Ascorbic Acid on Restenosis of Dysfunctional Hemodialysis Vascular Access

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hemodialysis Access Failure

Clinical Trial Details

NCT number	NCT03524846
Study type	Interventional
Source	National Taiwan University Hospital Hsin-Chu Branch
Contact
Status	Completed
Phase	Phase 2
Start date	April 2011
Completion date	October 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03952819` - The Effects of Hemodialysis on Serum Sclerostin Levels
Active, not recruiting	`NCT04054128` - Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients	Phase 4
Recruiting	`NCT06034691` - Exploratory Research of PCSK9 Inhibitor on Patency of aAVF After PTA With PCB	N/A
Completed	`NCT03627884` - Outcomes of the Use of Sodium Bicarbonate (8.4%) Solution as a Catheter Lock Solution to Prevent Hemodialysis Catheter Loss Due to Lumen Clot Formation	Phase 4
Recruiting	`NCT06001827` - SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study	N/A
Recruiting	`NCT04285073` - Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.	N/A
Recruiting	`NCT05906550` - Flow Dysfunction of Hemodialysis Vascular Access	N/A
Not yet recruiting	`NCT04098159` - Role of Regular Surveillance on Maintenance of Patency of an Arteriovenous Access	N/A
Terminated	`NCT05228132` - The Pristine Post-Market Study	N/A
Recruiting	`NCT03365089` - Collateral Ligation in Failing Fistulas	N/A
Recruiting	`NCT04489849` - Apixaban for Prevention of Post-angioplasty Thrombosis of Hemodialysis Vascular Access	Phase 4
Recruiting	`NCT03140345` - Integrative HD Vascular Access Assessment	N/A
Enrolling by invitation	`NCT04381754` - Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Haemodialysis Arteriovenous Fistulas and Grafts.
Completed	`NCT03988270` - Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy	N/A
Recruiting	`NCT04502160` - The Northern Ireland Haemodialysis Vascular Access Database
Active, not recruiting	`NCT05418816` - SelfWrap-Assisted Arteriovenous Fistulas	N/A
Completed	`NCT04263116` - Balloon-Assisted Maturation of Autogenous Arteriovenous Fistulae	N/A
Completed	`NCT05081648` - Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention	N/A
Not yet recruiting	`NCT05096416` - Three-dimensional (3D) Printed Hemodialysis Vascular Model	N/A
Recruiting	`NCT04692636` - BP Variability on the Outcomes of Hemodialysis Vascular Access

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.