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

NCT ID: NCT03491163

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-29

Study Completion Date

2020-07-01

Brief Summary

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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

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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.

Conditions

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Heart; Surgery, Heart, Functional Disturbance as Result

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Syndecan-1 concentration evaluation

Syndecan-1 concentration evaluation

Intervention Type DIAGNOSTIC_TEST

Blood sample will be taken and analysed using ELISA method.

Interventions

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Syndecan-1 concentration evaluation

Blood sample will be taken and analysed using ELISA method.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tadas Cesnaitis

OTHER

Sponsor Role lead

Responsible Party

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Tadas Cesnaitis

PhD student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Edmundas Sirvinskas, Prof

Role: PRINCIPAL_INVESTIGATOR

Professor at Lithuanian University of Health Sciences

Locations

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Lithuanian University of Health Sciences

Kaunas, , Lithuania

Site Status RECRUITING

Countries

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Lithuania

Central Contacts

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Tadas Cesnaitis

Role: CONTACT

+37037326171

Facility Contacts

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Tadas Cesnaitis, MD

Role: primary

+37037326171

Edmundas Sirvinskas, Prof

Role: backup

+37037326171

Other Identifiers

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ENDOTEL SYNDECAN-1

Identifier Type: -

Identifier Source: org_study_id

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