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

NCT03699462 | Completed Phase 4

• 1 other identifier: 4-2018-0670
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Occlusive Disease(CAOD)

Keywords

Endothelial Glycocalyx (EG); 5% albumin; off-pump coronary artery bypass surgery (OPCAB)

Outcome Measures

Primary Outcomes (3)

• Plasma concentration of Syndecan-1

  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

  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

  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 Outcomes (9)

• Plasma concentration of Haparan sulfate

  Before induction of anesthesia (1hr before the start of surgery)

• Plasma concentration of Haparan sulfate

  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

  At the time of sternum being closed (30min~1hr before the end of surgery)

• Plasma concentration of ANP

  Before induction of anesthesia (1hr before the start of surgery)

• Plasma concentration of ANP

  At the time of returning the heart in place after coronary artery anastomoses (1~2hr before the end of surgery)

Study Arms (2)

Plasma A group

ACTIVE COMPARATOR

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

Drug: Plasma solution-A injection

Albumin group

EXPERIMENTAL

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

Drug: 5% Albumin

Interventions

Plasma solution-A injection DRUG

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

Plasma A group

5% Albumin DRUG

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

Albumin group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (1)

• Nan Z, Soh S, Shim JK, Kim HB, Yang YS, Kwak YL, Song JW. Effect of 5% albumin on endothelial glycocalyx degradation during off-pump coronary artery bypass. Can J Anaesth. 2024 Feb;71(2):244-253. doi: 10.1007/s12630-023-02652-7. Epub 2023 Nov 21.

  PMID: 37989943 DERIVED

MeSH Terms

Interventions

Albumins

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: One researcher (Anesthesiologist) conducts randomized group assignment, and the researcher is not involved in other aspects of anesthesia and research. Therefore, other researchers, and all those involved in anesthesia, surgery, and postoperative management do not know the patient's group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 9, 2018
• Study Start: November 13, 2018
• Primary Completion: October 17, 2020
• Study Completion: October 17, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)