Clinical trial NCT03699462: The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
Official title: The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Occlusive Disease(CAOD)
Keywords: Endothelial Glycocalyx (EG)
5% albumin
off-pump coronary artery bypass surgery (OPCAB)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentration of Syndecan-1
timeFrame: Before induction of anesthesia (1-hour before the start of surgery)
measure: Plasma concentration of Syndecan-1
timeFrame: At the time of returning the heart in place after coronary artery anastomoses (1~2 hour before the end of surgery)
measure: Plasma concentration of Syndecan-1
timeFrame: At the time of sternum being closed (30min~1hr before the end of surgery)
Secondary outcomes:
measure: Plasma concentration of Haparan sulfate
timeFrame: Before induction of anesthesia (1hr before the start of surgery)
measure: Plasma concentration of Haparan sulfate
timeFrame: At the time of returning the heart in place after coronary artery anastomoses (1~2hr before the end of surgery)
measure: Plasma concentration of Haparan sulfate
timeFrame: At the time of sternum being closed (30min~1hr before the end of surgery)
measure: Plasma concentration of ANP
timeFrame: Before induction of anesthesia (1hr before the start of surgery)
measure: Plasma concentration of ANP
timeFrame: At the time of returning the heart in place after coronary artery anastomoses (1~2hr before the end of surgery)
measure: Plasma concentration of TNF-α/IL-6
timeFrame: Before induction of anesthesia (1hr before the start of surgery)
measure: Plasma concentration of TNF-α/IL-6
timeFrame: At the time of sternum being closed (30min~1hr before the end of surgery)
measure: Composite rate of morbidity and mortality
timeFrame: If the hospitalization period is within 30 days, follow-up is done up to 30 days.
measure: Composite rate of morbidity and mortality
timeFrame: If the hospitalization period exceeds 30 days, follow-up is done throughout the hospitalization period.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine
Study officials:
References: