Comparison of Post- and Pre-dilutional Hemodiafiltration in Hemodialysis Patients

NCT03288285 | Completed DMC

• 1 other identifier: 106042
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodiafiltration (HDF) is a choice of treatment modalities for patients with end-stage renal disease. Hemodiafiltration, combining diffusion and convection, may increase removal of large and middle molecule uremic toxins comparing to conventional hemodialysis. The techniques of hemodiafiltration include pre-dilution and post-dilution according to the infusion site of substitution fluid. Post-dilution HDF is most widely used because of higher removal rate of uremic toxins. However, hemoconcentration and clotting of membrane limit its further clearance of toxins. Pre-dilution may preserve membrane permeability and maintain hemodynamic status. Although lower clearance of small molecule uremic toxins, one study in Japan showed survival benefits of pre-dilution HDF, comparing to post-dilution HDF. The aim of this study was to compare pre-dilution and post-dilution HDF in terms of their clinical and biological parameters and clearance of uremic toxins by using cross-over study design.

Conditions

Hemodiafiltration

Keywords

hemodiafiltration; pre-dilution; post-dilution; uremic toxins

Outcome Measures

Primary Outcomes (1)

• Removal of a wide spectrum of solutes

  The primary objective is to compare the removal of a wide spectrum of solutes such as middle and protein-bound molecules

  1 years

Secondary Outcomes (1)

• Intradialytic tolerance

  1 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hemodialysis (HD) patients

You may qualify if:

• stable patients end-stage renal disease who were older than 20 years and received thrice-weekly standard hemodialysis for more than 3 months were recruited.

You may not qualify if:

• active systemic disease, liver cirrhosis, malignancy, receiving immunosuppressive treatment, dialysis with temporal non-tunneled catheter, inadequate dialysis dose (kt/V\<1.2).

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

Study Sites (1)

Tungs' Taichung Metroharbour Hospital

Taichung, Taiwan

Location

Study Officials

• Chang-Hsu Chen, MD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 20, 2017
• Study Start: September 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: April 7, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

TW (1)