Clinical trial NCT03491163: Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery Pilot Study
Official title: Evaluation of Damaging Factors to Endothelial Glycocalyx During On-pump Coronary Artery Bypass Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
Keywords: syndecan-1
endothelial glycocalyx
On-pump heart surgery
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of syndecan-1 concentration during surgery and postoperative period.
timeFrame: 2 years
measure: The evaluation of aortic clamping and on-pump duration on endothelial glycocalyx damage using syndecan-1 concentration measure.
timeFrame: 2 years
measure: Assess the risk of early postoperative complications and find possible correlation to syndecan-1 concentration changes.
timeFrame: 2 years
measure: The correlation of inflammatory status with glycocalyx damage.
timeFrame: 2 years
measure: Glycocalyx damage to patients with diabetes vs non-diabetes during heart surgery.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Professor at Lithuanian University of Health Sciences
name: Edmundas Sirvinskas, Prof
role: PRINCIPAL_INVESTIGATOR
References: