Skip to content

Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery.

Evaluation of Damaging Factors to Endothelial Glycocalyx During On-pump Coronary Artery Bypass Surgery Using Syndecan-1 Biomarker.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03491163
Enrollment
147
Registered
2018-04-09
Start date
2018-03-29
Completion date
2020-10-30
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Keywords

syndecan-1, endothelial glycocalyx, On-pump heart surgery

Brief 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.

Detailed description

Study tasks: 1. To evaluate changes of syndecan-1 concentration during surgery and postoperative period. 2. Determine the effect of aortic clamping and on-pump duration on endothelial glycocalyx damage. 3. Assess the risk of early postoperative complications and syndecan-1 plasma concentrations. 4. To evaluate the correlation of inflammatory status with glycocalyx damage. 5. 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.

Interventions

DIAGNOSTIC_TESTSyndecan-1 concentration evaluation

Blood sample will be taken and analysed using ELISA method.

Sponsors

Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Life saving operation. * Renal or hepatic dysfunction. * Off-pump heart operation.

Design outcomes

Primary

MeasureTime frameDescription
Changes of syndecan-1 concentration during surgery and postoperative period.2 yearsConcentration 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.2 yearsConcentrations 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.2 yearsAll negative events after operation will be recorded and statistically correlated with syndecan-1 concentration changes.
The correlation of inflammatory status with glycocalyx damage.2 yearsLeucocytosis 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.2 yearsCompare glycocalyx damage using syndecan-1 concentration changes to diabetic and non-diabetic patents during heart surgery.

Countries

Lithuania

Contacts

STUDY_CHAIRTadas Lenkutis, Doc.

Heart centre, Lithuanian University of Health Sciences

PRINCIPAL_INVESTIGATORTadas Cesnaitis, MD

Heart centre, Lithuanian University of Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026