A randomized trial of liposomal prednisolone (LIPMAT) to enhance radiocephalic fistula maturation: a pilot study

Abstract

INTRODUCTION: Maturation failure of radiocephalic arteriovenous fistulas (RCAVF) is a significant clinical issue. Vascular inflammation after AVF surgery is associated with non-maturation.

OBJECTIVE: To evaluate whether liposomal prednisolone improves RCAVF maturation in end-stage renal disease (ESRD) patients.

DESIGN: The LIPMAT-study was a multi-center, double-blind, 1:1 randomized, placebo-controlled trial. MATERIALS AND METHODS: Subjects were enrolled after RCAVF creation and treated with placebo or 150 mg of liposomal prednisolone at days 1 and 15 after AVF surgery. The primary end point was the juxta-anastomotic diameter of the cephalic vein at 6 weeks after surgery. Secondary end points were the diameter of the cephalic vein, brachial and radial artery at 6 weeks and 3 months after surgery as well as AVF flow and functional use for hemodialysis. Adverse events were compared to assess safety. RESULTS: 29 subjects were included of which 13 received placebo and 16 received liposomal prednisolone. The juxta-anastomitic cephalic vein diameter at 6 weeks was 3.9 mm (95% confidence interval 2.7 – 5.8 mm) in the placebo group and 3.7 mm (95% confidence interval 3.0 – 5.3 mm) in the liposomal prednisolone group (p=0.88). No significant differences in secondary end point parameters were observed. Treatment of end-stage renal disease patients with liposomal prednisolone was not associated with significant side effects. CONCLUSION: Liposomal prednisolone treatment of ESRD patients was safe, but did not result in enhanced RCAVF maturation.