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
Verified date | January 2024 |
Source | Medical University of Gdansk |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Gdansk | Gdansk | Pomorskie |
Lead Sponsor | Collaborator |
---|---|
Medical University of Gdansk |
Poland,
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 |
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