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Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery Pilot Study

T

Tadas Cesnaitis

Status

Unknown

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Treatments

Diagnostic Test: Syndecan-1 concentration evaluation

Study type

Observational

Funder types

Other

Identifiers

NCT03491163
ENDOTEL SYNDECAN-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Patients
Description:
Syndecan-1 concentration evaluation
Treatment:
Diagnostic Test: Syndecan-1 concentration evaluation

Trial contacts and locations

1

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Central trial contact

Tadas Cesnaitis

Data sourced from clinicaltrials.gov

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