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

December 12, 2012
March 23, 2013
January 2013
November 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01749761 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Oxygenation saturation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Reduction in the minimum 02 saturation achieved
Same as current
 
Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension
Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Hypotension
  • 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
  • Other: Hemodialysis without biofeedback
    patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks
    Other Name: Hemodialysis
  • Placebo Comparator: Hemodialysis without biofeedback
    Patients will be randomized to receive hemodialysis without biofeedback for a period of 8 weeks.
    Intervention: Other: BioLogic RR
  • Active Comparator: BioLogic RR biofeedback
    Patients will receive 8 weeks of HD with BioLogic RR Blood pressure guided biofeedback.
    Intervention: Other: Hemodialysis without biofeedback
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact: Jennifer MacRae, MD 403-944-8168 jennifer.macrae@albertahealthservices.ca
Canada
 
NCT01749761
H12-02619
No
Dr Jennifer MacRae, University of Calgary
University of Calgary
  • University of British Columbia
  • B. Braun Medical Inc.
Principal Investigator: Jennifer M MacRae, MD University of Calgary
University of Calgary
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP