The Role of Endothelial Glycocalyx in Kidney Transplantation

The goal of this observational study is detailed examination of endothelial glycocalyx in kidney transplantation. Researchers will evaluate markers of degradation of EG in blood and urine; and also perform direct visualisation of EG with sidestream dark field imaging (SDF) in both donors and recipients of kidney transplantation.

The aim is to summarize the current knowledge and to point out the importance of EG in kidney transplantation.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplantation
• Intervention / Treatment: Procedure: Kidney Transplantation

Detailed Description

The endothelial glycocalyx (EG) is a thin layer on the surface of the endothelium that plays an important role for microcirculation and tissue metabolism. The role of EG is diverse - it acts as a protection of the endothelium against shear stress which is mediated on the intracellular structures of endothelial cells, allows the interaction of blood elements and endothelium, prevents the formation of uncontrolled thrombosis and excessive oxidative stress by free radicals. EG dysfunction can occur with partial or complete loss of its components, resulting in impaired vascular regulation and increased vascular permeability. Disruption or dysfunction of EG has been associated with disease states such as diabetes, chronic kidney disease, inflammatory conditions, sepsis, hypernatraemia, hypervolaemia and ischaemia/reperfusion injury. Enzymes such as hyaluronidase and metalloproteinases can degrade the components of EG. Damage to EG leads to the release of breakdown products into the bloodstream which can be detected. There are also direct methods of visualization of EG. Thanks to advances in the study of EG in kidney transplantation a comprehensive relationship in this field and specific clinical aspects can be assessed. In the future exploring potential therapeutic options to protect EG may have implications for better graft function and survival.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Czechia
  • Czech Republic
    • Hradec Králové, Czech Republic, Czechia, 50002
      • Recruiting
      • University Hospital Hradec Kralove
      • Contact: Pavel Navratil; Phone Number: 00420495833378; Email: pavel.navratil2@fnhk.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Group 1: Donors after brain death, Donors after circulatory death Group 2: Patients with end-stage renal disease who are eligible for kidney transplantation

Description

Inclusion Criteria:

• Patients undergoing kidney transplantation

Exclusion Criteria:

• Patients who don't sign the informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Donors
Recipients	Procedure: Kidney Transplantation; Kidney transplantation as the best option for patients with end-stage kidney disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examination of Endothelial Glycocalyx in Donors	Correlation between the status of EG in donors and kidney function after kidney transplantation (	1 year
Examination of Endothelial Glycocalyx in Recipients	Description of microcirculation directly from the kidney's surface in 1 and 20 minutes after reperfusion (with Side stream darkfield imaging and Perfused boundary region)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Glycocalyx under different settings	Description of EG in living donors, donors after brain death, donors after circulatory death (measurements of degradation products od EG - mainly syndecan-1 in blood and urine)	1 year

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Glycocalyx; Endothelial
• Other Study ID Numbers: GCX-KTX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No