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Hypotension | Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension

Hypotension research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - chronic hemodialysis patients - history of 3 of the last 12 runs with documented hypotension with symptoms or nursing interventions Exclusion Criteria: - <19 years - hemodiafiltration - expected switch in modality within next 6 months

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypotension

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:BioLogic RRPatients 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

Other:Hemodialysis without biofeedbackpatients will be randomized to Standard HD (without biofeedback technology) for 8 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Hemodialysis without biofeedbackPatients will be randomized to receive hemodialysis without biofeedback for a period of 8 weeks.

BioLogic RR biofeedbackPatients will receive 8 weeks of HD with BioLogic RR Blood pressure guided biofeedback.

Study Status

Completed

Start Date: January 2013

Completed Date: December 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: intradialytic hypotension episodes

Secondary Outcome: urea clearance

Study sponsors, principal investigator, and references

Principal Investigator: Jennifer M MacRae, MD

Lead Sponsor: University of Calgary

Collaborator: University of British Columbia

More information:https://clinicaltrials.gov/show/NCT01749761

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