Coronary Artery Occlusive Disease(CAOD)Phase 4NCT03699462
The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
A Phase 4 study testing Plasma solution-A injection and 5% Albumin in people with Coronary Artery Occlusive Disease(CAOD), run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Occlusive Disease(CAOD)
- What is being tested?
- Plasma solution-A injection and 5% Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2018to 17 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 20 years of age undergoing off-pump coronary artery bypass surgery
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiac Anesthesiology, Department of Anesthesiology and Pain Medicine, Cardiovascular Hospital, Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
About this study
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)
- Being tested
- Plasma solution-A injection, 5% Albumin
- Keywords
- Endothelial Glycocalyx (EG), 5% albumin, off-pump coronary artery bypass surgery (OPCAB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma solution-A injectionDrug
The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery
5% AlbuminDrug
The group receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery
| Study group | Role | What they receive |
|---|---|---|
| Plasma A group | Active comparator | The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery Receives: Drug: Plasma solution-A injection |
| Albumin group | Experimental | The group receiving receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery Receives: Drug: 5% Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.)
Measured: 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.)
Measured: At the time of sternum being closed (30min~1hr before the end of surgery)
Secondary outcomes (9)
Plasma concentration of Haparan sulfate
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.
Measured: Before induction of anesthesia (1hr before the start of surgery)
Plasma concentration of Haparan sulfate
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.
Measured: 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
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.
Measured: At the time of sternum being closed (30min~1hr before the end of surgery)
Plasma concentration of ANP
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.
Measured: Before induction of anesthesia (1hr before the start of surgery)
Plasma concentration of ANP
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.
Measured: 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
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.
Measured: Before induction of anesthesia (1hr before the start of surgery)
Plasma concentration of TNF-α/IL-6
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.
Measured: At the time of sternum being closed (30min~1hr before the end of surgery)
Composite rate of morbidity and mortality
Composite morbidity and mortality (Mortality, Stroke, Re-operation, Sternal infection, Prolonged ventilation, Renal dysfunction)
Measured: If the hospitalization period is within 30 days, follow-up is done up to 30 days.
Composite rate of morbidity and mortality
Composite morbidity and mortality (Mortality, Stroke, Re-operation, Sternal infection, Prolonged ventilation, Renal dysfunction)
Measured: If the hospitalization period exceeds 30 days, follow-up is done throughout the hospitalization period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start13 Nov 2018
- Primary completion17 Oct 2020
- Study completion17 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Occlusive Disease(CAOD)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699462
- Sponsor's protocol ID
- 4-2018-0670
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2018
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37989943
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT03699462
- Acronym / sponsor ID
- 4-2018-0670
- Conditions
- Coronary Artery Occlusive Disease(CAOD)
- Keywords
- Endothelial Glycocalyx (EG), 5% albumin, off-pump coronary artery bypass surgery (OPCAB)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 17 Oct 2020 (actual)
- Study completion
- 17 Oct 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Plasma A group | Active comparator | Drug: Plasma solution-A injectionThe group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery |
| Albumin group | Experimental | Drug: 5% AlbuminThe group receiving receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 20 years of age undergoing off-pump coronary artery bypass surgery
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma solution-A injectionThe group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery | Drug | Plasma A group |
| 5% AlbuminThe group receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery | Drug | Albumin group |
Primary outcome
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.)
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.)
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.)
9 secondary outcomes
Plasma concentration of Haparan sulfate
Time frame: 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)
Plasma concentration of Haparan sulfate
Time frame: 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)
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)
Plasma concentration of TNF-α/IL-6
Time frame: 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)
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 rate of morbidity and mortality
Time frame: If the hospitalization period exceeds 30 days, follow-up is done throughout the hospitalization period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Derived from this study: PubMed 37989943Nan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasma solution-A injection and 5% Albumin in people with Coronary Artery Occlusive Disease(CAOD), run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of Syndecan-1 (time frame: Before induction of anesthesia (1-hour before the start of surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03699462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.