NCT05651906

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

November 14, 2022

Last Update Submit

February 26, 2024

Conditions

Kidney Transplantation

Keywords

EndothelialGlycocalyx

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Endothelial Glycocalyx under different settings

    1 year

Study Arms (2)

Donors

Recipients

Procedure: Kidney Transplantation

Interventions

Kidney TransplantationPROCEDURE

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

Recipients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Patients undergoing kidney transplantation

You may not qualify if:

  • Patients who don't sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, Czech Republic, 50002, Czechia

RECRUITING

MeSH Terms

Interventions

Kidney Transplantation

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2022

First Posted

December 15, 2022

Study Start

December 1, 2022

Primary Completion

December 31, 2024

Study Completion

May 31, 2025

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

CZ(1)