Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery Pilot Study
- Conditions
- Heart; Surgery, Heart, Functional Disturbance as Result
- Interventions
- Diagnostic Test: Syndecan-1 concentration evaluation
- Registration Number
- NCT03491163
- Lead Sponsor
- Tadas Cesnaitis
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- Life saving operation.
- Renal or hepatic dysfunction.
- Off-pump heart operation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Syndecan-1 concentration evaluation Syndecan-1 concentration evaluation
- Primary Outcome Measures
Name Time Method Changes of syndecan-1 concentration during surgery and postoperative period. 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.
Glycocalyx damage to patients with diabetes vs non-diabetes during heart surgery. 2 years Compare glycocalyx damage using syndecan-1 concentration changes to diabetic and non-diabetic patents during heart surgery.
Assess the risk of early postoperative complications and find possible correlation to syndecan-1 concentration changes. 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. 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.
The evaluation of aortic clamping and on-pump duration on endothelial glycocalyx damage using syndecan-1 concentration measure. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lithuanian University of Health Sciences
🇱🇹Kaunas, Lithuania