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

NCT ID: NCT03699462

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2020-10-17

Brief Summary

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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

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Conditions

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Coronary Artery Occlusive Disease(CAOD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Plasma A group

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

Group Type ACTIVE_COMPARATOR

Plasma solution-A injection

Intervention Type DRUG

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

Albumin group

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

Group Type EXPERIMENTAL

5% Albumin

Intervention Type DRUG

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

Interventions

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Plasma solution-A injection

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

Intervention Type DRUG

5% Albumin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 37989943 (View on PubMed)

Other Identifiers

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4-2018-0670

Identifier Type: -

Identifier Source: org_study_id