Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass

Coronary Artery Disease Clinical Trial

— NOinCPB  

Official title:

Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500783
• Other study ID #: NOinCPB
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 15, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: July 2019
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 56 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Coronary Artery Bypass
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Myocardial Reperfusion Injury
• Nitric Oxide
• Reperfusion Injury
• Reperfusion Injury, Myocardial

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac troponin I change measure (cTnI)	Changes in the plasma level of cTnI (ng/mL) relative to the baseline value are measured at 6, 24, and 48 hours after surgery.	48 hours (with intermediate measurements at 6 and 24 hours)
Secondary	Creatine kinase-muscle/brain change measure (CK-MB)	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.	48 hours (with intermediate measurements at 6 and 24 hours)
Secondary	Vasoactive inotropic score measure (VIS)	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).	48 hours (with intermediate measurements at 6 and 24 hours)