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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 weeks HF haemodialysis / 8 weeks HD-filtration | Experimental | 8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration |
|
| 8 weeks HD-filtration /8 weeks HF haemodialysis | Experimental | 8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flux haemodialysis | Other | High-flux haemodialysis is the standard dialysis modality currently in use in the UK |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the average time taken to fully recover post dialysis | Self-assessment by patient of hours/mins to full recovery after dialysis | Baseline compared 8 week treatment point |
| Measure | Description | Time Frame |
|---|---|---|
| Number of symptomatic hypotension events | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert MacTier, Md, FRCP | NHS Greater Glasgow and Clyde | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Greater Glasgow andClyde | Glasgow | G12 0XH | United Kingdom |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D017583 | Hemodiafiltration |
| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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| 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. |
|
| Pre-dialysis serum concentrations of potassium | Measured at baseline, and after 4 and 8 weeks of each treatment period |
| Pre-dialysis serum concentrations of phosphate | Measured at baseline, and after 4 and 8 weeks of each treatment period |
| Pre-dialysis serum concentrations of vitamin B12. | Measured at baseline, and after 4 and 8 weeks of each treatment period |
| Pre-dialysis serum concentrations of PTH. | Measured at baseline, and after 4 and 8 weeks of each treatment period |
| Pre-dialysis serum concentrations of beta-2-microglobulin | Measured at baseline, and after 4 and 8 weeks of each treatment period |
| Pre-dialysis serum concentrations of betaine | Measured at baseline, and after 4 and 8 weeks of each treatment period |
| Pre-dialysis serum concentrations of interleukin-6 | Measured at baseline, and after 4 and 8 weeks of each treatment period |
| Kt/V urea. | : Measured at baseline, and after 4 and 8 weeks of each treatment period |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006440 |
| Hemofiltration |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |