- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03699462
The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 03722
- Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Plasma A group
The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery
|
The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery
|
EXPERIMENTAL: Albumin group
The group receiving receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery
|
The group receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma concentration of Syndecan-1
Time Frame: 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.)
|
Before induction of anesthesia (1-hour before the start of surgery)
|
Plasma concentration of Syndecan-1
Time Frame: At the time of returning the heart in place after coronary artery anastomoses (1~2 hour before the end 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.)
|
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
Time Frame: At the time of sternum being closed (30min~1hr before the end 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.)
|
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
Time Frame: 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.
|
Before induction of anesthesia (1hr before the start of surgery)
|
Plasma concentration of Haparan sulfate
Time Frame: At the time of returning the heart in place after coronary artery anastomoses (1~2hr before the end 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.
|
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
Time Frame: At the time of sternum being closed (30min~1hr before the end 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.
|
At the time of sternum being closed (30min~1hr before the end of surgery)
|
Plasma concentration of ANP
Time Frame: 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.
|
Before induction of anesthesia (1hr before the start of surgery)
|
Plasma concentration of ANP
Time Frame: At the time of returning the heart in place after coronary artery anastomoses (1~2hr before the end 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.
|
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
Time Frame: 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.
|
Before induction of anesthesia (1hr before the start of surgery)
|
Plasma concentration of TNF-α/IL-6
Time Frame: At the time of sternum being closed (30min~1hr before the end 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.
|
At the time of sternum being closed (30min~1hr before the end of surgery)
|
Composite rate of morbidity and mortality
Time Frame: 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)
|
If the hospitalization period is within 30 days, follow-up is done up to 30 days.
|
Composite rate of morbidity and mortality
Time Frame: If the hospitalization period exceeds 30 days, follow-up is done throughout the hospitalization period.
|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 4-2018-0670
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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