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

NCT06373549 | Completed

• 1 other identifier: 2022/183-3896
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Myocardial Reperfusion Injury

Keywords

cardioplegia; del Nido; open heart surgery; oxidative stress; redox status

Outcome Measures

Primary Outcomes (1)

• Evaluation of the myocardial protective effects of different cardioplegia solutions through oxidative stress and redox signaling molecules.

  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

Study Arms (2)

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; Procedure: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions

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; Procedure: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions

Interventions

Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions PROCEDURE

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; Patients with coronary artery bypass surgery due to coronary artery disease

Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions PROCEDURE

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; Patients with coronary artery bypass surgery due to coronary artery disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tamer cebe: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

SBÜ. Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi Erişkin Kalp ve Damar Cerrahisi Kliniği

Istanbul, Kadıköy, 34668, Turkey (Türkiye)

Location

Related Publications (10)

• Carvajal C, Goyal A, Tadi P. Cardioplegia. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554463/

  PMID: 32119350 BACKGROUND

• Comentale G, Giordano R, Palma G. Comparison of the different cardioplegic strategies in cardiac valves surgery: who wins the "arm-wrestling"? J Thorac Dis. 2018 Feb;10(2):714-717. doi: 10.21037/jtd.2018.01.133. No abstract available.

  PMID: 29607140 BACKGROUND

• Weber C, Jenke A, Chobanova V, Yazdanyar M, Chekhoeva A, Eghbalzadeh K, Lichtenberg A, Wahlers T, Akhyari P, Paunel-Gorgulu A. Targeting of cell-free DNA by DNase I diminishes endothelial dysfunction and inflammation in a rat model of cardiopulmonary bypass. Sci Rep. 2019 Dec 17;9(1):19249. doi: 10.1038/s41598-019-55863-8.

  PMID: 31848423 BACKGROUND

• Atayik MC, Cakatay U. Redox signaling and modulation in ageing. Biogerontology. 2023 Oct;24(5):603-608. doi: 10.1007/s10522-023-10055-w. Epub 2023 Aug 3.

  PMID: 37535201 BACKGROUND

• Ulasov AV, Rosenkranz AA, Georgiev GP, Sobolev AS. Nrf2/Keap1/ARE signaling: Towards specific regulation. Life Sci. 2022 Feb 15;291:120111. doi: 10.1016/j.lfs.2021.120111. Epub 2021 Oct 31.

  PMID: 34732330 BACKGROUND

• Calabrese EJ, Kozumbo WJ. The hormetic dose-response mechanism: Nrf2 activation. Pharmacol Res. 2021 May;167:105526. doi: 10.1016/j.phrs.2021.105526. Epub 2021 Mar 2.

  PMID: 33667690 BACKGROUND

• GIBBON JH Jr. Application of a mechanical heart and lung apparatus to cardiac surgery. Minn Med. 1954 Mar;37(3):171-85; passim. No abstract available.

  PMID: 13154149 BACKGROUND

• Topcu AC, Bolukcu A, Ozeren K, Kavasoglu T, Kayacioglu I. Normoxic management of cardiopulmonary bypass reduces myocardial oxidative stress in adult patients undergoing coronary artery bypass graft surgery. Perfusion. 2021 Apr;36(3):261-268. doi: 10.1177/0267659120946733. Epub 2020 Aug 5.

  PMID: 32755372 BACKGROUND

• Cebe T, Yanar K, Atukeren P, Ozan T, Kuruc AI, Kunbaz A, Sitar ME, Mengi M, Aydin MS, Esrefoglu M, Aydin S, Cakatay U. A comprehensive study of myocardial redox homeostasis in naturally and mimetically aged rats. Age (Dordr). 2014;36(6):9728. doi: 10.1007/s11357-014-9728-y. Epub 2014 Nov 11.

  PMID: 25384832 BACKGROUND

• Cebe T, Atukeren P, Yanar K, Kuruc AI, Ozan T, Kunbaz A, Sitar ME, Mirmaroufizibandeh R, Aydin S, Cakatay U. Oxidation scrutiny in persuaded aging and chronological aging at systemic redox homeostasis level. Exp Gerontol. 2014 Sep;57:132-40. doi: 10.1016/j.exger.2014.05.017. Epub 2014 May 28.

  PMID: 24879971 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Myocardial Reperfusion Injury

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asistant Doctor

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: April 18, 2024
• Study Start: December 8, 2022
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)