Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-15

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery

NCT03527381

Coronary Artery Disease Heart Valve Diseases Cardiomyopathies +1 more

COMPLETED PHASE1/PHASE2

Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass

NCT06702553

Nitric Oxide Cardiac Surgery Cardiopulmonary Bypass +1 more

RECRUITING PHASE3

Nitric Oxide During Cardiopulmonary Bypass in Adult Surgery

NCT04807413

Hypoxia

UNKNOWN PHASE3

Effects of Hypoxic-hyperoxic Preconditioning in Cardio-surgical Patients

NCT05354648

Myocardial Reperfusion Injury Hypoxia Hyperoxia +1 more

COMPLETED NA

Prevention of Renal Failure by Nitric Oxide in Prolonged Cardiopulmonary Bypass.

NCT01802619

Heart Valve Diseases Heart; Complications, Valve, Prosthesis Cardiac Valve Replacement Complication

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center prospective, randomized, placebo-controlled study

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Trial participants, data analysts, and report writers are blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nitric Oxide

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.

Group Type EXPERIMENTAL

Nitric Oxide

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Standard CPB

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Standard CPB

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cardiopulmonary bypass

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

56 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No