The goal of this clinical trial is to compare del Nido and Bretschneider-HTK (HTK) cardioplegia solutions in patients undergoing elective aortic valve replacement. The main question it aims to answer is: • Does the del Nido cardioplegia provide better cardioprotection and clinical outcomes than HTK cardioplegia? Participants will receive one of the investigated cardioplegia solutions according to the randomization. Researchers will compare both groups in terms of cardioprotection (described as levels of CK-MB and hsTnI), in-hospital clinical outcomes, biochemical changes in coronary sinus blood and one-year follow-up.
The idea of using del Nido cardioplegia in adult cardiac surgery appeared after many reports proving its safety and efficacy in the paediatric population. Therefore many adult centres started to apply it in everyday practice. Despite its growing popularity and application in different types of cardiac surgeries, there is still an insufficient number of prospective randomized trials which compare del Nido cardioplegia with the Bretschneider-HTK formula in the adult population. The described problem will be analyzed at different levels in this prospective, randomised study. Clinical aspects - del Nido and HTK cardioplegia will be compared in terms of intraoperative and postoperative details such as perfusion details and concentration of cardiac enzymes. Echocardiographic changes - The next step will be revealing potential echocardiographic changes in cardiac function in short- and long-term observations after cardiac surgery. Metabolic changes - the metabolic profile of amino acids and nucleotide changes after each cardioplegia solution delivery will be analyzed. Statistical calculations will be performed by a qualified statistician. In the case of binary variables, Fisher's exact test will be used to assess differences between groups. In the case of quantitative variables, the compliance of the distribution with the normal distribution will be tested using the Shapiro-Wilk test. For quantitative variables with a distribution not significantly different from normal, the Student's t-test will be used for comparison between groups. If the distribution differs significantly from the normal distribution, the Mann-Whitney U test (comparisons of two samples) or the Kruskal-Wallis test (comparisons of many samples) will be used. Correlations between variables will be assessed using the Pearson or Spearman method, depending on the distribution of the variables. Repeated-measures ANOVA will be used to assess the variability of biochemical parameters over time. In all analyses, p\<0.05 will be considered as the level of statistical significance. A comparison of the two cardioplegia solutions would allow assessing whether del Nido provides better cardioprotection than HTK.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
The route of cardioplegia delivery differed according to surgeons' preferences. The total dosage of cardioplegia depends on the type of cardioplegia. The standard dose of del Nido cardioplegia in our institution is 1000 ml as an initial dose and is delivered with a system pressure of 90-150 mmHg. The solution is prepared by our hospital's pharmacy. At 60. minute of cross-clamp (XC) if XC time was expected to exceed 90 minutes another dose of solution would be delivered. The volume of an additional dose was 500 ml. The temperature of the delivered del Nido cardioplegia was 4\*C.
The route of cardioplegia delivery differed according to surgeons' preferences. The dose of the HTK cardioplegia is calculated with an application of 20 mL/kg rule. It is delivered with a system pressure of 90-150 mmHg. If the XC time exceeds 120 minutes additional dose is given (10 mL/kg rule). The temperature of the delivered crystalloid cardioplegia is 4\*C
Medical University of Gdańsk
Gdansk, Pomeranian Voivodeship, Poland
postoperative CK-MB
concentration of serum creatine kinase-myocardial band (CK-MB)
Time frame: measured in the 6th, 24th, and 48th hour postoperatively
postoperative hsTnI
concentration of serum high sensitive cardiac troponin I (hsTnI)
Time frame: measured in the 6th, 24th, and 48th hour postoperatively
CPB time
Time of cardiopulmonary bypass (CPB).
Time frame: intraoperative
XC time
Time of aortic cross-clamp (XC).
Time frame: intraoperative
Reperfusion time
Time of reperfusion (between removal of cross-clamp and weaning from cardiopulmonary bypass).
Time frame: intraoperative
Cardioplegia volume
Total volume cardioplegia doses.
Time frame: intraoperative
Cardioplegia doses
Number of cardioplegia doses.
Time frame: intraoperative
Heart rhythm after XC
Type of heart rhythm after removal of aortic cross-clamp.
Time frame: intraoperative
Need for defibrillation
Need for heart defibrillations in case of ventricular fibrillation.
Time frame: intraoperative
Number of defibrillations
Number of heart defibrillations in case of ventricular fibrillation.
Time frame: intraoperative
Intraoperative lactate concentration
Lactate measured before XC, at the time of the biggest hemodilution, and after CPB.
Time frame: intraoperative
Intraoperative pH results
pH measured before XC, at the time of the biggest hemodilution, and after CPB.
Time frame: intraoperative
Intraoperative partial pressure of oxygen
Partial pressure of oxygen measured before XC, at the time of the biggest hemodilution, and after CPB.
Time frame: intraoperative
Intraoperative partial pressure of carbon dioxide
Partial pressure of carbon dioxide measured before XC, at the time of the biggest hemodilution, and after CPB.
Time frame: intraoperative
Intraoperative base deficit
Base deficit measured before XC, at the time of the biggest hemodilution, and after CPB.
Time frame: intraoperative
Intraoperative sodium and potassium concentration
Sodium and potassium concentration measured before XC, at the time of the biggest hemodilution, and after CPB.
Time frame: intraoperative
Intraoperative amino acids concentrations
Changes of amino acid concentrations in systemic and coronary sinus blood Before the procedure - sample from the peripheral arterial line before the start of the procedure. During cardiopulmonary bypass - samples from the peripheral arterial line and samples from the coronary sinus at 1. and 5. minute after aortic cross-clamp removal. Blood from the coronary sinus would be collected by cannula for retrograde cardioplegia delivery. During reperfusion - peripheral arterial line blood sample would be collected after weaning from cardiopulmonary bypass.
Time frame: intraoperative
Intraoperative nucleotides concentrations
changes of nucleotides concentrations in systemic and coronary sinus blood Before the procedure - sample from the peripheral arterial line before the start of the procedure. During cardiopulmonary bypass - samples from the peripheral arterial line and samples from the coronary sinus at 1. and 5. minute after aortic cross-clamp removal. Blood from the coronary sinus would be collected by cannula for retrograde cardioplegia delivery. During reperfusion - peripheral arterial line blood sample would be collected after weaning from cardiopulmonary bypass.
Time frame: intraoperative
Ventilation time
Time of mechanical ventilation after surgery.
Time frame: 30 postoperative days
ICU length of stay
Intensive care unit (ICU) length of stay.
Time frame: 30 postoperative days
Hospital length of stay
Hospital length of stay.
Time frame: 30 postoperative days
Postoperative lactate concentration
Lactate measured at 6th, 24th, and 48th hour postoperatively.
Time frame: 30 postoperative days
Postoperative pH results
pH measured at 6th, 24th, and 48th hour postoperatively.
Time frame: 30 postoperative days
Postoperative partial pressure of oxygen
Partial pressure of oxygen measured at 6th, 24th, and 48th hour postoperatively.
Time frame: 30 postoperative days
Postoperative partial pressure of carbon dioxide
Partial pressure of carbon dioxide measured at 6th, 24th, and 48th hour postoperatively.
Time frame: 30 postoperative days
Postoperative base deficit
Base deficit measured at 6th, 24th, and 48th hour postoperatively.
Time frame: 30 postoperative days
Postoperative sodium and potassium levels
Sodium and potassium levels measured at 6th, 24th, and 48th hour postoperatively.
Time frame: 30 postoperative days
Maximum CRP concentration
Maximum C reactive protein (CRP) concentration measured during hospitalization at our institution.
Time frame: 30 postoperative days
Discharge CRP concentration
CRP results at discharge from our institution.
Time frame: 30 postoperative days
Maximum creatinine concentration
Maximum creatinine concentration measured during hospitalization at our institution.
Time frame: 30 postoperative days
Discharge creatinine concentration
Creatinine results at discharge from our institution.
Time frame: 30 postoperative days
Discharge Hb concentration
Hemoglobin (Hb) results at discharge from our institution.
Time frame: 30 postoperative days
Discharge Hct concentration
Hematocrit (Hct) results at discharge from our institution.
Time frame: 30 postoperative days
Discharge WBC concentration
White blood cells count (WBC) results at discharge from our institution.
Time frame: 30 postoperative days
VIS
Vasoactive-inotropic score (VIS) at 6th, 24th, and 48th hour postoperatively.
Time frame: 30 postoperative days
Rate of postoperative transfusions
Rate of postoperative blood product transfusions.
Time frame: 30 postoperative days
Rate of resternotomy
Rate of bleeding with the need for re-sternotomy during the early postoperative period.
Time frame: 30 postoperative days
Rate of pericardial drainage
Rate of pericardial drainages during the early postoperative period.
Time frame: 30 postoperative days
Rate of stroke
Rate of stokes during the early postoperative period.
Time frame: 30 postoperative days
Rate of myocardial infarction
Rate of myocardial infarction during the early postoperative period.
Time frame: 30 postoperative days
Rate of new-onset arrhythmias
Rate of new-onset arrhythmias (atrial fibrillation, heart block) during the early postoperative period.
Time frame: 30 postoperative days
In-hospital mortality rate
Rate of postoperative deaths that occurred during initial hospitalization.
Time frame: 30 postoperative days
Out-hospital mortality rate
Rate of postoperative deaths that occurred after hospital discharge.
Time frame: approx one year postoperatively
Rate of pacemaker implantation
Pacemaker implantation in postoperative period.
Time frame: approx one year postoperatively
Rate of secondary hospitalization
Rate of secondary hospitalization due to late complications or other cardiac-related reasons
Time frame: approx one year postoperatively
LVEF values changes
Left ventricular ejection fraction (LVEF) will be measured during an echocardiography test before surgery, before discharge and one year after surgery.
Time frame: approx one year postoperatively
Diastolic function changes
Diastolic function measured during an echocardiography test before surgery, before discharge and one year after surgery.
Time frame: approx one year postoperatively
2STE parameter changes
2STE parameter changes (with special attention put on the ventricular septum, new hypokinetic or akinetic areas) measured during an echocardiography test before surgery, before discharge and one year after surgery.
Time frame: approx one year postoperatively
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