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

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.

Study Overview

• Status: Completed
• Conditions: Hypotension
• Intervention / Treatment: Other: BioLogic RR; Other: Hemodialysis without biofeedback

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • St.Paul's Hospital Hemodialysis Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
urea clearance	Change in urea clearance	8 weeks
Brain natriuretic peptide	change in BNP	8 weeks
intradialytic hypotension (blood pressure criteria alone)	Reduction in the number of IDH episodes based on BP criteria alone	8 weeks
Intradialytic symptoms	Reduction in the number of intradialytic symptoms	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation saturation	Reduction in the minimum 02 saturation achieved	8 weeks

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: University of British Columbia; B. Braun Medical Inc.
• Investigators: Principal Investigator: Jennifer M MacRae, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): June 17, 2014
• Last Update Submitted That Met QC Criteria: June 14, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: hemodialysis,; IDH, intradialytic hypotension,; hypotension on hemodialysis,; Blood pressure guided biofeedback
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: H12-02619