NCT01749761

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

Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hypotension

Interventions

Type	Name	Description
OTHER	BioLogic RR	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
OTHER	Hemodialysis without biofeedback	patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2012-12-17
• Last updated: 2014-06-17

Locations

1 site across 1 country: Canada