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

NCT01749761 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-06-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • B. Braun Medical Inc.

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • Jennifer M MacRae, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01749761 on ClinicalTrials.gov