NHS Greater Glasgow andClyde
Glasgow, G12 0XH, United Kingdom
NCT Number: NCT01862679
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Glasgow, G12 0XH, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline compared 8 week treatment point
Self-assessment by patient of hours/mins to full recovery after dialysis
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
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
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Time frame: Measured at baseline, and after 4 and 8 weeks of each treatment period
Time frame: : Measured at baseline, and after 4 and 8 weeks of each treatment period
NHS Greater Glasgow and Clyde
Other
Single Blind, Prospective, Randomised Comparative Study of High-flux Haemodialysis and Haemodiafiltration
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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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