An interventional study of High-flux haemodialysis and Haemodiafiltration in End Stage Renal Disease, sponsored by NHS Greater Glasgow and Clyde. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-07.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Treatment
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:
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 100 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration
Other: High-flux haemodialysis · Procedure: Haemodiafiltration
8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis
Other: High-flux haemodialysis · Procedure: Haemodiafiltration
High-flux haemodialysis is the standard dialysis modality currently in use in the UK
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.
Change in the average time taken to fully recover post dialysis
Self-assessment by patient of hours/mins to full recovery after dialysis
Time frame: Baseline compared 8 week treatment point
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
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
Pre-dialysis serum concentrations of potassium
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of phosphate
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of vitamin B12.
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of PTH.
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of beta-2-microglobulin
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of betaine
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Pre-dialysis serum concentrations of interleukin-6
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Kt/V urea.
Time frame: : Measured at baseline, and after 4 and 8 weeks of each treatment period
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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NHS Greater Glasgow and Clyde