Randomised Study of High-flux Haemodialysis and Haemodiafiltration

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Other: High-flux haemodialysis; Procedure: Haemodiafiltration

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G12 0XH
    • NHS Greater Glasgow andClyde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 8 weeks HF haemodialysis / 8 weeks HD-filtration; 8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration	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.
Experimental: 8 weeks HD-filtration /8 weeks HF haemodialysis; 8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Investigators: Study Director: Robert MacTier, Md, FRCP, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: GN12RE153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No