Ascorbic Acid on Restenosis of Dysfunctional Hemodialysis Vascular Access

NCT ID: NCT03524846

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ascorbic Acid 300 MG

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Ascorbic Acid 600 MG

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

Other Intervention Names

Vitamin C; Vitamin C

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: lead

Responsible Party

IRB of NTUH Hsin-Chu Branch

Secretary In Medical Affairs/Director of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chih-Cheng Wu, M.D.

Role: STUDY_DIRECTOR

Associate professor of Medicine, National Taiwan University, College of Medicine, Taipei, Taiwan

References

Tomoda H, Yoshitake M, Morimoto K, Aoki N. Possible prevention of postangioplasty restenosis by ascorbic acid. Am J Cardiol. 1996 Dec 1;78(11):1284-6. doi: 10.1016/s0002-9149(96)00613-3.

Reference Type: BACKGROUND

PMID: 8960592 (View on PubMed)

Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

Reference Type: DERIVED

PMID: 37916745 (View on PubMed)

Yang CW, Wu CC, Luo CM, Chuang SY, Chen CH, Shen YF, Tarng DC. A randomized feasibility study of the effect of ascorbic acid on post-angioplasty restenosis of hemodialysis vascular access (NCT03524846). Sci Rep. 2019 Jul 31;9(1):11095. doi: 10.1038/s41598-019-47583-w.

Reference Type: DERIVED

PMID: 31366980 (View on PubMed)

Other Identifiers

99G002

Identifier Type: -

Identifier Source: org_study_id