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Completed

NCT Number: NCT01749761

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

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Paul's Hospital Hemodialysis Unit

Vancouver, British Columbia, V6Z1Y6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BioLogic RR

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

Other names: BioLogics Comfort RR, B Braun software

Hemodialysis without biofeedback

Other

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

Other names: Hemodialysis

Primary outcomes

  1. intradialytic hypotension episodes

    Time frame: 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 outcomes

  1. urea clearance

    Time frame: 8 weeks

    Change in urea clearance

  2. Brain natriuretic peptide

    Time frame: 8 weeks

    change in BNP

  3. intradialytic hypotension (blood pressure criteria alone)

    Time frame: 8 weeks

    Reduction in the number of IDH episodes based on BP criteria alone

  4. Intradialytic symptoms

    Time frame: 8 weeks

    Reduction in the number of intradialytic symptoms

Other outcomes

  1. Oxygenation saturation

    Time frame: 8 weeks

    Reduction in the minimum 02 saturation achieved

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • B. Braun Medical Inc.
  • University of British Columbia

Registry information

Official study title

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

Acronym: BP-RIDH

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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