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It is being revealed that the more severe the damage of the endothelial glycocalyx (EG) layer, the more likely it is that the prognosis of the patients is poor. For that reason, research is being actively conducted on methods for reducing damage and promoting recovery of the EG layer.The natural regeneration process of the EG layer is up to 7 days. Considering the fact that it is quiet slow, reducing the damage of EG layer is considered to be very important for improving the prognosis of patients undergoing surgery, but there is no clinically proven method.
One of the ways receiving attention to reduce damage of EG layer is to stabilize the layer through fluid therapy with albumin. The purpose of this study is to compare the protective effect of the EG layer according to the type of fluid (balanced crystalloid solution vs. 5% albumin) during surgery in patients undergoing off-pump coronary artery bypass surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma A group | Active Comparator | The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery |
|
| Albumin group | Experimental | The group receiving receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma solution-A injection | Drug | The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of Syndecan-1 | The investigators compare the protective effect of EG layer according to the type of fluid used during surgery in patients undergoing off-pump coronary artery bypass surgery. (Comparison of the plasma concentration of Syndecan-1 between the two groups.) | Before induction of anesthesia (1-hour before the start of surgery) |
| Plasma concentration of Syndecan-1 | The investigators compare the protective effect of EG layer according to the type of fluid used during surgery in patients undergoing off-pump coronary artery bypass surgery. (Comparison of the plasma concentration of Syndecan-1 between the two groups.) | At the time of returning the heart in place after coronary artery anastomoses (1~2 hour before the end of surgery) |
| Plasma concentration of Syndecan-1 | The investigators compare the protective effect of EG layer according to the type of fluid used during surgery in patients undergoing off-pump coronary artery bypass surgery. (Comparison of the plasma concentration of Syndecan-1 between the two groups.) | At the time of sternum being closed (30min~1hr before the end of surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of Haparan sulfate | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-α, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-α, IL-6 as well as Syndecan-1, and also identify the overall short-term prognosis of the patients. | Before induction of anesthesia (1hr before the start of surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37989943 | Derived | Nan Z, Soh S, Shim JK, Kim HB, Yang YS, Kwak YL, Song JW. Effect of 5% albumin on endothelial glycocalyx degradation during off-pump coronary artery bypass. Can J Anaesth. 2024 Feb;71(2):244-253. doi: 10.1007/s12630-023-02652-7. Epub 2023 Nov 21. |
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Groups are divided into 2 groups; those receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea), and those receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery
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One researcher (Anesthesiologist) conducts randomized group assignment, and the researcher is not involved in other aspects of anesthesia and research.
Therefore, other researchers, and all those involved in anesthesia, surgery, and postoperative management do not know the patient's group assignment.
| 5% Albumin | Drug | The group receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery |
|
| Plasma concentration of Haparan sulfate | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-α, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-α, IL-6 as well as Syndecan-1, and also identify the overall short-term prognosis of the patients. | At the time of returning the heart in place after coronary artery anastomoses (1~2hr before the end of surgery) |
| Plasma concentration of Haparan sulfate | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-α, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-α, IL-6 as well as Syndecan-1, and also identify the overall short-term prognosis of the patients. | At the time of sternum being closed (30min~1hr before the end of surgery) |
| Plasma concentration of ANP | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-α, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-α, IL-6 as well as Syndecan-1, and also identify the overall short-term prognosis of the patients. | Before induction of anesthesia (1hr before the start of surgery) |
| Plasma concentration of ANP | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-α, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-α, IL-6 as well as Syndecan-1, and also identify the overall short-term prognosis of the patients. | At the time of returning the heart in place after coronary artery anastomoses (1~2hr before the end of surgery) |
| Plasma concentration of TNF-α/IL-6 | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-α, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-α, IL-6 as well as Syndecan-1, and also identify the overall short-term prognosis of the patients. | Before induction of anesthesia (1hr before the start of surgery) |
| Plasma concentration of TNF-α/IL-6 | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-α, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-α, IL-6 as well as Syndecan-1, and also identify the overall short-term prognosis of the patients. | At the time of sternum being closed (30min~1hr before the end of surgery) |
| Composite rate of morbidity and mortality | Composite morbidity and mortality (Mortality, Stroke, Re-operation, Sternal infection, Prolonged ventilation, Renal dysfunction) | If the hospitalization period is within 30 days, follow-up is done up to 30 days. |
| Composite rate of morbidity and mortality | Composite morbidity and mortality (Mortality, Stroke, Re-operation, Sternal infection, Prolonged ventilation, Renal dysfunction) | If the hospitalization period exceeds 30 days, follow-up is done throughout the hospitalization period. |
| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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