This study will investigate if liposomal prednisolone is effective in promoting arteriovenous fistula (AVF) maturation when administered to human subjects after surgical creation of a radio-cephalic AVF.
AVFs are the preferred means of vascular access for maintenance hemodialysis. Nonmaturation occurs in 30-50% of cases, with highest rates in radio-cephalic fistulas. Inflammatory cytokines are involved in this process of nonmaturation. By suppressing inflammation, corticosteroids might promote maturation, but have significant systemic side effects. Liposomal prednisolone has a long circulation time and targets inflamed tissue with low systemic concentrations and limited side effects. In an animal study, it was demonstrated to promote AVF maturation. At present, no drug therapy aimed at improving shunt maturation is available. This study will investigate if liposomal prednisolone is effective in promoting AVF maturation when administered to human subjects after surgical creation of a radio-cephalic AVF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Liposomal prednisolone
0.9% normal saline
Leiden University Medical Center
Leiden, South Holland, Netherlands
Cephalic vein diameter
Echographic measurement of the diameter of the cephalic vein, six weeks after surgical creation of the radiocephalic shunt.
Time frame: 6 weeks after surgical creation of the radiocephalic shunt.
Cephalic vein diameter
Echographic measurement of the diameter of the cephalic vein, three months after surgical creation of the radiocephalic shunt.
Time frame: 3 months after surgical creation of the radiocephalic shunt.
Radial artery diameter
Echographic measurement of the diameter of the radial artery, six weeks after surgical creation of the radiocephalic shunt.
Time frame: 6 weeks after surgical creation of the radiocephalic shunt.
Radial artery diameter
Echographic measurement of the diameter of the radial artery, three months after surgical creation of the radiocephalic shunt.
Time frame: 3 months after surgical creation of the radiocephalic shunt.
Radial artery flow.
Echographic measurement of the flow of the radial artery, six weeks after surgical creation of the radiocephalic shunt.
Time frame: 6 weeks after surgical creation of the radiocephalic shunt.
Radial artery flow.
Echographic measurement of the flow of the radial artery, three months after surgical creation of the radiocephalic shunt.
Time frame: 3 months after surgical creation of the radiocephalic shunt.
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