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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01862679
Other study ID # GN12RE153
Secondary ID
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


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
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