Skip to main content
OpenTrials
Completed

NCT Number: NCT03288285

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tungs' Taichung Metroharbour Hospital

Taichung, Taiwan

About this study

  • Study design: randomly assigned, cross-over study.
  • Patient number: 60.
  • Inclusion criteria: 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.
  • Exclusion criteria: active systemic disease, liver cirrhosis, active malignancy, receiving immunosuppressive treatment, dialysis with temporal non-tunneled catheter, inadequate dialysis dose (single-pooled Kt/V<1.2).
  • Methods:

Prior to randomization, a Charlson Comorbidity Index score and baseline characteristics are recorded for each patient. Each patient who received HDF prior to study will received one-month high-flux hemodialysis with target single-pooled Kt/V>1.2 for washout. The baseline characteristics of each patient including dialyzer, dialysis time, blood flow, dialysate flow, replacement volume, pre- and post-dialysis blood pressure and body weight were recorded. The follow-up laboratory data will also be collected: predialysis C-reactive protein, blood urea nitrogen, creatinine, bicarbonate, sodium, potassium, uric acid, albumin, calcium, phosphate, intact parathyroid hormone, β2-microglobulin, prolactin, fibroblast growth factor 23, α1-microglobulin, indoxyl sulfate, p-cresol sulfate, advance oxidation protein products, advance glycation product, percentage of proinflammatory monocytes; interleukin-6, tumor necrosis factor-α, hematocrit, transferrin saturation and ferritin. Urea kinetics including kt/V, Urea reduction ratio and normalized protein catabolic rate are calculated. We also used Physical Symptoms Distress Scale for life quality measurement.

After randomization, two group received standard prescription of pre- and post-dilution HDF. The prescribed convective volume per treatment of post-dilution mode is based on blood flow, filtration fraction and hematocrit to achieved current recommendation of 23 liter/1.73m2. The convective volume of pre-dilution mode will be at least twice higher than the desired dose in post-dilution mode for each patient. After 3-month stable hemodiafiltration, parameters mentioned above will also be checked. Two group will be switched for another 3-month course and then switch again. The total following time is 12 months.

  • Outcome: The primary objective is to compare the removal of a wide spectrum of solutes such as middle and protein-bound molecules. Secondary outcomes are intradialytic tolerance, including intradialytic hypotension, cramps and arrhythmia, and life quality measurements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Removal of a wide spectrum of solutes

    Time frame: 1 years

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

Secondary outcomes

  1. Intradialytic tolerance

    Time frame: 1 years

    intradialytic tolerance including symptomatic hypotension, cramps, headache, nutrition, and inflammatory status.

Sponsors and collaborators

Lead sponsor

Tungs' Taichung Metroharbour Hospital

Other

Registry information

Official study title

Effects of Post- and Pre-dilutional Hemodiafiltration on Patients With End-stage Renal Disease

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 20, 2017
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.