Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension (BP-RIDH)

University of Calgary

Status: Completed

Conditions: Hypotension

Treatments: Other: Hemodialysis without biofeedback; Other: BioLogic RR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01749761

H12-02619

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups, including a placebo group

Hemodialysis without biofeedback

Placebo Comparator group

Description:

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

Treatment:

Other: BioLogic RR

BioLogic RR biofeedback

Active Comparator group

Description:

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

Treatment:

Other: Hemodialysis without biofeedback