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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypotension

Intervention / Treatment
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* Other: BioLogic RR
* Other: Hemodialysis without biofeedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Hemodialysis without biofeedback<br>Patients will be randomized to receive hemodialysis without biofeedback for a period of 8 weeks. | Other: BioLogic RR<br>* 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<br>* Other names: BioLogics Comfort RR, B Braun software;|
| Active Comparator: BioLogic RR biofeedback<br>Patients will receive 8 weeks of HD with BioLogic RR Blood pressure guided biofeedback. | Other: Hemodialysis without biofeedback<br>* patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks<br>* Other names: Hemodialysis;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IDH, intradialytic hypotension,, hypotension on hemodialysis,, hemodialysis,, Blood pressure guided biofeedback