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Completed

NCT Number: NCT01862679

Randomised Study of High-flux Haemodialysis and Haemodiafiltration

The most common forms of renal replacement therapy currently in use are high flux haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar to the patient, there are important differences in what happens to the blood as it travels through the dialysis machine.

During HDF, the machine controls hydrostatic pressure across the dialyser to remove additional water together with toxins from the blood and this fluid volume is continually replaced with an ultra-pure solution. HDF has a theoretical advantage removing more waste substances, especially larger molecules, from the blood than HF-HD which may be of benefit to the patient in the medium to long term.Despite the theoretical advantages, trials have so far been unable to find any significant difference in death rates or the development of health problems among patients on HDF or HF-HD.

It is therefore important to examine other factors which may help doctors and patients to decide which treatment to use. The investigators have designed a study which aims to answer three main questions:

1. Does HDF make patients feel better? 2. Is blood pressure more stable on HDF in comparison with HF-HD? 3. Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD?

The investigators will do this by randomly assigning patients on HF-HD to receive 2 months of either HF-HD or HDF with as equivalent treatment prescriptions as possible and without the patient knowing which treatment they are receiving. After two months the patients will switch to the alternative form of dialysis for a further two months. During the study the investigators will ask the patients how long it took them to recover from the preceding session of dialysis, assess the frequency of symptomatic low blood pressure and also perform blood tests at set intervals to measure specific blood parameters.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Receiving HF-HD for at least 3 months
  • Reliable vascular access (i.e. use of the same fistula, graft or tunnelled central venous catheter for at least 1 month)
  • Aged 18 or older

Exclusion criteria

  • Currently receiving HDF
  • Emergency hospital admissions within the preceding 4 weeks
  • Life expectancy less than 6 months
  • Neoplasia
  • Unable to give informed consent
  • Unable to perform QoL questionnaire or self report recovery post-dialysis time

Treatment and study plan

High-flux haemodialysis

Other

High-flux haemodialysis is the standard dialysis modality currently in use in the UK

Haemodiafiltration

Procedure

During Haemodiafiltration, the dialysis machine removes more water from the blood than during "normal" hemodialysis. The additional liquid is continually replaced with an ultra-pure solution. Thus, the machine exchanges a high volume of fluid during treatment and removes the liquid together with toxins from the blood.

Primary outcomes

  1. Change in the average time taken to fully recover post dialysis

    Time frame: Baseline compared 8 week treatment point

    Self-assessment by patient of hours/mins to full recovery after dialysis

Secondary outcomes

  1. Number of symptomatic hypotension events

    Time frame: Number of events noted by nurse at each dialysis session in each of the two arms of the study. Each arm= 3 sessions per week for 8 weeks

  2. Number of dialysis circuit clotting events

    Time frame: Number of events noted by nurse at each dialysis session in each of the two arms of the study. Each arm= 3 sessions per week for 8 weeks

  3. Pre-dialysis serum concentrations of potassium

    Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period

  4. Pre-dialysis serum concentrations of phosphate

    Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period

  5. Pre-dialysis serum concentrations of vitamin B12.

    Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period

  6. Pre-dialysis serum concentrations of PTH.

    Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period

  7. Pre-dialysis serum concentrations of beta-2-microglobulin

    Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period

  8. Pre-dialysis serum concentrations of betaine

    Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period

  9. Pre-dialysis serum concentrations of interleukin-6

    Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period

  10. Kt/V urea.

    Time frame: : Measured at baseline, and after 4 and 8 weeks of each treatment period

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Registry information

Official study title

Single Blind, Prospective, Randomised Comparative Study of High-flux Haemodialysis and Haemodiafiltration

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 24, 2013
Registry last updated
Jun 7, 2016

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.

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