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

NCT ID: NCT05603429

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-13

Study Completion Date

2023-08-08

Brief Summary

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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

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CABG with cold blood cardioplegia

Subjects undergo Elective Coronary Artery Bypass Grafting with the use of cold blood cardioplegia solution for myocardial protection

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

Intervention Type DIAGNOSTIC_TEST

Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress

CABG with Del Nido

Subjects undergo Elective Coronary Artery Bypass Grafting with the use of Del Nido cardioplegia solution as myocardial protection

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

Intervention Type DIAGNOSTIC_TEST

Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress

AVR with cold blood cardioplegia

Subjects undergo Aortic Valve Replacement with the use of cold blood cardioplegia solution as myocardial protection

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

Intervention Type DIAGNOSTIC_TEST

Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress

AVR with Del Nido

Subjects undergo Aortic Valve Replacement with the use of Del Nido cardioplegia solution as myocardial protection

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

Intervention Type DIAGNOSTIC_TEST

Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress

Interventions

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

Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Fatih KIZILYEL

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bulend KETENCI

Role: STUDY_CHAIR

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

Locations

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Dr. Siyami Ersek Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28863040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20656301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29246552 (View on PubMed)

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.

Reference Type RESULT
PMID: 33118734 (View on PubMed)

Other Identifiers

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HNEAH-KAEK 2022/43-3507

Identifier Type: -

Identifier Source: org_study_id

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