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Status unknownNCT00532597Updated Sep 20, 2007

Effects of On-Line Hemodiafiltration(HDF) on Vascular Health in Chronic Hemodialysis Patients

A Phase 4 interventional study of On-line hemodiafiltration and Low flux hemodialysis in End Stage Renal Disease and Hemodialysis, sponsored by Eulji General Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-09-20.

Sponsored by Eulji General Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether on-line hemodiafiltration ameliorate the endothelial dysfunction compared with the low flux hemodialysis in end stage renal disease patients on maintenance hemodialysis.

Read the detailed description
  1. On-line hemodiafiltration(OL-HDF) is a technique that combines diffusion with convection in which the large substitution fluid is produced directly from the dialysate. It offers many advantages aside from its safe inflammatory profile, which is attributable to the use of ultrapure dialysate and highly biocompatible dialysis membranes. Due to an improved convective clearance, significantly increased removal of large or protein-bound uremic retention solutes can be achieved, with a potential benefit on cardiovascular morbidity and mortality.
  2. Endothelial dysfunction, almost universal in end stage renal disease, is important risk factor for cardiovascular events, and can be evaluated by brachial artery endothelium-dependent vasodilation (flow-mediated dilation) to reactive hyperemia following 5 min of forearm ischemia.
  3. The stable HD patients will receive 8-week treatment on OL-HDF or conventional low flux HD and then crossed over to opposite treatment arm. The FMD will be measured by one sonographer, and at the same time whole blood and serum will be sampled and stored for further analysis. The timepoint for measurement is 4-week interval after baseline evaluation.
02

Conditions studied

  • End Stage Renal Disease
  • Hemodialysis

Keywords

  • Vascular Endothelium-Dependent Relaxation
  • Hemodialysis
  • Hemodiafiltration
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's planned enrollment of 20 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

This is the only study on the registry with Eulji General Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • end stage renal disease on maintenance hemodialysis for more than 3 months

Exclusion criteria

Exclusion Criteria:

  • diagnosis of active cardiovascular diseases in 6 months
  • elevation of liver enzymes over two fold of upper normal limit in 3 months
  • admission for acute infection in 3 months
  • untreatable stenosis of vascular access
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    O

    Procedure: On-line hemodiafiltration

  • Active comparator
    L

    Procedure: Low flux hemodialysis

Interventions

  • ProcedureOn-line hemodiafiltration
  • ProcedureLow flux hemodialysis
06

What researchers measure

Primary outcomes

  1. endothelial dysfunction measured by flow-mediated vasodilation

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • Eulji General Hospital
    Seoul, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00532597
Lead sponsor
Eulji General Hospital
First posted
Sep 20, 2007
Start date
Apr 2007
Completion
Mar 2008 (estimated)
Last update
Sep 20, 2007

Study contacts

Young-Hwan Hwang, M.D.
Contact
ondahl@eulji.ac.kr
82-2-970-8457
Su-Ah Sung, M.D., PhD.
Contact
soi@eulji.ac.kr
82-2-970-8205
SuAh Sung, M.D.,PhD.
study chair · Department of Internal Medicine, College of Medicine, Eulji University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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