NCT01749761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

10 months

First QC Date

December 12, 2012

Last Update Submit

June 14, 2014

Conditions

Hypotension

Keywords

IDH, intradialytic hypotension,hypotension on hemodialysis,hemodialysis,Blood pressure guided biofeedback

Outcome Measures

Primary Outcomes (1)

  • intradialytic hypotension episodes

    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

    By the end of the 8 week intervention period

Secondary Outcomes (4)

  • urea clearance

    8 weeks

  • Brain natriuretic peptide

    8 weeks

  • intradialytic hypotension (blood pressure criteria alone)

    8 weeks

  • Intradialytic symptoms

    8 weeks

Other Outcomes (1)

  • Oxygenation saturation

    8 weeks

Study Arms (2)

Hemodialysis without biofeedback

PLACEBO COMPARATOR

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

Other: BioLogic RR

BioLogic RR biofeedback

ACTIVE COMPARATOR

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

Other: Hemodialysis without biofeedback

Interventions

BioLogic RROTHER

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

Also known as: BioLogics Comfort RR, B Braun software
Hemodialysis without biofeedback
Hemodialysis without biofeedbackOTHER

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

Also known as: Hemodialysis
BioLogic RR biofeedback

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic hemodialysis patients
  • history of 3 of the last 12 runs with documented hypotension with symptoms or nursing interventions

You may not qualify if:

  • \<19 years
  • hemodiafiltration
  • expected switch in modality within next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.Paul's Hospital Hemodialysis Unit

Vancouver, British Columbia, V6Z1Y6, Canada

Location

MeSH Terms

Conditions

Hypotension

Interventions

Renal DialysisBiofeedback, Psychology

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption DetoxificationMind-Body TherapiesComplementary TherapiesBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Jennifer M MacRae, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 17, 2012

Study Start

January 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

CA(1)