Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06235424
Study type	Interventional
Source	Medical University of Gdansk
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	October 1, 2018
Completion date	September 24, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04149600` - Identification of Genetic Causes of Calcific Aortic Valve Disease
Recruiting	`NCT06001489` - The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy	N/A
Not yet recruiting	`NCT04430972` - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Completed	`NCT02467062` - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.	N/A
Not yet recruiting	`NCT02221921` - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI	N/A
Terminated	`NCT02128841` - Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.	Phase 2
Active, not recruiting	`NCT01194362` - A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
Not yet recruiting	`NCT05975567` - Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Recruiting	`NCT06025149` - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed	`NCT05082337` - The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures	N/A
Completed	`NCT05193760` - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Not yet recruiting	`NCT05941455` - A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve	N/A
Active, not recruiting	`NCT04950192` - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Active, not recruiting	`NCT03924661` - SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
Completed	`NCT04073875` - 18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis
Recruiting	`NCT03121053` - Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement	Phase 4
Completed	`NCT02000544` - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit	N/A
Completed	`NCT02981004` - PAR I - Patient-to-Annulus Relation I
Completed	`NCT02688153` - EDWARDS INTUITY Valve System CADENCE Study	N/A
Recruiting	`NCT06126367` - Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease