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Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension (BP-RIDH)

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BioLogic RR
Hemodialysis without biofeedback
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring IDH, intradialytic hypotension,, hypotension on hemodialysis,, hemodialysis,, Blood pressure guided biofeedback

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St.Paul's Hospital Hemodialysis Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Hemodialysis without biofeedback

BioLogic RR biofeedback

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2012
Last Updated
June 14, 2014
Sponsor
University of Calgary
Collaborators
University of British Columbia, B. Braun Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01749761
Brief Title
Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension
Acronym
BP-RIDH
Official Title
Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
University of British Columbia, B. Braun Medical Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
IDH, intradialytic hypotension,, hypotension on hemodialysis,, hemodialysis,, Blood pressure guided biofeedback

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemodialysis without biofeedback
Arm Type
Placebo Comparator
Arm Description
Patients will be randomized to receive hemodialysis without biofeedback for a period of 8 weeks.
Arm Title
BioLogic RR biofeedback
Arm Type
Active Comparator
Arm Description
Patients will receive 8 weeks of HD with BioLogic RR Blood pressure guided biofeedback.
Intervention Type
Other
Intervention Name(s)
BioLogic RR
Other Intervention Name(s)
BioLogics Comfort RR, B Braun software
Intervention Description
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
Intervention Name(s)
Hemodialysis without biofeedback
Other Intervention Name(s)
Hemodialysis
Intervention Description
patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks
Primary Outcome Measure Information:
Title
intradialytic hypotension episodes
Description
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
Time Frame
By the end of the 8 week intervention period
Secondary Outcome Measure Information:
Title
urea clearance
Description
Change in urea clearance
Time Frame
8 weeks
Title
Brain natriuretic peptide
Description
change in BNP
Time Frame
8 weeks
Title
intradialytic hypotension (blood pressure criteria alone)
Description
Reduction in the number of IDH episodes based on BP criteria alone
Time Frame
8 weeks
Title
Intradialytic symptoms
Description
Reduction in the number of intradialytic symptoms
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Oxygenation saturation
Description
Reduction in the minimum 02 saturation achieved
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer M MacRae, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Paul's Hospital Hemodialysis Unit
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada

12. IPD Sharing Statement

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

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