Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06235424
Other study ID # NKBBN/203/2018
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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