NCT03524846

Ascorbic Acid on Restenosis of Dysfunctional Hemodialysis Vascular Access

Effect of Ascorbic Acid Administration on Restenosis of Dysfunctional Hemodialysis Vascular

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To investigate the effect of ascorbic acid on angiographic restenosis after percutaneous transluminal angioplasty (PTA) for dysfunctional dialysis vascular access.

Detailed description

Vascular access dysfunction is the leading cause of treatment insufficiency or interruption among hemodialysis (HD) patients, and it is responsible for a large portion of the cost of any end-stage renal disease (ESRD) program. Intimal hyperplasia at the venous segment of vascular access is the characteristic lesion, which leads to dysfunction or failure of both arteriovenous fistulas (AVF) and prosthetic grafts (AVG). Although percutaneous transluminal angioplasty (PTA) is effective in treating these stenotic lesions, the effect seems not permanent and restenosis after PTA remains a major problem. A number of studies have examined the clinical, anatomical, and technical factors for restenosis, the causes of restenosis are still not fully understood.This highlights a possible role of non-traditional risk factors to explain the high restenosis rate at the venous segment of vascular access, which includes oxidative stress, inflammation, and endothelial dysfunction. Ascorbic acid (vitamin C) is a potent antioxidant used for a long time. Hemodialysis patients had been shown to be deficient in antioxidant defense, which resulted in increasing requirement of ascorbic acid supplement. Currently, intravenous 300-mg ascorbic acid supplementation three times a week after hemodialysis had been used to overcome erythropoietin resistance in patients with iron deficiency. Theoretically, ascorbic acid scavenges reactive oxygen species and reactive nitrogen species and may thereby prevent oxidative injuries. Investigators reported that administration of high dose ascorbic acid could prevent lipid peroxidation and oxidative DNA damage in patients with ESRD. In this study, the investigators investigated whether ascorbic acid could decrease venous restenosis after PTA for dysfunctional hemodialysis vascular access.

Conditions

• Hemodialysis Access Failure

Interventions

Type	Name	Description
DRUG	Ascorbic Acid 300 MG	Ascorbic acid 300 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.
DRUG	Ascorbic Acid 600 MG	Ascorbic acid 600 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.
DRUG	Normal saline	Normal saline was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2018-05-15
• Last updated: 2018-05-15