Randomised Study of High-flux Haemodialysis and Haemodiafiltration

NCT01862679 | Completed

• 1 other identifier: GN12RE153
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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:

1. 1.Does HDF make patients feel better?
2. 2.Is blood pressure more stable on HDF in comparison with HF-HD?
3. 3.Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD?

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

8 weeks HF haemodialysis / 8 weeks HD-filtration

EXPERIMENTAL

8 weeks high-flux haemodialysis followed by 8 weeks haemodiafiltration

Other: High-flux haemodialysis; Procedure: Haemodiafiltration

8 weeks HD-filtration /8 weeks HF haemodialysis

EXPERIMENTAL

8 weeks haemodiafiltration followed by 8 weeks high-flux haemodialysis

Other: High-flux haemodialysis; Procedure: Haemodiafiltration

Interventions

High-flux haemodialysis OTHER

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

8 weeks HD-filtration /8 weeks HF haemodialysis; 8 weeks HF haemodialysis / 8 weeks HD-filtration

Haemodiafiltration PROCEDURE

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.

8 weeks HD-filtration /8 weeks HF haemodialysis; 8 weeks HF haemodialysis / 8 weeks HD-filtration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

NHS Greater Glasgow andClyde

Glasgow, G12 0XH, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Hemodiafiltration

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Hemofiltration; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Robert MacTier, Md, FRCP

  NHS Greater Glasgow and Clyde

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: May 24, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

GB (1)