Heart; Surgery, Heart, Functional Disturbance as ResultNCT03491163
Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery.
An observational study of Heart; Surgery, Heart, Functional Disturbance as Result, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
Evaluation of endothelial glycocalyx damage in on-pump conventional coronary artery bypass surgery using a syndecan-1 (CD138) blood test. The study will be carried out in two stages. Pilot study for testing and correcting research methodology and the main study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Surgery, Heart, Functional Disturbance as Result
- What is being tested?
- Syndecan-1 concentration evaluation
- How many people
- 147 participants
- Where
- 1 siteLithuania
- Study dates
- 29 Mar 2018to 30 Oct 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with normal or compensated heart function, with normal inflammatory status, who have agreed to participate in the study. Patients undergoing elective on-pump coronary artery bypass surgery.
Who may be able to join
- Elective on-pump coronary artery bypass surgery needed.
- Normal heart function at the time of operation.
- Patients without infections.
- Patients who signed study informed consent form
Who cannot join
- Life saving operation.
- Renal or hepatic dysfunction.
- Off-pump heart operation.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Lithuanian University of Health Sciences
Kaunas, Kaunas County, LT44307
About this study
Official title: Evaluation of Damaging Factors to Endothelial Glycocalyx During On-pump Coronary Artery Bypass Surgery Using Syndecan-1 Biomarker.
Evaluation of endothelial glycocalyx damage in on-pump conventional coronary artery bypass surgery using a syndecan-1 (CD138) blood test. The study will be carried out in two stages. Pilot study for testing and correcting research methodology and the main study.
Read the detailed description
Study tasks:
- To evaluate changes of syndecan-1 concentration during surgery and postoperative period.
- Determine the effect of aortic clamping and on-pump duration on endothelial glycocalyx damage.
- Assess the risk of early postoperative complications and syndecan-1 plasma concentrations.
- To evaluate the correlation of inflammatory status with glycocalyx damage.
- To evaluate glycocalyx damage to patients with diabetes vs non-diabetes.
Methods:
Patients undergoing cardiopulmonary bypass surgery are being treated at the Heart, Chest and Vascular Surgery Clinic of the Lithuanian University of Health Sciences Hospital in Kaunas Clinics. After receiving patients written consent a syndecan-1 concentration test will be performed upon arrival at the operating room, before cardiopulmonary bypass (CPB), after CPB, upon arrival in the ICU and after 24 hours.
All needed data for evaluating patients outcome will be taken from medical documentation during patients stay in hospital.
- Being tested
- Syndecan-1 concentration evaluation
- Keywords
- syndecan-1, endothelial glycocalyx, On-pump heart surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syndecan-1 concentration evaluationDiagnostic test
Blood sample will be taken and analysed using ELISA method.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Syndecan-1 concentration evaluation Receives: Diagnostic Test: Syndecan-1 concentration evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of syndecan-1 concentration during surgery and postoperative period.
Concentration of syndecan-1 will be measured by taking patients blood sample before operation, after aortic cannulation, after CPB, when arriving to ICU and 24 hours after operation. Means of concentration changes will be compared to determine which period of operation has the biggest impact to endothelial glycocalyx shedding.
Measured: 2 years
The evaluation of aortic clamping and on-pump duration on endothelial glycocalyx damage using syndecan-1 concentration measure.
Concentrations of syndecan-1 will be evaluated considering the duration of aortic clamping and CPB. Optimal duration will be searched for minimal impact to endothelial glycocalyx.
Measured: 2 years
Assess the risk of early postoperative complications and find possible correlation to syndecan-1 concentration changes.
All negative events after operation will be recorded and statistically correlated with syndecan-1 concentration changes.
Measured: 2 years
The correlation of inflammatory status with glycocalyx damage.
Leucocytosis and C reactive protein levels will be evaluated before, after heart operation and 24 hours later. Data will be compared to syndecan-1 concentration changes.
Measured: 2 years
Glycocalyx damage to patients with diabetes vs non-diabetes during heart surgery.
Compare glycocalyx damage using syndecan-1 concentration changes to diabetic and non-diabetic patents during heart surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start29 Mar 2018
- Primary completion30 Oct 2019
- Study completion30 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 Heart; Surgery, Heart, Functional Disturbance as ResultStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadas Cesnaitis, Lithuanian University of Health Sciences
- Investigators
- Tadas Lenkutis, Doc., Study chair, Heart centre, Lithuanian University of Health SciencesTadas Cesnaitis, MD, Principal investigator, Heart centre, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491163
- Sponsor's protocol ID
- ENDOTEL SYNDECAN-1
- Status last verified
- Sep 2019
- First submitted
- 29 Mar 2018
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cesnaitis T, Lenkutis T, Paukstaitiene R, Bukauskiene R, Andrejaitiene J, Vitkauskiene A, Benetis R. Perioperative Syndecan-1 Dynamics During Cardiac Surgery: Associations with Operative Factors and Patient Characteristics. Medicina (Kaunas). 2026 Jul 6;62(7):1305. doi: 10.3390/medicina62071305.
PubMed 42512848
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Damaging Factors to Endothelial Glycocalyx During On-pump Coronary Artery Bypass Surgery Using Syndecan-1 Biomarker.
- ClinicalTrials.gov ID
- NCT03491163
- Acronym / sponsor ID
- ENDOTEL SYNDECAN-1
- Keywords
- syndecan-1, endothelial glycocalyx, On-pump heart surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 9 Apr 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.
Evaluation of endothelial glycocalyx damage in on-pump conventional coronary artery bypass surgery using a syndecan-1 (CD138) blood test. The study will be carried out in two stages. Pilot study for testing and correcting research methodology and the main study.
Detailed description
Study tasks:
- To evaluate changes of syndecan-1 concentration during surgery and postoperative period.
- Determine the effect of aortic clamping and on-pump duration on endothelial glycocalyx damage.
- Assess the risk of early postoperative complications and syndecan-1 plasma concentrations.
- To evaluate the correlation of inflammatory status with glycocalyx damage.
- To evaluate glycocalyx damage to patients with diabetes vs non-diabetes.
Methods:
Patients undergoing cardiopulmonary bypass surgery are being treated at the Heart, Chest and Vascular Surgery Clinic of the Lithuanian University of Health Sciences Hospital in Kaunas Clinics. After receiving patients written consent a syndecan-1 concentration test will be performed upon arrival at the operating room, before cardiopulmonary bypass (CPB), after CPB, upon arrival in the ICU and after 24 hours.
All needed data for evaluating patients outcome will be taken from medical documentation during patients stay in hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Syndecan-1 concentration evaluationSyndecan-1 concentration evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with normal or compensated heart function, with normal inflammatory status, who have agreed to participate in the study. Patients undergoing elective on-pump coronary artery bypass surgery.
Key inclusion criteria (4 listed)
- Elective on-pump coronary artery bypass surgery needed.
- Normal heart function at the time of operation.
- Patients without infections.
- Patients who signed study informed consent form
Key exclusion criteria (3 listed)
- Life saving operation.
- Renal or hepatic dysfunction.
- Off-pump heart operation.
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 |
|---|---|---|
| Syndecan-1 concentration evaluationBlood sample will be taken and analysed using ELISA method. | Diagnostic test | Patients |
Primary outcome
Changes of syndecan-1 concentration during surgery and postoperative period.
Time frame: 2 years
Concentration of syndecan-1 will be measured by taking patients blood sample before operation, after aortic cannulation, after CPB, when arriving to ICU and 24 hours after operation. Means of concentration changes will be compared to determine which period of operation has the biggest impact to endothelial glycocalyx shedding.
The evaluation of aortic clamping and on-pump duration on endothelial glycocalyx damage using syndecan-1 concentration measure.
Time frame: 2 years
Concentrations of syndecan-1 will be evaluated considering the duration of aortic clamping and CPB. Optimal duration will be searched for minimal impact to endothelial glycocalyx.
Assess the risk of early postoperative complications and find possible correlation to syndecan-1 concentration changes.
Time frame: 2 years
All negative events after operation will be recorded and statistically correlated with syndecan-1 concentration changes.
The correlation of inflammatory status with glycocalyx damage.
Time frame: 2 years
Leucocytosis and C reactive protein levels will be evaluated before, after heart operation and 24 hours later. Data will be compared to syndecan-1 concentration changes.
Glycocalyx damage to patients with diabetes vs non-diabetes during heart surgery.
Time frame: 2 years
Compare glycocalyx damage using syndecan-1 concentration changes to diabetic and non-diabetic patents during heart surgery.
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 4 Jun 2026.
- Derived from this study: PubMed 42512848Cesnaitis T, Lenkutis T, Paukstaitiene R, Bukauskiene R, Andrejaitiene J, Vitkauskiene A, Benetis R. Perioperative Syndecan-1 Dynamics During Cardiac Surgery: Associations with Operative Factors and Patient Characteristics. Medicina (Kaunas). 2026 Jul 6;62(7):1305. doi: 10.3390/medicina62071305.
- 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.
Tadas Lenkutis, Doc. study chair
Heart centre, Lithuanian University of Health Sciences
Tadas Cesnaitis, MD principal investigator
Heart centre, Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart; Surgery, Heart, Functional Disturbance as Result, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 4 inclusion and 3 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 4 Jun 2026. 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 Lithuania. 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.
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?
Changes of syndecan-1 concentration during surgery and postoperative period. (time frame: 2 years). The study lists 5 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 NCT03491163, 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 4 Jun 2026.