Randomised Study of High-flux Haemodialysis and Haemodiafiltration
NCT ID: NCT01862679
Last Updated: 2016-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2013-07-31
2014-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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8 weeks HF haemodialysis / 8 weeks HD-filtration
8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration
High-flux haemodialysis
High-flux haemodialysis is the standard dialysis modality currently in use in the UK
Haemodiafiltration
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.
8 weeks HD-filtration /8 weeks HF haemodialysis
8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis
High-flux haemodialysis
High-flux haemodialysis is the standard dialysis modality currently in use in the UK
Haemodiafiltration
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.
Interventions
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High-flux haemodialysis
High-flux haemodialysis is the standard dialysis modality currently in use in the UK
Haemodiafiltration
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Robert MacTier, Md, FRCP
Role: STUDY_DIRECTOR
NHS Greater Glasgow and Clyde
Locations
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NHS Greater Glasgow andClyde
Glasgow, , United Kingdom
Countries
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Other Identifiers
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GN12RE153
Identifier Type: -
Identifier Source: org_study_id
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