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临床试验/NCT03524846
NCT03524846已完成2 期

Effect of Ascorbic Acid Administration on Restenosis of Dysfunctional Hemodialysis Vascular

National Taiwan University Hospital Hsin-Chu Branch0 个研究点目标入组 93 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
93
主要终点
the extent of restenosis after angioplasty

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • clinical signs, i.e., decreased thrill, development of collateral veins, limb swelling, and prolonged bleeding from puncture sites, suggesting vascular access dysfunction
  • reduction of flow rate more than 25% from baseline
  • total access blood flow rate less than 500 mL/min by ultrasound dilution method
  • increased venous pressure during dialysis, as dynamic venous pressure exceeding threshold levels of 150 mmHg in AVF and 160 mmHg in AVG, respectively, under dialysis blood flow 250 ml/min for three consecutive times

排除标准

  • hospitalized for infection, heart failure, or acute coronary syndrome in recent 3 months
  • unable to comply with follow-up visits
  • already under ascorbic acid or other antioxidant supplements

研究组 & 干预措施

Ascorbic acid 300 mg

Active Comparator

Ascorbic acid 300 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.

干预措施: Ascorbic Acid 300 MG (Drug)

Ascorbic acid 600 mg

Active Comparator

Ascorbic acid 600 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.

干预措施: Ascorbic Acid 600 MG (Drug)

Placebo

Placebo Comparator

Normal saline was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.

干预措施: Normal saline (Drug)

结局指标

主要结局

the extent of restenosis after angioplasty

时间窗: 12 weeks

the extent of restenosis defined by the late loss of minimal vessel diameter and late loss of percentage stenosis at follow-up angiograms

次要结局

未报告次要终点

研究者

发起方
National Taiwan University Hospital Hsin-Chu Branch
申办方类型
Other
责任方
Principal Investigator
主要研究者

IRB of NTUH Hsin-Chu Branch

Secretary In Medical Affairs/Director of Nephrology

National Taiwan University Hospital Hsin-Chu Branch

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