Clinical trial NCT02681913: Adenosine as an Adjunct to Blood Cardioplegia
Official title: The Effect of Adenosine on Myocardial Protection in Intermittent Warm Blood Cardioplegia: A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pathological Processes
Cardiomyopathies
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)
Lead sponsor: Amphia Hospital
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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)

Primary outcomes:
measure: 6-hour cardiac Troponin T (cTnT) release
timeFrame: 6 hours post-operative
Secondary outcomes:
measure: 18-hour cardiac Troponin T (cTnT) area under the curve (AUC) release
timeFrame: cardiac Troponin T (cTnT) AUC will be assessed at different time points, the latest up to 18 hours after ICU arrival
measure: Incidence of myocardial injury on 12-lead ECG
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 2 days
measure: Vasoactive-inotropic score
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 2 days
measure: Vasoconstrictor usage
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 2 days
measure: Incidence of new onset Atrial fibrillation (AF)
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 2 days
measure: Routine blood samples
timeFrame: Routine blood samples will be assessed at different time points, the latest up to 6 hours after ICU arrival
measure: Mean arterial pressure (MAP)
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 2 days
measure: postoperative left ventricular ejection fraction (LVEF)
timeFrame: postoperative after skin closure, an expected average of 3 hours after starting surgery
measure: Wall Motion Score Index (WMSI)
timeFrame: postoperative after skin closure, an expected average of 3 hours after starting surgery
measure: Heart rate (HR)
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 2 days
measure: Cardiac index (CI)
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 2 days
measure: Systemic vascular resistance index (SVRI)
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 2 days
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia Hospital
state: Noord-Brabant
Study officials:
affiliation: Amphia Hospital
name: Jeffrey Engelhart, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.
citation: Liu R, Xing J, Miao N, Li W, Liu W, Lai YQ, Luo Y, Ji B. The myocardial protective effect of adenosine as an adjunct to intermittent blood cardioplegia during open heart surgery. Eur J Cardiothorac Surg. 2009 Dec;36(6):1018-23. doi: 10.1016/j.ejcts.2009.06.033. Epub 2009 Aug 15.