The Role of Endothelial Glycocalyx in Kidney Transplantation

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05651906
Collaborator
(none)
50
1
18
2.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Role of Endothelial Glycocalyx in Kidney Transplantation
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Donors

Recipients

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

Outcome Measures

Primary Outcome Measures

  1. Examination of Endothelial Glycocalyx in Donors [1 year]

    Correlation between the status of EG in donors and kidney function after kidney transplantation (

  2. Examination of Endothelial Glycocalyx in Recipients [1 year]

    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)

Secondary Outcome Measures

  1. Endothelial Glycocalyx under different settings [1 year]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients undergoing kidney transplantation
Exclusion Criteria:
  • Patients who don't sign the informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Hradec Kralove Hradec Králové Czech Republic Czechia 50002

Sponsors and Collaborators

  • Charles University, Czech Republic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pavel Navrátil, MUDr., FEBU, Principal Investigator, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT05651906
Other Study ID Numbers:
  • GCX-KTX
First Posted:
Dec 15, 2022
Last Update Posted:
Dec 15, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pavel Navrátil, MUDr., FEBU, Principal Investigator, Charles University, Czech Republic

Study Results

No Results Posted as of Dec 15, 2022