Ascorbic Acid on Restenosis of Dysfunctional Hemodialysis Vascular Access

NCT03524846 | Completed Phase 2

• 1 other identifier: 99G002
• Study Type: interventional
• Target: 93
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hemodialysis Access Failure

Keywords

Ascorbic acid; hemodialysis vascular access; restenosis

Outcome Measures

Primary Outcomes (1)

• the extent of restenosis after angioplasty

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

  12 weeks

Study Arms (3)

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.

Drug: Ascorbic Acid 300 MG

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.

Drug: Ascorbic Acid 600 MG

Placebo

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Ascorbic Acid 300 MG DRUG

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

Also known as: Vitamin C

Ascorbic acid 300 mg

Ascorbic Acid 600 MG DRUG

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

Also known as: Vitamin C

Ascorbic acid 600 mg

Normal saline DRUG

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

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Related Publications (3)

• 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.

  PMID: 8960592 BACKGROUND

• 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.

  PMID: 37916745 DERIVED

• 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.

  PMID: 31366980 DERIVED

MeSH Terms

Interventions

Ascorbic Acid; Saline Solution

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chih-Cheng Wu, M.D.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Secretary In Medical Affairs/Director of Nephrology

Model Details: This was a prospective randomized, single-blind, placebo-controlled study

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 15, 2018
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share