Last updated on February 2018

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

Brief description of study

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.

Detailed Study Description

  1. Study design: randomly assigned, cross-over study.
  2. Patient number: 60.
  3. 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.
  4. 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).
  5. 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,
     2-microglobulin, prolactin, fibroblast growth factor 23, 1-microglobulin, indoxyl
     sulfate, p-cresol sulfate, advance oxidation protein products, advance glycation
     product, percentage of proinflammatory monocytes; interleukin-6, tumor necrosis
     factor-, 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.

6. 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

Clinical Study Identifier: NCT03288285

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Recruitment Status: Open

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