Clinical trial NCT01862679: Randomised Study of High-flux Haemodialysis and Haemodiafiltration
Official title: Single Blind, Prospective, Randomised Comparative Study of High-flux Haemodialysis and Haemodiafiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the average time taken to fully recover post dialysis
timeFrame: Baseline compared 8 week treatment point
Secondary outcomes:
measure: Number of symptomatic hypotension events
timeFrame: 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
measure: Number of dialysis circuit clotting events
timeFrame: 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
measure: Pre-dialysis serum concentrations of potassium
timeFrame: Measured at baseline, and after 4 and 8 weeks of each treatment period
measure: Pre-dialysis serum concentrations of phosphate
timeFrame: Measured at baseline, and after 4 and 8 weeks of each treatment period
measure: Pre-dialysis serum concentrations of vitamin B12.
timeFrame: Measured at baseline, and after 4 and 8 weeks of each treatment period
measure: Pre-dialysis serum concentrations of PTH.
timeFrame: Measured at baseline, and after 4 and 8 weeks of each treatment period
measure: Pre-dialysis serum concentrations of beta-2-microglobulin
timeFrame: Measured at baseline, and after 4 and 8 weeks of each treatment period
measure: Pre-dialysis serum concentrations of betaine
timeFrame: Measured at baseline, and after 4 and 8 weeks of each treatment period
measure: Pre-dialysis serum concentrations of interleukin-6
timeFrame: Measured at baseline, and after 4 and 8 weeks of each treatment period
measure: Kt/V urea.
timeFrame: : Measured at baseline, and after 4 and 8 weeks of each treatment period
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow andClyde
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Robert MacTier, Md, FRCP
role: STUDY_DIRECTOR
References: