The Role of Endothelial Glycocalyx in Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

The Role of Endothelial Glycocalyx in Kidney Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651906
• Other study ID #: GCX-KTX
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing kidney transplantation

Exclusion Criteria:

• Patients who don't sign the informed consent

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Procedure:
• Kidney Transplantation
Kidney transplantation as the best option for patients with end-stage kidney disease.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Králové	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of Endothelial Glycocalyx in Donors	Correlation between the status of EG in donors and kidney function after kidney transplantation (	1 year
Primary	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	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