Cardiomyopathies, Pathological Processes
Conditions
Keywords
Cardioplegia, Cardiac Surgery, Adenosine, Therapeutic Uses, Intermittent warm blood cardioplegia, Minimally Invasive Surgery, minimally invasive mitral valve plasty (mini-MPL), minimally invasive mitral valve replacement (mini-MVR)
Brief summary
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate the effect of the addition of adenosine to standard intermittent warm blood cardioplegia in patients scheduled for minimally invasive, port access operations (mitral valve surgery). Half of the participants will receive standard intermittent warm blood cardioplegia, while the other half will receive intermittent warm blood cardioplegia enriched with adenosine.
Detailed description
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate whether the addition of adenosine to standard intermittent warm blood cardioplegia reduces the 6-hours post-operative cardiac troponin T (cTnT) in patients scheduled for minimally invasive, port access operations (mitral valve surgery).
Interventions
DRUGAdenosine
This group receives intermittent warm blood cardioplegia enriched with adenosine
Sponsors
Amphia Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Elective cardiac surgical patients * minimally invasive, port access surgery (mitral valve surgery)
Exclusion criteria
* All non-minimally invasive, port access surgery * Theophylline or dipyridamole use up to 24 hours prior to surgery * Products that contain caffeine of theobromine up to 12 hours prior to surgery (coffee, chocolate, energizing drinks (e.g. Red Bull), tea, soda (coke), etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-hour cardiac Troponin T (cTnT) release | 6 hours post-operative | The primary end point is 6-hour cTnT release |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vasoactive-inotropic score | participants will be followed for the duration of ICU stay, an expected average of 2 days | The hourly doses of the following inotropic and vasoactive medications are recorded for the first 18 h after post-operative admission to the ICU: dopamine, dobutamine, epinephrine, norepinephrine, milrinone and vasopressin. |
| 18-hour cardiac Troponin T (cTnT) area under the curve (AUC) release | cardiac Troponin T (cTnT) AUC will be assessed at different time points, the latest up to 18 hours after ICU arrival | 18-hour postoperative AUC release of cardiac troponin T Routine blood samples pre-operatively from peripheral blood (T0); post-operatively, from peripheral blood, at arrival at ICU (T1) and 6 hours after arrival at ICU (T2), and 18 hours after arrival at ICU (T3). |
| Incidence of myocardial injury on 12-lead ECG | participants will be followed for the duration of ICU stay, an expected average of 2 days | Incidence of myocardial injury on 12-lead ECG * New-onset Left bundle branch block (LBBB) * New-onset Q wave |
| Vasoconstrictor usage | participants will be followed for the duration of ICU stay, an expected average of 2 days | Vasoconstrictor usage yes/no |
| Routine blood samples | Routine blood samples will be assessed at different time points, the latest up to 6 hours after ICU arrival | The amount of creatine kinase MB (CK-MB) and Creatinine at different time intervals. preoperatively from peripheral blood (T0); post-operatively, from peripheral blood, at arrival at ICU (T1) and 6 hours after arrival at ICU (T2) |
| Incidence of new onset Atrial fibrillation (AF) | participants will be followed for the duration of ICU stay, an expected average of 2 days | Incidence of new onset AF |
| postoperative left ventricular ejection fraction (LVEF) | postoperative after skin closure, an expected average of 3 hours after starting surgery | 3-D transesophageal echocardiography (TEE) postoperative left ventricular ejection fraction (LVEF) after skin closure |
| Wall Motion Score Index (WMSI) | postoperative after skin closure, an expected average of 3 hours after starting surgery | 3-D transesophageal echocardiography (TEE) Wall Motion Score Index (WMSI) after skin closure |
| Heart rate (HR) | participants will be followed for the duration of ICU stay, an expected average of 2 days | Haemodynamic monitoring. Heart rate will be measured in beats per minute (bpm). |
| Cardiac index (CI) | participants will be followed for the duration of ICU stay, an expected average of 2 days | Cardiac index (CI) is a haemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA) |
| Systemic vascular resistance index (SVRI) | participants will be followed for the duration of ICU stay, an expected average of 2 days | SVRI = 80 x (MAP - RAP)/CI MAP = Mean Arterial Pressure (mmHg) RAP = Right Arterial Pressure (mmHg) CI = Cardiac Index (L/min/m2) |
| Mean arterial pressure (MAP) | participants will be followed for the duration of ICU stay, an expected average of 2 days | Haemodynamic monitoring |
Countries
Netherlands
Contacts
Primary ContactJeffrey Engelhart, PharmD
Backup ContactThierry Scohy, MD
Outcome results
None listed