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

Primary Purpose

Coronary Artery Disease, Coronary Artery Bypass, Cardiopulmonary Bypass

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nitric Oxide
Standard CPB
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Cardioprotection, Ischemia-reperfusion injury, Nitric oxide, Cardiopulmonary bypass, Coronary artery bypass grafting

Eligibility Criteria

56 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Nitric Oxide

    Standard CPB

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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).

    Full Information

    First Posted
    April 3, 2018
    Last Updated
    July 1, 2019
    Sponsor
    Tomsk National Research Medical Center of the Russian Academy of Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03500783
    Brief Title
    Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass
    Acronym
    NOinCPB
    Official Title
    Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 15, 2015 (Actual)
    Primary Completion Date
    November 30, 2016 (Actual)
    Study Completion Date
    November 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tomsk National Research Medical Center of the Russian Academy of Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Coronary Artery Bypass, Cardiopulmonary Bypass, Nitric Oxide, Reperfusion Injury, Myocardial
    Keywords
    Cardioprotection, Ischemia-reperfusion injury, Nitric oxide, Cardiopulmonary bypass, Coronary artery bypass grafting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Single-center prospective, randomized, placebo-controlled study
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Trial participants, data analysts, and report writers are blinded.
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nitric Oxide
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Standard CPB
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Nitric Oxide
    Intervention Description
    40 ppm of exogenous gaseous nitric oxide is supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting.
    Intervention Type
    Other
    Intervention Name(s)
    Standard CPB
    Other Intervention Name(s)
    Cardiopulmonary bypass
    Intervention Description
    Standard protocol of delivery of air gas mixture to the cardiopulmonary bypass circuit
    Primary Outcome Measure Information:
    Title
    Cardiac troponin I change measure (cTnI)
    Description
    Changes in the plasma level of cTnI (ng/mL) relative to the baseline value are measured at 6, 24, and 48 hours after surgery.
    Time Frame
    48 hours (with intermediate measurements at 6 and 24 hours)
    Secondary Outcome Measure Information:
    Title
    Creatine kinase-muscle/brain change measure (CK-MB)
    Description
    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.
    Time Frame
    48 hours (with intermediate measurements at 6 and 24 hours)
    Title
    Vasoactive inotropic score measure (VIS)
    Description
    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).
    Time Frame
    48 hours (with intermediate measurements at 6 and 24 hours)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    56 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sergey V Popov, MD
    Organizational Affiliation
    Tomsk NRMC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
    IPD Sharing Time Frame
    Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
    IPD Sharing Access Criteria
    Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

    Learn more about this trial

    Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass

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