Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass (NOinCPB)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Coronary Artery Disease; Reperfusion Injury, Myocardial; Cardiopulmonary Bypass; Nitric Oxide; Coronary Artery Bypass

Treatments: Drug: Nitric Oxide; Other: Standard CPB

Study type: Interventional

Funder types: Other

Identifiers

NCT03500783

NOinCPB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 56 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Nitric Oxide

Experimental group

Description:

Patients of this group receive treatment with exogenous gaseous nitric oxide supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting for coronary artery disease.

Treatment:

Drug: Nitric Oxide

Standard CPB

Placebo Comparator group

Description:

Patients of this group receive sham-treatment without supplying nitric oxide to the cardiopulmonary bypass circuit during coronary artery bypass grafting for coronary artery disease. Considering dilution of nitric oxide at a high ratio of 1 to 25,000 in the gas mixture of the cardiopulmonary bypass circuit (CPB), no addition of any inert gas to the CPB circuit is required in sham-treatment group.

Treatment:

Other: Standard CPB