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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
| B. Braun Medical Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysis without biofeedback | Placebo Comparator | Patients will be randomized to receive hemodialysis without biofeedback for a period of 8 weeks. |
|
| BioLogic RR biofeedback | Active Comparator | Patients will receive 8 weeks of HD with BioLogic RR Blood pressure guided biofeedback. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioLogic RR | Other | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| urea clearance | Change in urea clearance | 8 weeks |
| Brain natriuretic peptide | change in BNP | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation saturation | Reduction in the minimum 02 saturation achieved | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer M MacRae, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Paul's Hospital Hemodialysis Unit | Vancouver | British Columbia | V6Z1Y6 | Canada |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D026441 | Mind-Body Therapies |
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| Hemodialysis without biofeedback | Other | patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks |
|
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| 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 |
| D000529 |
| Complementary Therapies |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |