Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06235424
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-12-05
Brief Title:
Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement
Sponsor:
Medical University of Gdansk
Organization:
Medical University of Gdansk
Study Overview
Official Title:
Comparison of Low Sodium Crystalloid Bretschneider-HTK Cardioplegia With Del Nido Cardioplegia in Patients Undergoing Elective Aortic Valve Replacement - a Prospective Randomized Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Fishers 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 Students 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 p005 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
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 Fishers 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 Students 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 p005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None