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

This study is currently recruiting participants.
Verified March 2013 by University of Calgary
Sponsor:
Collaborators:
University of British Columbia
B. Braun Medical Inc.
Information provided by (Responsible Party):
Dr Jennifer MacRae, University of Calgary
ClinicalTrials.gov Identifier:
NCT01749761
First received: December 12, 2012
Last updated: March 23, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Hypotension
 Other: BioLogic RR
Other: Hemodialysis without biofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • intradialytic hypotension episodes [ Time Frame: By the end of the 8 week intervention period ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in urea clearance

  • Brain natriuretic peptide [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    change in BNP

  • intradialytic hypotension (blood pressure criteria alone) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Reduction in the number of IDH episodes based on BP criteria alone

  • Intradialytic symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Reduction in the number of intradialytic symptoms


Other Outcome Measures:
  • Oxygenation saturation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Reduction in the minimum 02 saturation achieved


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Hemodialysis without biofeedback
Patients will be randomized to receive hemodialysis without biofeedback for a period of 8 weeks.
 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 Name: BioLogics Comfort RR, B Braun software
Active Comparator: BioLogic RR biofeedback
Patients will receive 8 weeks of HD with BioLogic RR Blood pressure guided biofeedback.
 Other: Hemodialysis without biofeedback
patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks
Other Name: 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749761

Contacts
Contact: Jennifer MacRae, MD 403-944-8168 jennifer.macrae@albertahealthservices.ca

Locations
Canada, British Columbia
St.Paul's Hospital Hemodialysis Unit Recruiting
Vancouver, British Columbia, Canada, V6Z1Y6
Contact: Jennifer M MacRae     403-944-8168        
Sub-Investigator: Mercedeh Kiaii, MD            
Sponsors and Collaborators
University of Calgary
University of British Columbia
B. Braun Medical Inc.
Investigators
Principal Investigator: Jennifer M MacRae, MD University of Calgary
  More Information

No publications provided

Responsible Party: Dr Jennifer MacRae, Primary Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT01749761     History of Changes
Other Study ID Numbers: H12-02619
Study First Received: December 12, 2012
Last Updated: March 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
IDH, intradialytic hypotension,
hypotension on hemodialysis,
hemodialysis,
Blood pressure guided biofeedback

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013