Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotension (BP-RIDH)
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|ClinicalTrials.gov Identifier: NCT01749761|
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : June 17, 2014
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 or disease||Intervention/treatment||Phase|
|Hypotension||Other: BioLogic RR Other: Hemodialysis without biofeedback||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Blood Pressure Guided Biofeedback on Hemodialysis and the Reduction of IntraDialytic Hypotensive Episodes: A Randomized Cross Over Trial|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||December 2013|
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
- intradialytic hypotension episodes [ Time Frame: By the end of the 8 week intervention period ]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
- urea clearance [ Time Frame: 8 weeks ]Change in urea clearance
- Brain natriuretic peptide [ Time Frame: 8 weeks ]change in BNP
- intradialytic hypotension (blood pressure criteria alone) [ Time Frame: 8 weeks ]Reduction in the number of IDH episodes based on BP criteria alone
- Intradialytic symptoms [ Time Frame: 8 weeks ]Reduction in the number of intradialytic symptoms
- Oxygenation saturation [ Time Frame: 8 weeks ]Reduction in the minimum 02 saturation achieved
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749761
|Canada, British Columbia|
|St.Paul's Hospital Hemodialysis Unit|
|Vancouver, British Columbia, Canada, V6Z1Y6|
|Principal Investigator:||Jennifer M MacRae, MD||University of Calgary|