Hemodiafiltration Versus Hemodialysis in Older People
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age85+
SponsorAUB Santé
About this trial
This study will compare the impact of two hemodialysis techniques on fatigue and post-dialysis recovery time in patients aged 85 years and older. These two techniques are high-flux hemodialysis (HD) and hemodiafiltration (HDF).
Patients will receive the treatment over two periods: if period 1 is HD then period 2 will be HDF. Every patient will be his/her own control, this is why it is called cross-over. Each period will last three months. Between the two periods, patients will receive a traditional low-flux hemodialysis.
These two techniques are widely used worldwide and their side-effects are well-known and do not put the patients at risk. HDF has been shown to improve survival in patients with a mean age of 58 years. But a previous study from the investigators' group showed that HDF causes a prolonged recovery time in older patients. This randomized trial aims to elucidate this question.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed and dated informed consent
Age >84 years
Diagnosed with kidney failure
On maintenance hemodialysis >3months
Disqualifiers
Patients with cognitive impairment (assessed with a mini-test if needed)
Hospitalized at inclusion
Have difficulties with French speaking
Terminally ill with life expectancy<3 months
Trial design
Design model
Crossover
Treatments tested in this trial
High-flux hemodialysis
Other interventionHigh-flux hemodialysis removes small and middle molecular solutes through the mechanism of diffusion.
Hemodiafiltration
Other interventionHemodiafiltration removes solutes using convection which allows for more epuration of middle molecular solutes.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Sequence 1: HD HDFExperimental treatment 2 interventions
Group B: Sequence 2: HDF HDExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in dialysis recovery time
Time in minutes that the patient needs after dialysis to recover energy
Time frame
Three monthsSecondary outcomes
1
Change in fatigue score
Fatigue will be assessed using the Standardized Outcomes in Nephrology (SONG) fatigue scale: from 0 to 9, higher meaning worse outcomes.
Time frame
Three months2
Change in STS-30
The number of stand-to-sit over 30 seconds will be recorded. The higher the better outcome.
Time frame
Three months3
Change in SF-12 scores
Quality of life scale (12 items), from 0 to 100, the higher the better outcome.
Time frame
Three months4
Number of episodes of of symptomatic hypotension
Drop in blood pressure with symptoms
Time frame
Three months Source ClinicalTrials.gov