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

October 29, 2020 updated by: Yonsei University

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

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2018

Primary Completion (ACTUAL)

October 17, 2020

Study Completion (ACTUAL)

October 17, 2020

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (ACTUAL)

October 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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