The effect of Adenosine on Myocardial Protection in Intermittent warm blood Cardioplegia: a randomized placebo-controlled trial
Phase 2
Completed
- Conditions
- Heart diseases (minimally invasiveport access operations (mitral valve surgery))10046973
- Registration Number
- NL-OMON42535
- Lead Sponsor
- Amphia Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>the main study parameter is 6 hours post-operative cTnT. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are differences in 18-hour postoperative cTnT levels as<br /><br>determined by the area-under-the-curve (AUC), differences in pre- and<br /><br>post-operative creatine kinase-MB (CK-MB) levels, inotrope usage and dosage,<br /><br>and differences in pre- and postoperative left ventricular ejection fraction<br /><br>(LVEF) and wall motion score index (WMSI) determined by 3-dimensional<br /><br>transesophageal echocardiography (TEE). Furthermore we will compare routine<br /><br>hemodynamic monitoring (i.e. mean arterial pressure, heart rate, cardiac index,<br /><br>and systemic vascular resistance index). Incidence of new onset atrial<br /><br>fibrillation will also be monitored.</p><br>