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

End Stage Renal Disease Clinical Trial

Official title:

Effects of On-Line Hemodiafiltration(HDF) on Endothelial Dysfunction in Chronic Hemodialysis Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00532597
• Other study ID #: EMCIRB 07-01
• Status: Unknown status
• Phase: Phase 4
• First received: September 19, 2007
• Last updated: September 19, 2007
• Start date: April 2007
• Est. completion date: March 2008

Study information

• Verified date: September 2007
• Source: Eulji General Hospital
• Contact: Young-Hwan Hwang, M.D.
• Phone: 82-2-970-8457
• Email: ondahl[@]eulji.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic

Intervention

Procedure:
• On-line hemodiafiltration

• Low flux hemodialysis

Locations

Country	Name	City	State
Korea, Republic of	Eulji General Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eulji General Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial dysfunction measured by flow-mediated vasodilation		4 months