Investigation of Myocardial Protection Efficacy of Cardioplegia Solutions Used in Open Heart Surgery

April 17, 2024 updated by: Tamer cebe

Investigation of the Protective Effects of Cardioplegia Solutions Used in Open Heart Surgery on Myocardial Redox Homeostasis at the Level of Redox System and Antioxidant System

Cardioplegias are different pharmacokinetic solutions routinely used in cardiac surgery to protect the heart from ischemia and induce arrest. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are used in clinical practice. There is no clear scientific data in the literature that demonstrates the superiority of one cardioplegia over the others. The choice of the appropriate cardioplegia depends on the surgeon's clinical experience and preference. In this study preferred the blood cardioplegia and del Nido cardioplegia, which are commonly used in clinic. Both cardioplegias have different advantages that contribute to their preference in clinical practice.

Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals. The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. In addition to these different usage scenarios, the myocardial protective effects of cardioplegias on cellular redox homeostasis are also among the current research topics. Thesis project can contribute to the current literature and clinical practice on the cardioprotective advantages of cardioplegia solutions and the reasons for their preference in surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cardioplegias are routinely used in cardiac surgery to protect the heart from ischemia. Choice of the cardioplegia depends on surgeons clinical experience and preference. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are widely used in clinical practice. There is no clear scientific data in the current literature that demonstrates the superiority of one cardioplegia over the others.

In this study preferred the blood and del Nido cardioplegia solutions, which are commonly used in clinic. Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals.

The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. Hamad et al reported that del Nido and blood cardioplegia solutions offer equivalent safety in combined adult valve surgery. In addition to these differences, the myocardial protective effects of cardioplegias on myocardial redox homeostasis are also among the current research topics. Ischemia and reperfusion injury can be observed in the myocardial tissues of patients undergoing coronary artery bypass graft surgery and isolated valve replacement surgery. It was reported that coronary sinus blood sampling gives an insight into the localized pathophysiology of heart diseases. Comparative research examining the effects of blood and del Nido cardioplegia solutions on coronary sinus redox status is not currently available in the literature. The study aim to contribute to the development of effective strategies to minimize oxidative damage associated with cardiac surgery by investigating the effects of blood and del Nido cardioplegia solutions on coronary sinus redox homeostasis during the preoperative and postoperative periods using redox biomarkers and antioxidant system transcription factors. Thesis project also intend to compare these redox effects with elective isolated valve replacement surgery patients, who do not have coronary artery disease but share a similar pathogenesis with potential strategies for minimizing oxidative damage associated with cardiac surgery using cardiopulmonary bypass (CPB).

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kadıköy
      • Istanbul, Kadıköy, Turkey, 34668
        • SBÜ. Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi Erişkin Kalp ve Damar Cerrahisi Kliniği

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Adult Cardiovascular Surgery Clinic will be selected among the patients who will undergo cardiac surgery and meet the inclusion criteria.

Description

Inclusion Criteria:

  • Patients who underwent elective coronary artery bypass surgery due to coronary artery disease
  • Patients without coronary artery disease who underwent elective valve surgery
  • Patients between the ages of 18-75
  • Having a BMI of 18.5-30

Exclusion Criteria:

  • Being under 18 years old
  • Patients older than 75 years
  • Patients requiring valve surgery (combined surgical procedure) with coronary artery bypass
  • Patients who underwent emergency coronary bypass
  • BMI > 30 obese patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with coronary artery bypass surgery due to coronary artery disease
From the patients included in the study, blood samples will be taken from the systemic venous circulation before the operation, and from the coronary sinus at 4 minutes before and after the cross-clamp, via a retrograde cardioplegia cannula into yellow capped gel tubes.
Procedure: Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions
To investigate the effectiveness of myocardial protection methods, blood samples were collected from the coronary sinus before the aortic cross-clamping and at 4 minutes after aortic cross-clamping, through a coronary sinus cannula with a yellow-capped gel tube. The collected blood samples were kept in an upright position for 20 minutes to allow separation into serum fraction, then centrifuged at 3000 g for 10 minutes (Beckman Coulter, Microfuge 16, USA). The obtained serums were aliquoted into 250 μl portions in Eppendorf tubes, separately for each patient.
Procedure: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions
To investigate the effectiveness of myocardial protection methods, blood samples were collected from the coronary sinus before the aortic cross-clamping and at 4 minutes after aortic cross-clamping, through a coronary sinus cannula with a yellow-capped gel tube. The collected blood samples were kept in an upright position for 20 minutes to allow separation into serum fraction, then centrifuged at 3000 g for 10 minutes (Beckman Coulter, Microfuge 16, USA). The obtained serums were aliquoted into 250 μl portions in Eppendorf tubes, separately for each patient.
Patients who underwent heart valve surgery without coronary artery disease
From the patients included in the study, blood samples will be taken from the systemic venous circulation before the operation, and from the coronary sinus at 4 minutes before and after the cross-clamp, via a retrograde cardioplegia cannula into yellow capped gel tubes.
Procedure: Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions
To investigate the effectiveness of myocardial protection methods, blood samples were collected from the coronary sinus before the aortic cross-clamping and at 4 minutes after aortic cross-clamping, through a coronary sinus cannula with a yellow-capped gel tube. The collected blood samples were kept in an upright position for 20 minutes to allow separation into serum fraction, then centrifuged at 3000 g for 10 minutes (Beckman Coulter, Microfuge 16, USA). The obtained serums were aliquoted into 250 μl portions in Eppendorf tubes, separately for each patient.
Procedure: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions
To investigate the effectiveness of myocardial protection methods, blood samples were collected from the coronary sinus before the aortic cross-clamping and at 4 minutes after aortic cross-clamping, through a coronary sinus cannula with a yellow-capped gel tube. The collected blood samples were kept in an upright position for 20 minutes to allow separation into serum fraction, then centrifuged at 3000 g for 10 minutes (Beckman Coulter, Microfuge 16, USA). The obtained serums were aliquoted into 250 μl portions in Eppendorf tubes, separately for each patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the myocardial protective effects of different cardioplegia solutions through oxidative stress and redox signaling molecules.
Time Frame: 1-7 days

The PCO concentration was expressed as nmol/mg protein. The standard curve was used to express the AOPP concentrations as micromoles per liter of chloramine-T equivalents.Lipid peroxidation rate of coronary sinus blood samples was assessed with a calibration curve for peroxide value using xylenol orange and Fe3+ chloride.

Mitochondrial superoxide dismutase expression.MnSOD concentrations of the coronary sinus blood samples were expressed as ng/mL.GPx activities of the coronary sinus blood samples were expressed as U/mg protein.The CAT activity is measured as the difference in absorbance per unit time.CAT concentrations of the coronary sinus blood samples were expressed as KU/L.The serum Nrf2 levels of the samples were expressed as ng/L.The serum Keap1 levels of the samples were expressed as ng/L.The samples' serum PGC-1α levels were reported as ng/mL.
1-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tamer cebe

Collaborators

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2022

Primary Completion (Actual)

July 24, 2023

Study Completion (Actual)

July 24, 2023

Study Registration Dates

First Submitted

February 10, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/183-3896

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

During the process of obtaining informed consent from the participants involved in the study, it was stated that their data would not be used elsewhere.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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