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Investigation of Myocardial Protection Level With Specific Cardioplegia Methods in Cardiac Surgery

D

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Status

Completed

Conditions

Coronary Artery Disease
Aortic Valve Stenosis
Bypass Complication
Endothelial Degeneration
Cardioplegia Solution Adverse Reaction
Oxidative Stress

Treatments

Diagnostic Test: Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status

Study type

Observational

Funder types

Other

Identifiers

NCT05603429
HNEAH-KAEK 2022/43-3507

Details and patient eligibility

About

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.

Full 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

Enrollment

74 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

74 participants in 4 patient groups

CABG with cold blood cardioplegia
Description:
Subjects undergo Elective Coronary Artery Bypass Grafting with the use of cold blood cardioplegia solution for myocardial protection
Treatment:
Diagnostic Test: Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status
CABG with Del Nido
Description:
Subjects undergo Elective Coronary Artery Bypass Grafting with the use of Del Nido cardioplegia solution as myocardial protection
Treatment:
Diagnostic Test: Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status
AVR with cold blood cardioplegia
Description:
Subjects undergo Aortic Valve Replacement with the use of cold blood cardioplegia solution as myocardial protection
Treatment:
Diagnostic Test: Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status
AVR with Del Nido
Description:
Subjects undergo Aortic Valve Replacement with the use of Del Nido cardioplegia solution as myocardial protection
Treatment:
Diagnostic Test: Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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