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Completed

NCT Number: NCT03500783

Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nitric oxide

Drug

40 ppm of exogenous gaseous nitric oxide is supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting.

Standard CPB

Other

Standard protocol of delivery of air gas mixture to the cardiopulmonary bypass circuit

Other names: Cardiopulmonary bypass

Primary outcomes

  1. Cardiac troponin I change measure (cTnI)

    Time frame: 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 outcomes

  1. Creatine kinase-muscle/brain change measure (CK-MB)

    Time frame: 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.

  2. Vasoactive inotropic score measure (VIS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Acronym: NOinCPB

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 18, 2018
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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