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

NCT ID: NCT01749761

Last Updated: 2014-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-12-31

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.

Conditions

Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hemodialysis without biofeedback

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

Group Type: PLACEBO_COMPARATOR

BioLogic RR

Intervention Type: OTHER

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

BioLogic RR biofeedback

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

Group Type: ACTIVE_COMPARATOR

Hemodialysis without biofeedback

Intervention Type: OTHER

patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks

Interventions

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

Intervention Type: OTHER

Hemodialysis without biofeedback

patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks

Intervention Type: OTHER

Other Intervention Names

BioLogics Comfort RR, B Braun software; Hemodialysis

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

B. Braun Medical Inc.

INDUSTRY

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr Jennifer MacRae

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer M MacRae, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

St.Paul's Hospital Hemodialysis Unit

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H12-02619

Identifier Type: -

Identifier Source: org_study_id