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

Phase 4

Completed

• Conditions: Coronary Artery Occlusive Disease(CAOD)
• Interventions: Drug: Plasma solution-A injection; Drug: 5% Albumin

• Registration Number: NCT03699462
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Study Start: 2018-11-13
• Status Verified: 2020-10
• Primary Completion: 2020-10-17
• Study Completion: 2020-10-17
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Patients over 20 years of age undergoing off-pump coronary artery bypass surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasma A group	Plasma solution-A injection	The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery
Albumin group	5% Albumin	The group receiving receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Syndecan-1	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.)

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of Haparan sulfate	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.
Plasma concentration of ANP	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.
Plasma concentration of TNF-α/IL-6	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.
Composite rate of morbidity and mortality	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)

Trial Locations

Locations (1)

Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of