Cardiopulmonary Bypass, Coronary Artery Bypass, Coronary Artery Disease, Nitric Oxide, Reperfusion Injury, Myocardial
Conditions
Keywords
Cardioprotection, Ischemia-reperfusion injury, Nitric oxide, Cardiopulmonary bypass, Coronary artery bypass grafting
Brief summary
This prospective randomized study elucidates the effects of exogenous nitric oxide delivered to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion injury during coronary artery bypass graft surgery with cardiopulmonary bypass.
Detailed description
The aim of this study is to investigate the effects of exogenous nitric oxide (NO) delivered to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion injury during coronary artery bypass graft surgery (CABG) with cardiopulmonary bypass (CPB). A total of 60 patients with ischemic heart disease referred for CABG with CPB are included in prospective randomized study. Patients are randomized to receive standard treatment or surgery based on modified CPB protocol. According to modified protocol, 40-ppm NO is supplied to the CPB circuit during CABG. The primary endpoints are changes in cardiac troponin I (cTnI) levels at 6, 24, and 48 hours after surgery compared with baseline. The secondary end points are the changes in the levels of creatine kinase-muscle/brain (CK-MB) compared with baseline and vasoactive inotropic score (VIS) at 6, 24, and 48 hours. NO supplied to the CPB circuit exertes cardioprotective effect. Changes in cTnI, CK-MB, and VIS are considered indictors of the presence or absence of cardioprotective action of NO supplied to the CPB circuit.
Interventions
DRUGNitric Oxide
40 ppm of exogenous gaseous nitric oxide is supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting.
OTHERStandard CPB
Standard protocol of delivery of air gas mixture to the cardiopulmonary bypass circuit
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Trial participants, data analysts, and report writers are blinded.
Intervention model description
Single-center prospective, randomized, placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
56 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Coronary artery disease requiring coronary artery bypass grafting with the cardiopulmonary bypass.
Exclusion criteria
* Non-elective surgery, age over 70 years, left ventricular ejection fraction less than 35%, history of myocardial infarction within three months prior to surgery, chronic atrial fibrillation, diabetes mellitus, and the elevated levels of cardiac specific markers within 12 h prior to the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac troponin I change measure (cTnI) | 48 hours (with intermediate measurements at 6 and 24 hours) | Changes in the plasma level of cTnI (ng/mL) relative to the baseline value are measured at 6, 24, and 48 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatine kinase-muscle/brain change measure (CK-MB) | 48 hours (with intermediate measurements at 6 and 24 hours) | Changes in the plasma level of CK-MB (U/L) relative to the baseline value are measured at 6, 24, and 48 hours after surgery. |
| Vasoactive inotropic score measure (VIS) | 48 hours (with intermediate measurements at 6 and 24 hours) | Vasoactive inotropic score (VIS) is assessed at 6, 24, and 48 hours after surgery. VIS is calculated as follows: (dobutamine μg/kg/min × 1 + dopamine μg/kg/min × 1 + milrinone μg/kg/min × 10) + 100 × (adrenalin μg/kg/min + noradrenaline μg/kg/min + vasopressin μg/kg/min). |
Outcome results
None listed