Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery.

NCT03491163 | Completed

• 1 other identifier: ENDOTEL SYNDECAN-1
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  2 years

Study Arms (1)

Patients

Syndecan-1 concentration evaluation

Diagnostic Test: Syndecan-1 concentration evaluation

Interventions

Syndecan-1 concentration evaluation DIAGNOSTIC_TEST

Blood sample will be taken and analysed using ELISA method.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Kaunas County, LT44307, Lithuania

Location

Study Officials

• Tadas Lenkutis, Doc.

  Heart centre, Lithuanian University of Health Sciences

  STUDY CHAIR

• Tadas Cesnaitis, MD

  Heart centre, Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 9, 2018
• Study Start: March 29, 2018
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2020
• Last Updated: June 4, 2026

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)