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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
Sponsor:
Information provided by (Responsible Party):
Tadas Cesnaitis, Lithuanian University of Health Sciences

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.

Condition or disease Intervention/treatment
Heart; Surgery, Heart, Functional Disturbance as Result Diagnostic Test: Syndecan-1 concentration evaluation

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Patients
Syndecan-1 concentration evaluation
Diagnostic Test: Syndecan-1 concentration evaluation
Blood sample will be taken and analysed using ELISA method.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Tadas Cesnaitis +37037326171 tadas.cesnaitis@lsmuni.lt

Locations
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Lithuania
Lithuanian University of Health Sciences Recruiting
Kaunas, Lithuania, LT44307
Contact: Tadas Cesnaitis, MD    +37037326171    tadas.cesnaitis@lsmuni.lt   
Contact: Edmundas Sirvinskas, Prof    +37037326171    edmundas.sirvinskas@lsmuni.lt   
Sponsors and Collaborators
Tadas Cesnaitis
Investigators
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Principal Investigator: Edmundas Sirvinskas, Prof Professor at Lithuanian University of Health Sciences

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Responsible Party: Tadas Cesnaitis, PhD student, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT03491163    
Other Study ID Numbers: ENDOTEL SYNDECAN-1
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tadas Cesnaitis, Lithuanian University of Health Sciences:
syndecan-1
endothelial glycocalyx
On-pump heart surgery