is 15ml/kg and a dose of 5ml/kg is added every 20-30 minutes or whenever cardiac activity is observed. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical cardiac activity during cross-clamp | Electrical activity observed during the cardiac arrest (cross-clamp) | intraoperative | 
| Ventricular fibrillation during reperfusion | Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp | intraoperative | 
| hs-TnT (High sensitivity troponin T) - 24 hours | High sensitivity troponin T measured 24 hours postoperatively | 24 hours postoperatively | 
| hs-TnT (High sensitivity troponin T) - 48 hours | High sensitivity troponin T measured 48 hours postoperatively | 48 hours postoperatively | 
| CK-MB (Creatine kinase- MB isoenzyme) - 24 hours | Creatine kinase (MB isoenzyme) measured 24 hours postoperatively | 24 hours postoperatively | 
| CK-MB (Creatine kinase- MB isoenzyme) - 48 hours | Creatine kinase (MB isoenzyme) measured 48 hours postoperatively | 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular fibrillation during the cardioplegia administration |  | intraoperative | 
| Time from the beginning of cardioplegia administration to cardiac arrest |  | intraoperative | 
| Procedural use of the pacemaker |  | intraoperative | 
| Intraoperative myocardial infarction |  | intraoperative | 
| Fall of ejection fraction (EF) | 5% fall in the EF | 48 hours | 
| Inotrope administration |  | intraoperative, 48 hours | 
| Use of the intraaortic balloon pump |  | intraoperative, 48 hours | 
| Perioperative atrial fibrillation |  | up to 2 weeks | 
| Perioperative arrhythmia (other than AF) |  | up to 2 weeks | 
| Postoperative packed red blood cells transfusion |  | up to 2 weeks | 
| Perioperative creatinine values |  | up to 2 weeks | 
| Kidney injury | The creatinine elevation >25% or >0.5mg/dl | up to 2 weeks | 
| CVVHDF | Use of continous veno-venous hemodiafiltration | up to 2 weeks | 
| Cardiac death | death from cardiac reasons (e.g. myocardial infarction, low ejection fraction, arrhythmia). | 30 days postoperative | 
| Overall mortality |  | 30 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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del Nido, cardioplegia, aortic valve