Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery Pilot Study
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|ClinicalTrials.gov Identifier: NCT03491163|
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment|
|Heart; Surgery, Heart, Functional Disturbance as Result||Diagnostic Test: Syndecan-1 concentration evaluation|
- 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.
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|
|Estimated Enrollment :||150 participants|
|Official Title:||Evaluation of Damaging Factors to Endothelial Glycocalyx During On-pump Coronary Artery Bypass Surgery|
|Actual Study Start Date :||March 29, 2018|
|Estimated Primary Completion Date :||October 30, 2019|
|Estimated Study Completion Date :||July 1, 2020|
Syndecan-1 concentration evaluation
Diagnostic Test: Syndecan-1 concentration evaluation
Blood sample will be taken and analysed using ELISA method.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491163
|Contact: Tadas Cesnaitisemail@example.com|
|Principal Investigator:||Edmundas Sirvinskas, Prof||Professor at Lithuanian University of Health Sciences|