It is very common for hemodialysis patients to have problems with low blood pressure while on hemodialysis. Low blood pressure on dialysis is not a good thing and it is associated with an increased risk of death and hospitalizations. It might be possible to minimize or even prevent these low blood pressure episodes with a software that can be added to the dialysis machine which detects the patient's changes in blood pressure and automatically slows down how much fluid is being removed from the person. The investigators hypothesize that a blood pressure guided biofeedback system (called BioLogics RR) will result in a 30% reduction in the number of hypotensive episodes on hemodialysis.
This is a randomized cross over trial in which 30 chronic hemodialysis patients with a history of intradialytic hypotension, IDH will be randomized to receive either standard hemodialysis or hemodialysis with blood pressure guided biofeedback (BioLogics RR Comfort, B braun). After the initial period of 8 weeks patients will cross over to the other group for the final 8 weeks of the study. The primary outcome is the reduction in the number of IDH episodes associated with patient symptoms or nursing symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
25
Patients will be randomized to BP guided biofeedback arm which will entail regular hemodialysis with a software program turned on to allow frequent assessment of blood pressure and automated adjustments of the ultrafiltration rate based on these blood pressure measurements. The duration of this arm is 8 weeks
patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks
St.Paul's Hospital Hemodialysis Unit
Vancouver, British Columbia, Canada
intradialytic hypotension episodes
A 30% reduction in the frequency of HD sessions complicated by IDH. IDH is defined as a reduction in systolic BP of \> = 20 mmHg if the pre-dialysis BP is \>= 100 mmHg and with patient symptoms or nursing intervention. IDH is defined as a reduction in systolic BP of \>=10 mmHg if predialysis BP \< = 90mm Hg and with patient symptoms or nursing interventions
Time frame: By the end of the 8 week intervention period
urea clearance
Change in urea clearance
Time frame: 8 weeks
Brain natriuretic peptide
change in BNP
Time frame: 8 weeks
intradialytic hypotension (blood pressure criteria alone)
Reduction in the number of IDH episodes based on BP criteria alone
Time frame: 8 weeks
Intradialytic symptoms
Reduction in the number of intradialytic symptoms
Time frame: 8 weeks
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