High Versus Standard Volume Hemodiafiltration in Asia

Not Applicable

• Conditions: End-stage Renal Disease
• Interventions: Procedure: Standard Dose Online HDF; Procedure: High Dose Online HDF

• Registration Number: NCT02092194
• Lead Sponsor: Korean Hemodialysis Study Group

Brief Summary

Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The supported mechanism is the improved clearance of uremic toxins by convective transporter. However, It has not been elucidated which convection volume is optimal, especially in Asia. A total of 60 participants receiving conventional hemodialysis will be randomly assigned to receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes will include changes in the nutritional markers, inflammatory markers, and blood pressure from baseline to after treatment.

This would be the first multicenter prospective, randomized controlled trial to determine whether large convective volume improves the treatment efficacy in Korean patients undergoing post-dilution online HDF.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-19
• Last Update Submitted: 2014-03-19
• Study First Posted: 2014-03-20
• Last Update Posted: 2014-03-20
• Study Start: 2014-04
• Primary Completion: 2016-03
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients on thrice-weekly standard hemodialysis for > 3 months
• Patients with a vascular access capable of delivering consistently a high blood flow rates ( ≥ 300 mL/min)
• Patients willing to provide written informed consent.

Exclusion Criteria

• Patients with active infectious or uncontrolled inflammatory disorders
• Patients with any uncontrolled malignant disease
• Patients with recent major cardiovascular disease during the last 6 months
• Patients who are likely to receive kidney transplant within the following 1 year
• Patients whose life expectancy < 12 months
• Patients considered by investigator to have difficulty in participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Dose online HDF	Standard Dose Online HDF	Proposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
High Dose online HDF	High Dose Online HDF	Proposed target convection volume; 33-43 L/treatment (140-180 mL/min).

Primary Outcome Measures

Name	Time	Method
changes in the serum concentration of β2 microglobulin	between baseline and 24 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	24 weeks	C-reactive protein (CRP), interleukin-6, tumor necrosis factor-α.
Intradialytic hypotension	24 weeks	Number of episode of symptomatic hypotension
Quality of Life	baseline and 24 weeks after treatment	SF-36-K (Korean version)
Dialysis Adequacy	24 weeks	Kt/V by the single pool variable volume formula.
Nutritional status	24 weeks	normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA)

Trial Locations

Locations (6)

Yonsei University Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Gyeonggi-do, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Shamyook Medical Center; 🇰🇷 Seoul, Korea, Republic of