Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement

Aortic Valve Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06235424
• Other study ID #: NKBBN/203/2018
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: September 24, 2024

Study information

• Verified date: January 2024
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 24, 2024
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Cardiac Ischemia
• Coronary Artery Disease
• Heart Valve Diseases
• Ischemia
• Myocardial Ischemia
• Valve Disease, Heart

Intervention

Drug:
• Del Nido Cardioplegia Solution
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.
• HTK solution
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

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative CK-MB	concentration of serum creatine kinase-myocardial band (CK-MB)	measured in the 6th, 24th, and 48th hour postoperatively
Primary	postoperative hsTnI	concentration of serum high sensitive cardiac troponin I (hsTnI)	measured in the 6th, 24th, and 48th hour postoperatively
Secondary	CPB time	Time of cardiopulmonary bypass (CPB).	intraoperative
Secondary	XC time	Time of aortic cross-clamp (XC).	intraoperative
Secondary	Reperfusion time	Time of reperfusion (between removal of cross-clamp and weaning from cardiopulmonary bypass).	intraoperative
Secondary	Cardioplegia volume	Total volume cardioplegia doses.	intraoperative
Secondary	Cardioplegia doses	Number of cardioplegia doses.	intraoperative
Secondary	Heart rhythm after XC	Type of heart rhythm after removal of aortic cross-clamp.	intraoperative
Secondary	Need for defibrillation	Need for heart defibrillations in case of ventricular fibrillation.	intraoperative
Secondary	Number of defibrillations	Number of heart defibrillations in case of ventricular fibrillation.	intraoperative
Secondary	Intraoperative lactate concentration	Lactate measured before XC, at the time of the biggest hemodilution, and after CPB.	intraoperative
Secondary	Intraoperative pH results	pH measured before XC, at the time of the biggest hemodilution, and after CPB.	intraoperative
Secondary	Intraoperative partial pressure of oxygen	Partial pressure of oxygen measured before XC, at the time of the biggest hemodilution, and after CPB.	intraoperative
Secondary	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
Secondary	Intraoperative base deficit	Base deficit measured before XC, at the time of the biggest hemodilution, and after CPB.	intraoperative
Secondary	Intraoperative sodium and potassium concentration	Sodium and potassium concentration measured before XC, at the time of the biggest hemodilution, and after CPB.	intraoperative
Secondary	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
Secondary	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
Secondary	Ventilation time	Time of mechanical ventilation after surgery.	30 postoperative days
Secondary	ICU length of stay	Intensive care unit (ICU) length of stay.	30 postoperative days
Secondary	Hospital length of stay	Hospital length of stay.	30 postoperative days
Secondary	Postoperative lactate concentration	Lactate measured at 6th, 24th, and 48th hour postoperatively.	30 postoperative days
Secondary	Postoperative pH results	pH measured at 6th, 24th, and 48th hour postoperatively.	30 postoperative days
Secondary	Postoperative partial pressure of oxygen	Partial pressure of oxygen measured at 6th, 24th, and 48th hour postoperatively.	30 postoperative days
Secondary	Postoperative partial pressure of carbon dioxide	Partial pressure of carbon dioxide measured at 6th, 24th, and 48th hour postoperatively.	30 postoperative days
Secondary	Postoperative base deficit	Base deficit measured at 6th, 24th, and 48th hour postoperatively.	30 postoperative days
Secondary	Postoperative sodium and potassium levels	Sodium and potassium levels measured at 6th, 24th, and 48th hour postoperatively.	30 postoperative days
Secondary	Maximum CRP concentration	Maximum C reactive protein (CRP) concentration measured during hospitalization at our institution.	30 postoperative days
Secondary	Discharge CRP concentration	CRP results at discharge from our institution.	30 postoperative days
Secondary	Maximum creatinine concentration	Maximum creatinine concentration measured during hospitalization at our institution.	30 postoperative days
Secondary	Discharge creatinine concentration	Creatinine results at discharge from our institution.	30 postoperative days
Secondary	Discharge Hb concentration	Hemoglobin (Hb) results at discharge from our institution.	30 postoperative days
Secondary	Discharge Hct concentration	Hematocrit (Hct) results at discharge from our institution.	30 postoperative days
Secondary	Discharge WBC concentration	White blood cells count (WBC) results at discharge from our institution.	30 postoperative days
Secondary	VIS	Vasoactive-inotropic score (VIS) at 6th, 24th, and 48th hour postoperatively.	30 postoperative days
Secondary	Rate of postoperative transfusions	Rate of postoperative blood product transfusions.	30 postoperative days
Secondary	Rate of resternotomy	Rate of bleeding with the need for re-sternotomy during the early postoperative period.	30 postoperative days
Secondary	Rate of pericardial drainage	Rate of pericardial drainages during the early postoperative period.	30 postoperative days
Secondary	Rate of stroke	Rate of stokes during the early postoperative period.	30 postoperative days
Secondary	Rate of myocardial infarction	Rate of myocardial infarction during the early postoperative period.	30 postoperative days
Secondary	Rate of new-onset arrhythmias	Rate of new-onset arrhythmias (atrial fibrillation, heart block) during the early postoperative period.	30 postoperative days
Secondary	In-hospital mortality rate	Rate of postoperative deaths that occurred during initial hospitalization.	30 postoperative days
Secondary	Out-hospital mortality rate	Rate of postoperative deaths that occurred after hospital discharge.	approx one year postoperatively
Secondary	Rate of pacemaker implantation	Pacemaker implantation in postoperative period.	approx one year postoperatively
Secondary	Rate of secondary hospitalization	Rate of secondary hospitalization due to late complications or other cardiac-related reasons	approx one year postoperatively
Secondary	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
Secondary	Diastolic function changes	Diastolic function measured during an echocardiography test before surgery, before discharge and one year after surgery.	approx one year postoperatively
Secondary	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