Coronary Artery Occlusive Disease(CAOD) Clinical Trial
Official title:
The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
| Verified date | October 2020 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 106 |
| Est. completion date | October 17, 2020 |
| Est. primary completion date | October 17, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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 | Plasma concentration of Haparan sulfate | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-a, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-a, 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) | |
| Secondary | Plasma concentration of Haparan sulfate | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-a, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-a, 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) | |
| Secondary | Plasma concentration of Haparan sulfate | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-a, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-a, 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) | |
| Secondary | Plasma concentration of ANP | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-a, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-a, 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) | |
| Secondary | Plasma concentration of ANP | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-a, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-a, 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) | |
| Secondary | Plasma concentration of TNF-a/IL-6 | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-a, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-a, 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) | |
| Secondary | Plasma concentration of TNF-a/IL-6 | Heparan sulfate is one of the indicators of EG damage, and ANP & TNF-a, IL-6 are known to correlate with EG damage. So in this study, the investigators measure the plasma concentrations of Haparan sulfate, ANP & TNF-a, 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) | |
| Secondary | 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. | |
| Secondary | 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. |