Coronary Artery Occlusive Disease(CAOD)
Conditions
Keywords
Endothelial Glycocalyx (EG), 5% albumin, off-pump coronary artery bypass surgery (OPCAB)
Brief summary
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.
Interventions
DRUGPlasma solution-A injection
The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery
DRUG5% Albumin
The group receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of Syndecan-1 | Before induction of anesthesia (1-hour before the start of surgery) | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of Haparan sulfate | Before induction of anesthesia (1hr before the start of surgery) | 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. |
| Plasma concentration of ANP | Before induction of anesthesia (1hr before the start of surgery) | 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. |
| Plasma concentration of TNF-α/IL-6 | Before induction of anesthesia (1hr before the start of surgery) | 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. |
| Composite rate of morbidity and mortality | If the hospitalization period is within 30 days, follow-up is done up to 30 days. | Composite morbidity and mortality (Mortality, Stroke, Re-operation, Sternal infection, Prolonged ventilation, Renal dysfunction) |
Countries
South Korea
Outcome results
None listed