Trials / Completed
CompletedNCT03500783
Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
- Sex
- All
- Age
- 56 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Coronary Artery Disease
- Coronary Artery Bypass
- Cardiopulmonary Bypass
- Nitric Oxide
- Reperfusion Injury, Myocardial
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nitric Oxide | 40 ppm of exogenous gaseous nitric oxide is supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting. |
| OTHER | Standard CPB | Standard protocol of delivery of air gas mixture to the cardiopulmonary bypass circuit |
Timeline
- Start date
- 2015-05-15
- Primary completion
- 2016-11-30
- Completion
- 2016-11-30
- First posted
- 2018-04-18
- Last updated
- 2019-07-05
Source: ClinicalTrials.gov record NCT03500783. Inclusion in this directory is not an endorsement.