The aim of this study is to determine whether the addition of adenosine to standard intermittent warm blood cardioplegia reduces the 6-hours post-operative cTnT in patients scheduled for minimally invasive, port access operations (mitral valve…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the main study parameter is 6 hours post-operative cTnT.
Secondary outcome
Secondary outcomes are differences in 18-hour postoperative cTnT levels as
determined by the area-under-the-curve (AUC), differences in pre- and
post-operative creatine kinase-MB (CK-MB) levels, inotrope usage and dosage,
and differences in pre- and postoperative left ventricular ejection fraction
(LVEF) and wall motion score index (WMSI) determined by 3-dimensional
transesophageal echocardiography (TEE). Furthermore we will compare routine
hemodynamic monitoring (i.e. mean arterial pressure, heart rate, cardiac index,
and systemic vascular resistance index). Incidence of new onset atrial
fibrillation will also be monitored.
Background 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 our institution, 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 we 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).
Study objective
The aim of this study is to determine whether the addition of adenosine to
standard intermittent warm blood cardioplegia reduces the 6-hours
post-operative cTnT in patients scheduled for minimally invasive, port access
operations (mitral valve surgery).
Study design
Single center, randomized double-blind placebo-controlled trial.
Intervention
during cardiopulmonary bypass one group receives standard cardioplegic solution
(control), the second group receives cardioplegic solution enriched with
adenosine (intervention). To maintain cardioplegic arrest, a maintenance dose
of cardioplegic solution is given every 20 minutes.
Study burden and risks
As patients are on cardiopulmonary bypass during surgery and biological
elimination half-life of adenosine is very short (< 10 seconds), application of
adenosine during cardioplegia imposes no increased risk in our patients. The
number of blood samples, the number of site visits and other examinations are
equal in all groups. No additional tests will be performed as in standard care.
Molengracht 21
Breda 4800RK
NL
Molengracht 21
Breda 4800RK
NL
Listed location countries
Age
Inclusion criteria
* Gender; male/ female
* Age: * 18 year
*Elective cardiac surgical patients: - minimally invasive, port-access surgery (mitral valve surgery)
Exclusion criteria
Other types of cardiac surgery patients
Theophylline or dipyridamole use up to 24 hours prior to surgery
Caffeine use up to 12 hours prior to surgery
Other xantthine derivatives
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR 2015-001923-2-NL |
| CCMO | NL53469.015.15 |