Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement
- Conditions
- Aortic Valve DiseaseValve Disease, HeartCardiac Ischemia
- Interventions
- Drug: Del Nido Cardioplegia SolutionDrug: HTK solution
- Registration Number
- NCT06235424
- Lead Sponsor
- Medical University of Gdansk
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- patients aged 18 and over,
- qualified for elective isolated aortic valve replacement (AVR)
- patients with significant coronary artery disease,
- urgent cases,
- cases with additional cardiac procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description del Nido cardioplegia group Del Nido Cardioplegia Solution 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 HTK solution A group of patients that received low sodium cardioplegic solution with the addition of histidine, tryptophan and alpha-ketoglutarate
- Primary Outcome Measures
Name Time Method postoperative CK-MB measured in the 6th, 24th, and 48th hour postoperatively concentration of serum creatine kinase-myocardial band (CK-MB)
postoperative hsTnI measured in the 6th, 24th, and 48th hour postoperatively concentration of serum high sensitive cardiac troponin I (hsTnI)
- Secondary Outcome Measures
Name Time Method Rate of postoperative transfusions 30 postoperative days Rate of postoperative blood product transfusions.
CPB time intraoperative Time of cardiopulmonary bypass (CPB).
XC time intraoperative Time of aortic cross-clamp (XC).
Reperfusion time intraoperative Time of reperfusion (between removal of cross-clamp and weaning from cardiopulmonary bypass).
Cardioplegia volume intraoperative Total volume cardioplegia doses.
Cardioplegia doses intraoperative Number of cardioplegia doses.
Heart rhythm after XC intraoperative Type of heart rhythm after removal of aortic cross-clamp.
Need for defibrillation intraoperative Need for heart defibrillations in case of ventricular fibrillation.
Number of defibrillations intraoperative Number of heart defibrillations in case of ventricular fibrillation.
Intraoperative lactate concentration intraoperative Lactate measured before XC, at the time of the biggest hemodilution, and after CPB.
Intraoperative pH results intraoperative pH measured before XC, at the time of the biggest hemodilution, and after CPB.
Intraoperative partial pressure of oxygen intraoperative Partial pressure of oxygen measured before XC, at the time of the biggest hemodilution, and after CPB.
Intraoperative partial pressure of carbon dioxide intraoperative Partial pressure of carbon dioxide measured before XC, at the time of the biggest hemodilution, and after CPB.
Intraoperative base deficit intraoperative Base deficit measured before XC, at the time of the biggest hemodilution, and after CPB.
Intraoperative sodium and potassium concentration intraoperative Sodium and potassium concentration measured before XC, at the time of the biggest hemodilution, and after CPB.
Intraoperative amino acids concentrations intraoperative 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 nucleotides concentrations intraoperative 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.Ventilation time 30 postoperative days Time of mechanical ventilation after surgery.
ICU length of stay 30 postoperative days Intensive care unit (ICU) length of stay.
Hospital length of stay 30 postoperative days Hospital length of stay.
Postoperative lactate concentration 30 postoperative days Lactate measured at 6th, 24th, and 48th hour postoperatively.
Postoperative pH results 30 postoperative days pH measured at 6th, 24th, and 48th hour postoperatively.
Postoperative partial pressure of oxygen 30 postoperative days Partial pressure of oxygen measured at 6th, 24th, and 48th hour postoperatively.
Postoperative partial pressure of carbon dioxide 30 postoperative days Partial pressure of carbon dioxide measured at 6th, 24th, and 48th hour postoperatively.
Postoperative base deficit 30 postoperative days Base deficit measured at 6th, 24th, and 48th hour postoperatively.
Postoperative sodium and potassium levels 30 postoperative days Sodium and potassium levels measured at 6th, 24th, and 48th hour postoperatively.
Maximum CRP concentration 30 postoperative days Maximum C reactive protein (CRP) concentration measured during hospitalization at our institution.
Discharge CRP concentration 30 postoperative days CRP results at discharge from our institution.
Maximum creatinine concentration 30 postoperative days Maximum creatinine concentration measured during hospitalization at our institution.
Discharge creatinine concentration 30 postoperative days Creatinine results at discharge from our institution.
Discharge Hb concentration 30 postoperative days Hemoglobin (Hb) results at discharge from our institution.
Discharge Hct concentration 30 postoperative days Hematocrit (Hct) results at discharge from our institution.
Discharge WBC concentration 30 postoperative days White blood cells count (WBC) results at discharge from our institution.
VIS 30 postoperative days Vasoactive-inotropic score (VIS) at 6th, 24th, and 48th hour postoperatively.
Rate of resternotomy 30 postoperative days Rate of bleeding with the need for re-sternotomy during the early postoperative period.
Rate of pericardial drainage 30 postoperative days Rate of pericardial drainages during the early postoperative period.
Rate of stroke 30 postoperative days Rate of stokes during the early postoperative period.
Rate of myocardial infarction 30 postoperative days Rate of myocardial infarction during the early postoperative period.
Rate of new-onset arrhythmias 30 postoperative days Rate of new-onset arrhythmias (atrial fibrillation, heart block) during the early postoperative period.
In-hospital mortality rate 30 postoperative days Rate of postoperative deaths that occurred during initial hospitalization.
Out-hospital mortality rate approx one year postoperatively Rate of postoperative deaths that occurred after hospital discharge.
Rate of pacemaker implantation approx one year postoperatively Pacemaker implantation in postoperative period.
Rate of secondary hospitalization approx one year postoperatively Rate of secondary hospitalization due to late complications or other cardiac-related reasons
LVEF values changes approx one year postoperatively Left ventricular ejection fraction (LVEF) will be measured during an echocardiography test before surgery, before discharge and one year after surgery.
Diastolic function changes approx one year postoperatively Diastolic function measured during an echocardiography test before surgery, before discharge and one year after surgery.
2STE parameter changes approx one year postoperatively 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.
Trial Locations
- Locations (1)
Medical University of Gdańsk
🇵🇱Gdańsk, Pomorskie, Poland