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Completed

NCT Number: NCT03491163

Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery.

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.

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Key information

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lithuanian University of Health Sciences

Kaunas, Kaunas County, LT44307, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Syndecan-1 concentration evaluation

Diagnostic Test

Blood sample will be taken and analysed using ELISA method.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 9, 2018
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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