Hypotension
Conditions
Keywords
IDH, intradialytic hypotension,, hypotension on hemodialysis,, hemodialysis,, Blood pressure guided biofeedback
Brief 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.
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.
Interventions
OTHERBioLogic 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
OTHERHemodialysis without biofeedback
patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks
Sponsors
University of British Columbia
B. Braun Medical Inc.
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intradialytic hypotension episodes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| urea clearance | 8 weeks | Change in urea clearance |
| Brain natriuretic peptide | 8 weeks | change in BNP |
| intradialytic hypotension (blood pressure criteria alone) | 8 weeks | Reduction in the number of IDH episodes based on BP criteria alone |
| Intradialytic symptoms | 8 weeks | Reduction in the number of intradialytic symptoms |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation saturation | 8 weeks | Reduction in the minimum 02 saturation achieved |
Countries
Canada
Outcome results
None listed