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

Heart; Surgery, Heart, Functional Disturbance as Result Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03491163
• Other study ID #: ENDOTEL SYNDECAN-1
• Status: Recruiting
• Start date: March 29, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2018
• Source: Lithuanian University of Health Sciences
• Contact: Tadas Cesnaitis
• Phone: +37037326171
• Email: tadas.cesnaitis[@]lsmuni.lt
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart; Surgery, Heart, Functional Disturbance as Result
• Pathologic Processes

Intervention

Diagnostic Test:
• Syndecan-1 concentration evaluation
Blood sample will be taken and analysed using ELISA method.

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Tadas Cesnaitis

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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