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

Hypotension Clinical Trial

— BP-RIDH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749761
• Other study ID #: H12-02619
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: June 14, 2014
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension

Intervention

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

Locations

Country	Name	City	State
Canada	St.Paul's Hospital Hemodialysis Unit	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	B. Braun Medical Inc., University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxygenation saturation	Reduction in the minimum 02 saturation achieved	8 weeks	No
Primary	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	No
Secondary	urea clearance	Change in urea clearance	8 weeks	No
Secondary	Brain natriuretic peptide	change in BNP	8 weeks	No
Secondary	intradialytic hypotension (blood pressure criteria alone)	Reduction in the number of IDH episodes based on BP criteria alone	8 weeks	No
Secondary	Intradialytic symptoms	Reduction in the number of intradialytic symptoms	8 weeks	No