Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287372
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2024-02-23
Brief Title:
Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegia
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegic Solutions in Routine Coronary Artery Bypass Surgery
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the present study was to investigate intra-operative changes in markers of myocardial injury and myocardial intracellular amino acids during ischemia and reperfusion comparing two methods of myocardial protection Calafiore intermittent antegrade warm blood cardioplegia or modified del Nido intermittent antegrade cold blood cardioplegia in routine coronary artery bypass grafting procedures
Detailed Description:
Twenty consecutive patients undergoing elective primary coronary artery bypass grafting were enrolled in this study Patients were excluded from this study if they had suffered from previous myocardial infarction had reduced ejection fraction or were undergoing combined or repeated surgery Patients were randomly assigned to undergo surgery using one of two methods for myocardial protection
Group 1 Calafiore intermittent antegrade warm blood cardioplegia consisting of normothermic pump blood potassium chloride 2 mEqml and magnesium sulfate 50 This cardioplegic solution was administered at 37 degrees C following application of the aortic cross-clamp and repeated after completion of each distal coronary anastomosis as described previously
Group 2 Modified del Nido intermittent antegrade cold blood cardioplegic solution consisting of 750 ml of lactated Ringer solution 200 ml of pump blood 13 ml of sodium bicarbonate 84 16 ml of mannitol 20 4 ml of magnesium sulfate 50 13 ml of lidocaine 2 and 13 ml of potassium chloride 2 mEqml This solution was administered as a 1-liter bolus at 3-4 degrees C following application of the aortic cross-clamp and repeated as a 500 ml bolus if cross-clamp time extended beyond 60 minutes none of the patients in this study
Each patient enrolled in the study gave a written informed consent for the publication of the study data and the study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the local human research committee number 171 dated 13 April 2022
Collection of blood samples and myocardial biopsies Peripheral blood samples were collected immediately prior to surgery and at 4 12 24 and 48 hours postoperatively and were used for determination of blood concentrations of cardiac enzymes CK-MB and troponin I
Myocardial biopsies 4-14 mg wet weight were taken using a Tru-cut needle from the apex of the left ventricle in every patient as follows
Biopsy 1 Resting specimen immediately after beginning of extracorporeal circulation
Biopsy 2 Ischemic specimen 30 minutes after application of the aortic cross-clamp
Biopsy 3 Reperfusion specimen 20 minutes following the removal of aortic cross-clamp
Each specimen was immediately snap-frozen in liquid nitrogen -185 degrees C until processing for the analyses of amino acids and lactic acid
Determination of cardiac enzymes CK-MB and troponin I Analyses were carried out using an immunofluorescence scanner iChroma II Boditech Med Incorporated Korea and Obelis sa Belgium Blood levels of CK-MB were expressed as mgdl and levels of troponin I were expressed as ngml
Determination of myocardial amino acid and lactic acid concentrations Each frozen biopsy specimen was weighed Laboratory Analytical Balance Sartorius Germany crushed in liquid nitrogen and homogenized in 1000 micro mol of 09 normal saline A 400 micro mol sample of the homogenate was transferred to an Eppendorf tube and 100 micro mol of HPLC water was added Each sample was then stored at 4 degrees C for one hour after which it was centrifuged at 10000 roundmin for 5 minutes A 400 micro mol sample of the supernatant was filtered through a Vivaspin 500 membrane filter 02 µm Satorius Germany transferred to an Eppendorf tube and was centrifuged at 10000 roundmin for 5 minutes A 300 micro mol sample of the filtrate was transferred to an Eppendorf tube and an equal volume of sample dilution buffer membraPure Germany was added This solution was used for determining the concentrations of 7 amino acids alanine glutamine glutamic acid glycine lysine ornithine and taurine using the A300 Amino Acid Analyzer ARACUS membraPure Germany Lactic acid concentrations were also measured using a dedicated plasma lactate determination kit and analyzer LACT2 cobas Roche Diagnostics GmbH Germany Concentrations of amino acids and lactic acid were expressed as micro molg wet weight
Group 1 Calafiore intermittent antegrade warm blood cardioplegia consisting of normothermic pump blood potassium chloride 2 mEqml and magnesium sulfate 50 This cardioplegic solution was administered at 37 degrees C following application of the aortic cross-clamp and repeated after completion of each distal coronary anastomosis as described previously
Group 2 Modified del Nido intermittent antegrade cold blood cardioplegic solution consisting of 750 ml of lactated Ringer solution 200 ml of pump blood 13 ml of sodium bicarbonate 84 16 ml of mannitol 20 4 ml of magnesium sulfate 50 13 ml of lidocaine 2 and 13 ml of potassium chloride 2 mEqml This solution was administered as a 1-liter bolus at 3-4 degrees C following application of the aortic cross-clamp and repeated as a 500 ml bolus if cross-clamp time extended beyond 60 minutes none of the patients in this study
Each patient enrolled in the study gave a written informed consent for the publication of the study data and the study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the local human research committee number 171 dated 13 April 2022
Collection of blood samples and myocardial biopsies Peripheral blood samples were collected immediately prior to surgery and at 4 12 24 and 48 hours postoperatively and were used for determination of blood concentrations of cardiac enzymes CK-MB and troponin I
Myocardial biopsies 4-14 mg wet weight were taken using a Tru-cut needle from the apex of the left ventricle in every patient as follows
Biopsy 1 Resting specimen immediately after beginning of extracorporeal circulation
Biopsy 2 Ischemic specimen 30 minutes after application of the aortic cross-clamp
Biopsy 3 Reperfusion specimen 20 minutes following the removal of aortic cross-clamp
Each specimen was immediately snap-frozen in liquid nitrogen -185 degrees C until processing for the analyses of amino acids and lactic acid
Determination of cardiac enzymes CK-MB and troponin I Analyses were carried out using an immunofluorescence scanner iChroma II Boditech Med Incorporated Korea and Obelis sa Belgium Blood levels of CK-MB were expressed as mgdl and levels of troponin I were expressed as ngml
Determination of myocardial amino acid and lactic acid concentrations Each frozen biopsy specimen was weighed Laboratory Analytical Balance Sartorius Germany crushed in liquid nitrogen and homogenized in 1000 micro mol of 09 normal saline A 400 micro mol sample of the homogenate was transferred to an Eppendorf tube and 100 micro mol of HPLC water was added Each sample was then stored at 4 degrees C for one hour after which it was centrifuged at 10000 roundmin for 5 minutes A 400 micro mol sample of the supernatant was filtered through a Vivaspin 500 membrane filter 02 µm Satorius Germany transferred to an Eppendorf tube and was centrifuged at 10000 roundmin for 5 minutes A 300 micro mol sample of the filtrate was transferred to an Eppendorf tube and an equal volume of sample dilution buffer membraPure Germany was added This solution was used for determining the concentrations of 7 amino acids alanine glutamine glutamic acid glycine lysine ornithine and taurine using the A300 Amino Acid Analyzer ARACUS membraPure Germany Lactic acid concentrations were also measured using a dedicated plasma lactate determination kit and analyzer LACT2 cobas Roche Diagnostics GmbH Germany Concentrations of amino acids and lactic acid were expressed as micro molg wet weight
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None