The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery

Conditions
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Coronary Artery Occlusive Disease(CAOD)

Intervention / Treatment
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* Drug: Plasma solution-A injection
* Drug: 5% Albumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 20 years of age undergoing off-pump coronary artery bypass surgery Exclusion Criteria: Emergency operation Minimally-invasive surgery (under one-lung ventilation) Chronic kidney disease (eGFR<30 ml/min/1.73m2) or Dialysis Acute kidney injury Infectious disease Preoperative steroid use Malignancy Reported allergic reaction to albumin preparations Patients who participated in other clinical studies that could affect prognosis Patients who have difficulty in reading the informed consent and voluntarily agreeing to participate in the study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plasma A group<br>The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery | Drug: Plasma solution-A injection<br>* The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery<br>|
| Experimental: Albumin group<br>The group receiving receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery | Drug: 5% Albumin<br>* The group receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial Glycocalyx (EG), 5% albumin, off-pump coronary artery bypass surgery (OPCAB)