CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2 enrolled
Drug / intervention
Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06373549
NCT06373549N/ACompleted

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

Tamer cebe·observational·Posted Apr 18, 2024·Updated Apr 18, 2024

In Brief

An observational study evaluating Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions and Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions for Cardiovascular Diseases and Myocardial Reperfusion Injury. Completed, enrolled 2 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 18, 2024
Enrollment StartDec 8, 2022
Primary CompletionJul 24, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.2 years ago

Interventions

Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutionsprocedure

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 routine procedural administration of cardioplegia solutionsprocedure

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.