Randomised Study of High-flux Haemodialysis and Haemodiafiltration
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High-flux haemodialysis
Haemodiafiltration
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
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
Sites / Locations
- NHS Greater Glasgow andClyde
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
8 weeks HF haemodialysis / 8 weeks HD-filtration
8 weeks HD-filtration /8 weeks HF haemodialysis
Arm Description
8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration
8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis
Outcomes
Primary Outcome Measures
Change in the average time taken to fully recover post dialysis
Self-assessment by patient of hours/mins to full recovery after dialysis
Secondary Outcome Measures
Number of symptomatic hypotension events
Number of dialysis circuit clotting events
Pre-dialysis serum concentrations of potassium
Pre-dialysis serum concentrations of phosphate
Pre-dialysis serum concentrations of vitamin B12.
Pre-dialysis serum concentrations of PTH.
Pre-dialysis serum concentrations of beta-2-microglobulin
Pre-dialysis serum concentrations of betaine
Pre-dialysis serum concentrations of interleukin-6
Kt/V urea.
Full Information
NCT ID
NCT01862679
First Posted
April 22, 2013
Last Updated
June 6, 2016
Sponsor
NHS Greater Glasgow and Clyde
1. Study Identification
Unique Protocol Identification Number
NCT01862679
Brief Title
Randomised Study of High-flux Haemodialysis and Haemodiafiltration
Official Title
Single Blind, Prospective, Randomised Comparative Study of High-flux Haemodialysis and Haemodiafiltration
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
Does HDF make patients feel better?
Is blood pressure more stable on HDF in comparison with HF-HD?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
8 weeks HF haemodialysis / 8 weeks HD-filtration
Arm Type
Experimental
Arm Description
8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration
Arm Title
8 weeks HD-filtration /8 weeks HF haemodialysis
Arm Type
Experimental
Arm Description
8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis
Intervention Type
Other
Intervention Name(s)
High-flux haemodialysis
Intervention Description
High-flux haemodialysis is the standard dialysis modality currently in use in the UK
Intervention Type
Procedure
Intervention Name(s)
Haemodiafiltration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the average time taken to fully recover post dialysis
Description
Self-assessment by patient of hours/mins to full recovery after dialysis
Time Frame
Baseline compared 8 week treatment point
Secondary Outcome Measure Information:
Title
Number of symptomatic hypotension events
Time Frame
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
Title
Number of dialysis circuit clotting events
Time Frame
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
Title
Pre-dialysis serum concentrations of potassium
Time Frame
Measured at baseline, and after 4 and 8 weeks of each treatment period
Title
Pre-dialysis serum concentrations of phosphate
Time Frame
Measured at baseline, and after 4 and 8 weeks of each treatment period
Title
Pre-dialysis serum concentrations of vitamin B12.
Time Frame
Measured at baseline, and after 4 and 8 weeks of each treatment period
Title
Pre-dialysis serum concentrations of PTH.
Time Frame
Measured at baseline, and after 4 and 8 weeks of each treatment period
Title
Pre-dialysis serum concentrations of beta-2-microglobulin
Time Frame
Measured at baseline, and after 4 and 8 weeks of each treatment period
Title
Pre-dialysis serum concentrations of betaine
Time Frame
Measured at baseline, and after 4 and 8 weeks of each treatment period
Title
Pre-dialysis serum concentrations of interleukin-6
Time Frame
Measured at baseline, and after 4 and 8 weeks of each treatment period
Title
Kt/V urea.
Time Frame
: Measured at baseline, and after 4 and 8 weeks of each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert MacTier, Md, FRCP
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Study Director
Facility Information:
Facility Name
NHS Greater Glasgow andClyde
City
Glasgow
ZIP/Postal Code
G12 0XH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Randomised Study of High-flux Haemodialysis and Haemodiafiltration
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