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

Evaluation of Damaging Factors to Endothelial Glycocalyx During On-pump Coronary Artery Bypass 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.

Study Overview

• Status: Unknown
• Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
• Intervention / Treatment: Diagnostic test: Syndecan-1 concentration evaluation

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Tadas Cesnaitis; Phone Number: +37037326171; Email: tadas.cesnaitis@lsmuni.lt

Study Locations

• Lithuania
  • Kaunas, Lithuania, LT44307
    • Recruiting
    • Lithuanian University of Health Sciences
    • Contact: Tadas Cesnaitis, MD; Phone Number: +37037326171; Email: tadas.cesnaitis@lsmuni.lt
    • Contact: Edmundas Sirvinskas, Prof; Phone Number: +37037326171; Email: edmundas.sirvinskas@lsmuni.lt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Syndecan-1 concentration evaluation	Diagnostic test: Syndecan-1 concentration evaluation; Blood sample will be taken and analysed using ELISA method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tadas Cesnaitis
• Investigators: Principal Investigator: Edmundas Sirvinskas, Prof, Professor at Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: endothelial glycocalyx; syndecan-1; On-pump heart surgery
• Other Study ID Numbers: ENDOTEL SYNDECAN-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No