Randomised Study of High-flux Haemodialysis and Haemodiafiltration

End Stage Renal Disease Clinical Trial

Official title:

Single Blind, Prospective, Randomised Comparative Study of High-flux Haemodialysis and Haemodiafiltration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862679
• Other study ID #: GN12RE153
• Status: Completed
• Phase: N/A
• First received: April 22, 2013
• Last updated: June 6, 2016
• Start date: July 2013
• Est. completion date: March 2014

Study information

• Verified date: June 2016
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Other:
• High-flux haemodialysis
High-flux haemodialysis is the standard dialysis modality currently in use in the UK

Procedure:
• 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.

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow andClyde	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Pre-dialysis serum concentrations of potassium		Measured at baseline, and after 4 and 8 weeks of each treatment period	No
Secondary	Pre-dialysis serum concentrations of phosphate		Measured at baseline, and after 4 and 8 weeks of each treatment period	No
Secondary	Pre-dialysis serum concentrations of vitamin B12.		Measured at baseline, and after 4 and 8 weeks of each treatment period	No
Secondary	Pre-dialysis serum concentrations of PTH.		Measured at baseline, and after 4 and 8 weeks of each treatment period	No
Secondary	Pre-dialysis serum concentrations of beta-2-microglobulin		Measured at baseline, and after 4 and 8 weeks of each treatment period	No
Secondary	Pre-dialysis serum concentrations of betaine		Measured at baseline, and after 4 and 8 weeks of each treatment period	No
Secondary	Pre-dialysis serum concentrations of interleukin-6		Measured at baseline, and after 4 and 8 weeks of each treatment period	No
Secondary	Kt/V urea.		: Measured at baseline, and after 4 and 8 weeks of each treatment period	No