Randomised Study of High-flux Haemodialysis and Haemodiafiltration

NHS Trust

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Procedure: Haemodiafiltration; Other: High-flux haemodialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01862679

GN12RE153

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

8 weeks HF haemodialysis / 8 weeks HD-filtration

Experimental group

Description:

8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration

Treatment:

Procedure: Haemodiafiltration

Other: High-flux haemodialysis

8 weeks HD-filtration /8 weeks HF haemodialysis

Experimental group

Description:

8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis

Treatment:

Procedure: Haemodiafiltration

Other: High-flux haemodialysis