Clinical trial NCT05603429: Investigation of Myocardial Protection Level With Specific Cardioplegia Methods in Cardiac Surgery
Official title: Investigation of Myocardial Protection Level by Oxidative Stress and Endothelial Damage With Two Cardioplegia Methods Used During Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bypass Complication
Cardioplegia Solution Adverse Reaction
Endothelial Degeneration
Oxidative Stress
Aortic Valve Stenosis
Coronary Artery Disease
Keywords: Coronary Artery Bypass Grafting
Cardioplegia
Cardiopulmonary Bypass
Aortic Valve Replacement
Endothelial Damage
Oxidative Stress
Lead sponsor: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with coronary artery disease and aortic valve stenosis irrespectively

Brief summary: Investigating the myocardial effects of cold blood cardioplegia and del nido cardioplegia solution, which are routinely used in clinical practice, will contribute to the studies in the literature on the safety and efficacy of these two methods.

For this purpose, patients with coronary artery disease that going to be Coronary Artery Bypass Graft (CABG) surgery will be classified within the scope of the SYNTAX score, the level of exposure to cardioplegia change in proportion to their score will be examined. Also, left ventricular muscle mass will be calculated in patients who will undergo Aortic Valve replacement (AVR) due to Aortic Stenosis, and myocardial protection level proportional to muscle mass will be examined, and cardioplegia efficiency will be compared.

Detailed description: Endocan, E-Selectin, TNF(Tumor Necrosis Factor)-alpha, Total Oxidant and Antioxidant status will be studied on sequential blood samples taken from patients who will undergo Elective Coronary Artery Bypass Grafting operation and aortic valve replacement, via retrograde cardioplegia cannula before induction, at the beginning of cardiopulmonary bypass and after removing the cross-clamp. With routinely used parameters like hemogram, lactate, liver and kidney function tests morbidity-mortality rates for specific cardioplegia technique will be compared

Eligibility criteria: Inclusion Criteria:

* Subjects planned to have elective coronary artery bypass grafting for coronary artery disease
* Subjects planned to have elective aortic valve surgery due to aortic valve stenosis
* Patients aged 18-75 years
* BMI of 18.5-30
* Diabetic and non-diabetic patients
* Smokers and non-smokers

Exclusion Criteria:

* Subjects under 18 years old
* Subjects older than 75 years
* Patients requiring valve surgery with coronary artery bypass
* Patients requiring aortic valve surgery with pathologies other than aortic valve stenosis
* Patients requiring mitral or tricuspid valve surgery
* Patients undergoing emergency coronary bypass
* BMI \> 30 obese patients

Primary outcomes:
measure: Del Nido has beneficial effect for Endothelial function
timeFrame: through study completion, an average of 1 year
measure: Del Nido cardioplegia solution has lesser oxidative effect comparing to blood cardioplegia
timeFrame: through study completion, an average of 1 year
measure: SYNTAX effect (SYNergy between PCI{Percutaneous Coronary Intervention} with TAXUS and Cardiac. Surgery)
timeFrame: through study completion, an average of 1 year
measure: LVMI effect
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dr. Siyami Ersek Hospital
Study officials:
affiliation: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Bulend KETENCI
role: STUDY_CHAIR
References:
citation: Li Y, Lin H, Zhao Y, Li Z, Liu D, Wu X, Ji B, Gao B. Del Nido Cardioplegia for Myocardial Protection in Adult Cardiac Surgery: A Systematic Review and Meta-Analysis. ASAIO J. 2018 May/Jun;64(3):360-367. doi: 10.1097/MAT.0000000000000652.
citation: O'Blenes SB, Friesen CH, Ali A, Howlett S. Protecting the aged heart during cardiac surgery: the potential benefits of del Nido cardioplegia. J Thorac Cardiovasc Surg. 2011 Mar;141(3):762-70. doi: 10.1016/j.jtcvs.2010.06.004. Epub 2010 Jul 24.
citation: Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13.
citation: Orak Y, Kocarslan A, Boran OF, Acipayam M, Eroglu E, Kirisci M, Doganer A. Comparison of the operative and postoperative effects of del Nido and blood cardioplegia solutions in cardiopulmonary bypass surgery. Braz J Cardiovasc Surg. 2020 Oct 1;35(5):689-696. doi: 10.21470/1678-9741-2019-0436.