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

Not Applicable

Completed

• Conditions: Hypotension
• Interventions: Other: BioLogic RR; Other: Hemodialysis without biofeedback

• Registration Number: NCT01749761
• Lead Sponsor: University of Calgary

Brief 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.

Study Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Study Start: 2013-01
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-14
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hemodialysis without biofeedback	BioLogic RR	Patients will be randomized to receive hemodialysis without biofeedback for a period of 8 weeks.
BioLogic RR biofeedback	Hemodialysis without biofeedback	Patients will receive 8 weeks of HD with BioLogic RR Blood pressure guided biofeedback.

Primary Outcome Measures

Name	Time	Method
intradialytic hypotension episodes	By the end of the 8 week intervention period	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

Secondary Outcome Measures

Name	Time	Method
urea clearance	8 weeks	Change in urea clearance
Brain natriuretic peptide	8 weeks	change in BNP
intradialytic hypotension (blood pressure criteria alone)	8 weeks	Reduction in the number of IDH episodes based on BP criteria alone
Intradialytic symptoms	8 weeks	Reduction in the number of intradialytic symptoms

Trial Locations

Locations (1)

St.Paul's Hospital Hemodialysis Unit; 🇨🇦 Vancouver, British Columbia, Canada