Microvascular perfusion in renal ischemia/reperfusion injury during clinical kidney transplantation: an observational study.

Withdrawn

• Conditions: ischemia/reperfusion injury; Kidney transplantation; 10029149; 10003184

• Registration Number: NL-OMON36643
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- Subjects must sign the informed consent document prior to performance of any study related procedure including the Screening procedure.
- Received kidney from; 1) living donor (n=12), 2)including the donor (n=12), brain-dead donor (n=12) and from donors after cardiac death (n=12).
- Males and females >= 18 years of age.

Exclusion Criteria

- Smoking and a current history of smoking in the past six months.
- Donor age < 16 and > 60 years.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Renal perfusion:<br /><br>1. Renal artery flow measured by Laser-Doppler flow probe.<br /><br>2. Microcirculatory perfusion measured by OPS imaging (parameters: volumetric<br /><br>blood flow, functional capillary density). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Kidney function:<br /><br>1. Dialysis dependency after transplantation.<br /><br>2. Area under the curve for serum creatinine concentration over time (14 days).<br /><br>3. Fractional excretion of sodium (14 days).<br /><br><br /><br>Inflammation: Serum cytokine concentrations (IFN-&gamma;, TNF-a, IL-6, IL-10, IL-17,<br /><br>IL-23).<br /><br><br /><br>Renal cellular injury: Urine NGAL and NAG concentrations.<br /><br><br /><br>Anti-oxidants: vitamin C, vitamin E, GSH/GSSG ratio, total anti-oxidant<br /><br>capacity.<br /><br><br /><br>Endothelial glycocalyx:<br /><br>1. Thickness measured by OPS imaging<br /><br>2. Renal arterio-venous differences in syndecan-1, heparin sulphate and<br /><br>hyaluronan concentrations.</p><br>