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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| del Nido cardioplegia group | Active Comparator | A group of patients that received high potassium cardioplegic solution with the addition of lidocaine, mixed with the patient's blood in 4:1 ratio |
|
| Bretschneider-HTK cardioplegia group | Active Comparator | A group of patients that received low sodium cardioplegic solution with the addition of histidine, tryptophan and alpha-ketoglutarate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Del Nido Cardioplegia Solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative CK-MB | concentration of serum creatine kinase-myocardial band (CK-MB) | measured in the 6th, 24th, and 48th hour postoperatively |
| postoperative hsTnI | concentration of serum high sensitive cardiac troponin I (hsTnI) | measured in the 6th, 24th, and 48th hour postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| CPB time | Time of cardiopulmonary bypass (CPB). | intraoperative |
| XC time | Time of aortic cross-clamp (XC). | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Brzeska, MD | Medical Univeristy of Gdansk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Gdańsk | Gdansk | Pomeranian Voivodeship | 80-282 | Poland |
Data obtained through this study may be provided to qualified researchers with an interest in cardioprotection. Data or samples shared will be coded, with no PHI included.
The data underlying this article will be shared on reasonable request.
was not yet determined
The data underlying this article will be shared on reasonable request
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| C000712134 | Del Nido cardioplegia solution |
| C039984 | Bretschneider cardioplegic solution |
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| HTK solution | Drug | 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 |
|
|
| Reperfusion time | Time of reperfusion (between removal of cross-clamp and weaning from cardiopulmonary bypass). | intraoperative |
| Cardioplegia volume | Total volume cardioplegia doses. | intraoperative |
| Cardioplegia doses | Number of cardioplegia doses. | intraoperative |
| Heart rhythm after XC | Type of heart rhythm after removal of aortic cross-clamp. | intraoperative |
| Need for defibrillation | Need for heart defibrillations in case of ventricular fibrillation. | intraoperative |
| Number of defibrillations | Number of heart defibrillations in case of ventricular fibrillation. | intraoperative |
| Intraoperative lactate concentration | Lactate measured before XC, at the time of the biggest hemodilution, and after CPB. | intraoperative |
| Intraoperative pH results | pH measured before XC, at the time of the biggest hemodilution, and after CPB. | intraoperative |
| Intraoperative partial pressure of oxygen | Partial pressure of oxygen measured before XC, at the time of the biggest hemodilution, and after CPB. | 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. | intraoperative |
| Intraoperative base deficit | Base deficit measured before XC, at the time of the biggest hemodilution, and after CPB. | intraoperative |
| Intraoperative sodium and potassium concentration | Sodium and potassium concentration measured before XC, at the time of the biggest hemodilution, and after CPB. | 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. | 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. | intraoperative |
| Ventilation time | Time of mechanical ventilation after surgery. | 30 postoperative days |
| ICU length of stay | Intensive care unit (ICU) length of stay. | 30 postoperative days |
| Hospital length of stay | Hospital length of stay. | 30 postoperative days |
| Postoperative lactate concentration | Lactate measured at 6th, 24th, and 48th hour postoperatively. | 30 postoperative days |
| Postoperative pH results | pH measured at 6th, 24th, and 48th hour postoperatively. | 30 postoperative days |
| Postoperative partial pressure of oxygen | Partial pressure of oxygen measured at 6th, 24th, and 48th hour postoperatively. | 30 postoperative days |
| Postoperative partial pressure of carbon dioxide | Partial pressure of carbon dioxide measured at 6th, 24th, and 48th hour postoperatively. | 30 postoperative days |
| Postoperative base deficit | Base deficit measured at 6th, 24th, and 48th hour postoperatively. | 30 postoperative days |
| Postoperative sodium and potassium levels | Sodium and potassium levels measured at 6th, 24th, and 48th hour postoperatively. | 30 postoperative days |
| Maximum CRP concentration | Maximum C reactive protein (CRP) concentration measured during hospitalization at our institution. | 30 postoperative days |
| Discharge CRP concentration | CRP results at discharge from our institution. | 30 postoperative days |
| Maximum creatinine concentration | Maximum creatinine concentration measured during hospitalization at our institution. | 30 postoperative days |
| Discharge creatinine concentration | Creatinine results at discharge from our institution. | 30 postoperative days |
| Discharge Hb concentration | Hemoglobin (Hb) results at discharge from our institution. | 30 postoperative days |
| Discharge Hct concentration | Hematocrit (Hct) results at discharge from our institution. | 30 postoperative days |
| Discharge WBC concentration | White blood cells count (WBC) results at discharge from our institution. | 30 postoperative days |
| VIS | Vasoactive-inotropic score (VIS) at 6th, 24th, and 48th hour postoperatively. | 30 postoperative days |
| Rate of postoperative transfusions | Rate of postoperative blood product transfusions. | 30 postoperative days |
| Rate of resternotomy | Rate of bleeding with the need for re-sternotomy during the early postoperative period. | 30 postoperative days |
| Rate of pericardial drainage | Rate of pericardial drainages during the early postoperative period. | 30 postoperative days |
| Rate of stroke | Rate of stokes during the early postoperative period. | 30 postoperative days |
| Rate of myocardial infarction | Rate of myocardial infarction during the early postoperative period. | 30 postoperative days |
| Rate of new-onset arrhythmias | Rate of new-onset arrhythmias (atrial fibrillation, heart block) during the early postoperative period. | 30 postoperative days |
| In-hospital mortality rate | Rate of postoperative deaths that occurred during initial hospitalization. | 30 postoperative days |
| Out-hospital mortality rate | Rate of postoperative deaths that occurred after hospital discharge. | approx one year postoperatively |
| Rate of pacemaker implantation | Pacemaker implantation in postoperative period. | approx one year postoperatively |
| Rate of secondary hospitalization | Rate of secondary hospitalization due to late complications or other cardiac-related reasons | 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. | approx one year postoperatively |
| Diastolic function changes | Diastolic function measured during an echocardiography test before surgery, before discharge and one year after surgery. | 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. | approx one year postoperatively |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |