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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
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.
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.
1st Department of Cardiac Surgery
Bielsko-Biala, Poland
Electrical cardiac activity during cross-clamp
Electrical activity observed during the cardiac arrest (cross-clamp)
Time frame: intraoperative
Ventricular fibrillation during reperfusion
Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp
Time frame: intraoperative
hs-TnT (High sensitivity troponin T) - 24 hours
High sensitivity troponin T measured 24 hours postoperatively
Time frame: 24 hours postoperatively
hs-TnT (High sensitivity troponin T) - 48 hours
High sensitivity troponin T measured 48 hours postoperatively
Time frame: 48 hours postoperatively
CK-MB (Creatine kinase- MB isoenzyme) - 24 hours
Creatine kinase (MB isoenzyme) measured 24 hours postoperatively
Time frame: 24 hours postoperatively
CK-MB (Creatine kinase- MB isoenzyme) - 48 hours
Creatine kinase (MB isoenzyme) measured 48 hours postoperatively
Time frame: 48 hours postoperatively
Ventricular fibrillation during the cardioplegia administration
Time frame: intraoperative
Time from the beginning of cardioplegia administration to cardiac arrest
Time frame: intraoperative
Procedural use of the pacemaker
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Time frame: intraoperative
Intraoperative myocardial infarction
Time frame: intraoperative
Fall of ejection fraction (EF)
5% fall in the EF
Time frame: 48 hours
Inotrope administration
Time frame: intraoperative, 48 hours
Use of the intraaortic balloon pump
Time frame: intraoperative, 48 hours
Perioperative atrial fibrillation
Time frame: up to 2 weeks
Perioperative arrhythmia (other than AF)
Time frame: up to 2 weeks
Postoperative packed red blood cells transfusion
Time frame: up to 2 weeks
Perioperative creatinine values
Time frame: up to 2 weeks
Kidney injury
The creatinine elevation \>25% or \>0.5mg/dl
Time frame: up to 2 weeks
CVVHDF
Use of continous veno-venous hemodiafiltration
Time frame: up to 2 weeks
Cardiac death
death from cardiac reasons (e.g. myocardial infarction, low ejection fraction, arrhythmia).
Time frame: 30 days postoperative
Overall mortality
Time frame: 30 days postoperative