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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Occlusive Disease(CAOD)

Treatments: Drug: 5% Albumin; Drug: Plasma solution-A injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03699462

4-2018-0670

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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106 participants in 2 patient groups

Plasma A group

Active Comparator group

Description:

The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery

Treatment:

Drug: Plasma solution-A injection

Albumin group

Experimental group

Description:

The group receiving receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery

Treatment:

Drug: 5% Albumin