Clinical trial NCT06235424: Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Aortic Valve Disease
Valve Disease, Heart
Cardiac Ischemia
Keywords: del Nido cardioplegia
Bretschneider HTK cardioplegia
cardioprotection
cardiac surgery
aortic valve replacement
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* patients aged 18 and over,
* qualified for elective isolated aortic valve replacement (AVR)

Exclusion Criteria:

* patients with significant coronary artery disease,
* urgent cases,
* cases with additional cardiac procedures.

Primary outcomes:
measure: postoperative CK-MB
timeFrame: measured in the 6th, 24th, and 48th hour postoperatively
measure: postoperative hsTnI
timeFrame: measured in the 6th, 24th, and 48th hour postoperatively
Secondary outcomes:
measure: CPB time
timeFrame: intraoperative
measure: XC time
timeFrame: intraoperative
measure: Reperfusion time
timeFrame: intraoperative
measure: Cardioplegia volume
timeFrame: intraoperative
measure: Cardioplegia doses
timeFrame: intraoperative
measure: Heart rhythm after XC
timeFrame: intraoperative
measure: Need for defibrillation
timeFrame: intraoperative
measure: Number of defibrillations
timeFrame: intraoperative
measure: Intraoperative lactate concentration
timeFrame: intraoperative
measure: Intraoperative pH results
timeFrame: intraoperative
measure: Intraoperative partial pressure of oxygen
timeFrame: intraoperative
measure: Intraoperative partial pressure of carbon dioxide
timeFrame: intraoperative
measure: Intraoperative base deficit
timeFrame: intraoperative
measure: Intraoperative sodium and potassium concentration
timeFrame: intraoperative
measure: Intraoperative amino acids concentrations
timeFrame: intraoperative
measure: Intraoperative nucleotides concentrations
timeFrame: intraoperative
measure: Ventilation time
timeFrame: 30 postoperative days
measure: ICU length of stay
timeFrame: 30 postoperative days
measure: Hospital length of stay
timeFrame: 30 postoperative days
measure: Postoperative lactate concentration
timeFrame: 30 postoperative days
measure: Postoperative pH results
timeFrame: 30 postoperative days
measure: Postoperative partial pressure of oxygen
timeFrame: 30 postoperative days
measure: Postoperative partial pressure of carbon dioxide
timeFrame: 30 postoperative days
measure: Postoperative base deficit
timeFrame: 30 postoperative days
measure: Postoperative sodium and potassium levels
timeFrame: 30 postoperative days
measure: Maximum CRP concentration
timeFrame: 30 postoperative days
measure: Discharge CRP concentration
timeFrame: 30 postoperative days
measure: Maximum creatinine concentration
timeFrame: 30 postoperative days
measure: Discharge creatinine concentration
timeFrame: 30 postoperative days
measure: Discharge Hb concentration
timeFrame: 30 postoperative days
measure: Discharge Hct concentration
timeFrame: 30 postoperative days
measure: Discharge WBC concentration
timeFrame: 30 postoperative days
measure: VIS
timeFrame: 30 postoperative days
measure: Rate of postoperative transfusions
timeFrame: 30 postoperative days
measure: Rate of resternotomy
timeFrame: 30 postoperative days
measure: Rate of pericardial drainage
timeFrame: 30 postoperative days
measure: Rate of stroke
timeFrame: 30 postoperative days
measure: Rate of myocardial infarction
timeFrame: 30 postoperative days
measure: Rate of new-onset arrhythmias
timeFrame: 30 postoperative days
measure: In-hospital mortality rate
timeFrame: 30 postoperative days
measure: Out-hospital mortality rate
timeFrame: approx one year postoperatively
measure: Rate of pacemaker implantation
timeFrame: approx one year postoperatively
measure: Rate of secondary hospitalization
timeFrame: approx one year postoperatively
measure: LVEF values changes
timeFrame: approx one year postoperatively
measure: Diastolic function changes
timeFrame: approx one year postoperatively
measure: 2STE parameter changes
timeFrame: approx one year postoperatively
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
state: Pomorskie
Study officials:
affiliation: Medical Univeristy of Gdansk
name: Barbara Brzeska, MD
role: PRINCIPAL_INVESTIGATOR
References: