Hypotension Clinical Trial
Official title:
Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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