Intradialytic HypotensionNCT01988181
Adjusting Fluid Removal Based on Blood Volume in Hemodialysis: A Randomized Study
A study testing BVM-UF biofeedback and Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany) in people with Intradialytic Hypotension and End Stage Renal Failure on Dialysis, run by University of Calgary at 1 site in Canada.
Trial summary
As kidney function declines, the ability to maintain water balance is impaired and is most often treated with hemodialysis. The removal of excess water in hemodialysis often leads to a sudden drop of blood pressure and causes symptoms of dizziness, light-headedness, cramping, and chest pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Hypotension, End Stage Renal Failure on Dialysis
- What is being tested?
- BVM-UF biofeedback and Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Serum sodium ≤133mmol/L
- Hemoglobin <80g/L
- Active Malignancy
- History of blood transfusions or hospitalizations in the preceding 4 weeks
- Planned change in the renal replacement modality during the planned study period
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Health Services Southern Alberta Renal Program
Calgary, Alberta, T2N 2T9
About this study
Official title: Blood Volume Monitoring Guided Ultrafiltration Biofeedback on Reduction of Intra-dialytic Hypotensive Episodes in Hemodialysis: A Randomized Cross Over Study
As kidney function declines, the ability to maintain water balance is impaired and is most often treated with hemodialysis. The removal of excess water in hemodialysis often leads to a sudden drop of blood pressure and causes symptoms of dizziness, light-headedness, cramping, and chest pain. This sudden drop in blood pressure has been linked with complications of heart attacks, strokes and even death. Research has focused on different ways to prevent dangerous drops in blood pressure during hemodialysis. One way is the use of blood volume monitoring biofeedback technology to monitor the patient's relative blood volume and automatically reduce the amount of fluid that is being removed when the blood volume is low to prevent the drop in blood pressure from occurring. This type of biofeedback device is currently available on some hemodialysis machines and while this approach appealing, it is not clear how effective this form of biofeedback is in preventing the drops in blood pressure.
We plan to determine if the use of biofeedback based on the changes in the patient's blood volume will reduce the number of sudden drops in blood pressure that occur during hemodialysis. To do this, we will compare patients treated with this technology to current hemodialysis practices and follow them for important adverse outcomes. The result of interest will be the frequency of hemodialysis sessions complicated by a sudden symptomatic drop in blood pressure. We also plan to monitor the amount of water in the different body compartments, blood pressure, blood pressure medication use, markers of heart function, and patient symptoms and quality of life.
We hope that by providing information on this technology we can reduce the sudden drops in blood pressure in hemodialysis, the associated rates of serious disease or death, and improve patient quality of life.
Read the detailed description
This is a 22 week parallel group, randomized crossover trial to determine the effect of blood volume monitoring, BVM, guided ultrafiltration (UF) biofeedback on symptomatic intradialytic hypotension (IDH) episodes amongst IDH prone patients. The first part of the study (Part 1 - Run-In/Dialysis Optimization Phase), eligible patients will undergo a four-week run-in phase. During this period all patients will undergo a comprehensive clinical assessment including, clinical weight assessment, anti-hypertensive medication review, and dialysis prescription standardization. At the end of the run-in phase, patients that still meet eligibility criteria will enter the randomized cross-over phase. In part 2 (Randomized Cross-Over Phase), patients are randomized to regular best clinical practice hemodialysis, HD (without BVM-guided UF biofeedback; control arm) or to BVM-guided UF biofeedback (intervention arm) for an 8 week period. This will be followed by a two-week washout phase and then patients will be crossed over for a second 8-week phase. The study will be conducted and reported following the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines.
- Being tested
- BVM-UF biofeedback, Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)
- Keywords
- Intradialytic Hypotension, Renal Dialysis, Blood Volume Determination, Clinical Trials, Randomized, Crossover Studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVM-UF biofeedbackDevice
Also called Fresenius 5008 HD machine with UF control
The Fresenius 5008 uses an ultrasound and temperature monitor incorporated into the machine to detect ultrasonic velocity and temperature changes to derive the total protein concentration, which is a sum of total plasma proteins and hemoglobin. The relative blood volume is calculated at by dividing the initial concentration of total protein by the total protein concentration at any given time, multiplied by 100. The HD software is based on the critical blood volume entered at the beginning of the dialysis session for each individual patient. The UF rate is adjusted based on the changes in the relative blood volume to the patient's critical relative blood volume.
Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)Device
For an 8-week period, patients in the best clinical practice (control) phase will use their same prescription as the run-in phase, dialysate sodium of 138mmol/L, dialysate calcium of 1.25mmol/L, dialysate temperature of 36oC, and constant UF rate. BVM will be disabled in this group.
| Study group | Role | What they receive |
|---|---|---|
| Best clinical practice HD | Active comparator | All study patients will be dialyzed with the Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany) using high flux dialyzers. For an 8-week period, patients in the best clinical practice (control) phase will use their same prescription as the run-in phase, dialysate sodium of 138mmol/L, dialysate calcium of 1.25mmol/L, dialysate temperature of 36oC, and constant UF rate. BVM will be disabled in this group. Receives: Device: Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany) |
| Best clinical practice plus BVM-guided UF biofeedback | Experimental | Patients in the BVM-guided UF biofeedback (intervention) phase will have the same prescription as the control group but will also have the ultrafiltration rate automatically adjusted by the Fresenius 5008 HD machine based on the changes in the relative blood volume. Receives: Device: BVM-UF biofeedback; Device: Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the rate of symptomatic IDH during hemodialysis
The primary outcome will be rate of symptomatic IDH as defined by an abrupt drop in the systolic blood pressure of ≥20mm Hg when compared to baseline along with an abrupt onset headache, dizziness, unconsciousness, thirst, dyspnea, angina, muscle cramps, or vomiting (reflecting cerebral, cardiac, gastrointestinal, or musculoskeletal ischemia). The end of an episode of IDH will be defined as resolution of the symptom. The number of symptomatic IDH episodes along with the duration of each dialysis treatment will be captured. The rate of IDH for each session will be calculated by dividing the number of episodes by the duration of the session in hours. The rate of IDH will be calculated for every dialysis treatment. The rate of symptomatic IDH will be measured in the two months preceding enrollment, during each phase of the study.
Measured: During hemodialysis up to the 22 week study period
Secondary outcomes (12)
Change in the number of symptomatic IDH per dialysis session
The number of symptomatic IDH episodes in each dialysis treatment will be captured. IDH is defined as in the primary outcome.
Measured: During hemodialysis up to the 22 week study period
Change in the frequency of symptomatic IDH
The number of symptomatic IDH episodes of each dialysis treatment will be captured. IDH is defined as in the primary outcome.
Measured: During hemodialysis up to the 22 week study period
Number and Frequency of Nursing Interventions during hemodialysis
IDH-related nursing interventions are defined as the use of Trendelenburg/supine position, discontinuation of UF, fluid/saline challenge, return of blood, shortened dialysis run, or prolonged (more than 15 minutes) post-dialysis recovery period as a result of IDH or its symptoms. Given the subjective nature of IDH-related symptoms and intervention, in-services and customized dialysis run sheets will be provided to all nurses at participating dialysis centers to ensure that all events are recorded and recorded consistently. The number of symptomatic IDH episodes per session will be record.
Measured: During hemodialysis up to the 22 week study period
Change in Single Session Dialysis Adequacy
Patients that experience symptomatic IDH may require a reduction in the duration of HD treatments with a resultant reduction in dialysis adequacy. Dialysis adequacy will be measured and recorded (usual care) at the end of each dialysis session on the session sheet as single-pooled Kt/V. Single-pooled Kt/v is measured using the previously validated online clearance measurement method, which detects changes in conductivity in the dialysate to reflect the clearance of serum electrolytes and urea.
Measured: After hemodialysis up to the 22 week study period
Electrical Bio-impedance for the determination of change in hydration and fluid status
Whole body and segmental bio-impedance analysis for the determination of fluid composition has been validated in HD patients. Improvement of dry weight has been linked with reduced mortality. Electrical bio-impedance will be performed at the end of the mid-week HD session at week 1, 4, 8, 12, 14, 18, and 22 to determine the total body water, extracellular fluid volume (ECFV), intracellular fluid volume (ICFV), and the ECFV:ICFV ratio.
Measured: At the end of the mid-week HD session at week 1, 4, 8, 12, 14, 18, and 22. Up to week 22 study period.
Change in Serum Brain Natriuretic Peptide (BNP)
Chronic hypervolemia in HD is associated with increase in left atrial volume and BNP, which has been shown to predict mortality. Serum BNP will be measured at the beginning of the mid-week HD session at week 1, 4, 12, 14, and 22.
Measured: At the beginning of the mid-week HD session at week 1, 4, 12, 14, and 22. Up to week 22 study period.
Change in Serum high sensitivity cardiac troponin (hs-Troponin)
Biomarkers of cardiac damage such as hs-Troponin are more elevated in HD patients with myocardial stunning and is associated with an increased all-cause mortality. Improved and more frequent dialysis has been associated with a decrease in myocardial stunning, and a trend towards decreasing hs-troponin. Serum hs-Troponin will be performed at the beginning of the mid-week HD session at week 1, 4, 12, 14, and 22.
Measured: At the beginning of the mid-week HD session at week 1, 4, 12, 14, and 22. Up to week 22 study period.
Change in antihypertensive medication use
Improvements in a patient's volume status and blood pressure allows for a decrease number or dose of anti-hypertensive medications. The class and number of anti-hypertensive medications will be obtained from the electronic clinical database and subsequently confirmed with a patient interview at enrollment and the mid-week HD session at week 4, 8, 12, 14, 18, and 22. The study investigator will perform medication reconciliation
Measured: At enrollment and the mid-week HD session at week 4, 8, 12, 14, 18, and 22.
Relative blood volume Curve
The shape and slope of the RBV curve has been associated with symptomatic hypotensive episodes in HD. The relative blood volume curve will be downloaded from the Fresenius 5008 dialysis machine to a study computer on a regular basis for all patients in the run-in phase and those in the intervention arm following randomization. The relative blood volume achieved, maximum slope (%/h) of the BVM curve as defined by the percent (%) decline over time (h) will be calculated. The subjective pattern of BVM curve (flat, linear, concave upward, concave downward, regular and irregular line will be determined by the study investigator.
Measured: After every hemodialysis session, up to the 22 week study period.
Improvement in Intra-dialytic symptom survey
Currently no validated intra-dialytic symptom survey exists to provide an objective measure of intra-dialytic symptom burden. The survey will inquire about the intra-dialytic symptoms of IDH, specifically nausea, vomiting, chest pain, shortness of breath, headache, muscle cramps, dizziness, fainting, fatigue, and anxiety. The survey will be provided by the dialysis nurse, and to be completed by the patient or in conjunction with the dialysis nurse at the end of the dialysis session during weeks 1, 4, 8, 12, 14, 18, and 22. The survey is expected to take less than 1 minute to complete.
Measured: At the end of each dialysis session, during weeks 1, 4, 8, 12, 14, 18, and 22. Up to the 22 week study period.
Improvement in Inter-dialytic symptom survey
A survey inquiring about inter-dialytic recovery time to baseline will be provided by the dialysis nurse, and to be completed by the patient or in conjunction with the dialysis nurse at the beginning of dialysis during weeks 1, 4, 8, 12, 14, 18, and 22. The survey will inquire the time it took the patient to recovery from the last dialysis session, is validated in HD patients as a robust assessment quality of life. The survey will take less than 30 seconds to complete.
Measured: At the beginning of each dialysis session, during weeks 1, 4, 8, 12, 14, 18, and 22. Up to the 22 week study period.
Assessment of Nursing Perception, Attitudes, and Satisfaction of BVM guided UF biofeedback system
A survey inquiring about nursing perception and attitudes of the BVM guided UF biofeedback will be provided to the nurses at the end of the control and intervention phase. The survey is developed for the purpose of this study.
Measured: At the end of the control and intervention phase (end of week 12 and 22). Up to the 22 week study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jennifer MacRae, University of Calgary
- Investigators
- Robert Quinn, MD PhD, Study director, University of CalgaryKelvin Leung, MD, Study director, University of CalgaryJennifer MacRae, MD MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988181
- Sponsor's protocol ID
- BVM-RXOS
- Status last verified
- Jul 2015
- First submitted
- 6 Nov 2013
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wizemann V, Wabel P, Chamney P, Zaluska W, Moissl U, Rode C, Malecka-Masalska T, Marcelli D. The mortality risk of overhydration in haemodialysis patients. Nephrol Dial Transplant. 2009 May;24(5):1574-9. doi: 10.1093/ndt/gfn707. Epub 2009 Jan 7.
PubMed 19131355Velasco N, Chamney P, Wabel P, Moissl U, Imtiaz T, Spalding E, McGregor M, Innes A, MacKay I, Patel R, Jardine A. Optimal fluid control can normalize cardiovascular risk markers and limit left ventricular hypertrophy in thrice weekly dialysis patients. Hemodial Int. 2012 Oct;16(4):465-72. doi: 10.1111/j.1542-4758.2012.00689.x. Epub 2012 Apr 20.
PubMed 22515643Shoji T, Tsubakihara Y, Fujii M, Imai E. Hemodialysis-associated hypotension as an independent risk factor for two-year mortality in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1212-20. doi: 10.1111/j.1523-1755.2004.00812.x.
PubMed 15327420Selby NM, McIntyre CW. The acute cardiac effects of dialysis. Semin Dial. 2007 May-Jun;20(3):220-8. doi: 10.1111/j.1525-139X.2007.00281.x.
PubMed 17555488Schreiber MJ Jr. Setting the stage. Am J Kidney Dis. 2001 Oct;38(4 Suppl 4):S1-S10. doi: 10.1053/ajkd.2001.28089.
PubMed 11602455Schneditz D, Pogglitsch H, Horina J, Binswanger U. A blood protein monitor for the continuous measurement of blood volume changes during hemodialysis. Kidney Int. 1990 Aug;38(2):342-6. doi: 10.1038/ki.1990.207. No abstract available.
PubMed 2205752Schmidt R, Roeher O, Hickstein H, Korth S. Prevention of haemodialysis-induced hypotension by biofeedback control of ultrafiltration and infusion. Nephrol Dial Transplant. 2001 Mar;16(3):595-603. doi: 10.1093/ndt/16.3.595.
PubMed 11239038Davenport A. Using dialysis machine technology to reduce intradialytic hypotension. Hemodial Int. 2011 Oct;15 Suppl 1:S37-42. doi: 10.1111/j.1542-4758.2011.00600.x.
PubMed 22093599Daugirdas JT. Dialysis hypotension: a hemodynamic analysis. Kidney Int. 1991 Feb;39(2):233-46. doi: 10.1038/ki.1991.28. No abstract available.
PubMed 2002637Dasselaar JJ, Huisman RM, DE Jong PE, Franssen CF. Relative blood volume measurements during hemodialysis: comparisons between three noninvasive devices. Hemodial Int. 2007 Oct;11(4):448-55. doi: 10.1111/j.1542-4758.2007.00216.x.
PubMed 17922743Agarwal R, Kelley K, Light RP. Diagnostic utility of blood volume monitoring in hemodialysis patients. Am J Kidney Dis. 2008 Feb;51(2):242-54. doi: 10.1053/j.ajkd.2007.10.036.
PubMed 18215702Agarwal R. Hypervolemia is associated with increased mortality among hemodialysis patients. Hypertension. 2010 Sep;56(3):512-7. doi: 10.1161/HYPERTENSIONAHA.110.154815. Epub 2010 Jul 12.
PubMed 20625076Leung KC, Quinn RR, Ravani P, MacRae JM. Ultrafiltration biofeedback guided by blood volume monitoring to reduce intradialytic hypotensive episodes in hemodialysis: study protocol for a randomized controlled trial. Trials. 2014 Dec 10;15:483. doi: 10.1186/1745-6215-15-483.
PubMed 25496294
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Volume Monitoring Guided Ultrafiltration Biofeedback on Reduction of Intra-dialytic Hypotensive Episodes in Hemodialysis: A Randomized Cross Over Study
- ClinicalTrials.gov ID
- NCT01988181
- Acronym / sponsor ID
- BVM-RXOS
- Keywords
- Intradialytic Hypotension, Renal Dialysis, Blood Volume Determination, Clinical Trials, Randomized, Crossover Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As kidney function declines, the ability to maintain water balance is impaired and is most often treated with hemodialysis. The removal of excess water in hemodialysis often leads to a sudden drop of blood pressure and causes symptoms of dizziness, light-headedness, cramping, and chest pain. This sudden drop in blood pressure has been linked with complications of heart attacks, strokes and even death. Research has focused on different ways to prevent dangerous drops in blood pressure during hemodialysis. One way is the use of blood volume monitoring biofeedback technology to monitor the patient's relative blood volume and automatically reduce the amount of fluid that is being removed when the blood volume is low to prevent the drop in blood pressure from occurring. This type of biofeedback device is currently available on some hemodialysis machines and while this approach appealing, it is not clear how effective this form of biofeedback is in preventing the drops in blood pressure.
We plan to determine if the use of biofeedback based on the changes in the patient's blood volume will reduce the number of sudden drops in blood pressure that occur during hemodialysis. To do this, we will compare patients treated with this technology to current hemodialysis practices and follow them for important adverse outcomes. The result of interest will be the frequency of hemodialysis sessions complicated by a sudden symptomatic drop in blood pressure. We also plan to monitor the amount of water in the different body compartments, blood pressure, blood pressure medication use, markers of heart function, and patient symptoms and quality of life.
We hope that by providing information on this technology we can reduce the sudden drops in blood pressure in hemodialysis, the associated rates of serious disease or death, and improve patient quality of life.
Detailed description
This is a 22 week parallel group, randomized crossover trial to determine the effect of blood volume monitoring, BVM, guided ultrafiltration (UF) biofeedback on symptomatic intradialytic hypotension (IDH) episodes amongst IDH prone patients. The first part of the study (Part 1 - Run-In/Dialysis Optimization Phase), eligible patients will undergo a four-week run-in phase. During this period all patients will undergo a comprehensive clinical assessment including, clinical weight assessment, anti-hypertensive medication review, and dialysis prescription standardization. At the end of the run-in phase, patients that still meet eligibility criteria will enter the randomized cross-over phase. In part 2 (Randomized Cross-Over Phase), patients are randomized to regular best clinical practice hemodialysis, HD (without BVM-guided UF biofeedback; control arm) or to BVM-guided UF biofeedback (intervention arm) for an 8 week period. This will be followed by a two-week washout phase and then patients will be crossed over for a second 8-week phase. The study will be conducted and reported following the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best clinical practice HD | Active comparator | Device: Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)All study patients will be dialyzed with the Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany) using high flux dialyzers. For an 8-week period, patients in the best clinical practice (control) phase will use their same prescription as the run-in phase, dialysate sodium of 138mmol/L, dialysate calcium of 1.25mmol/L, dialysate temperature of 36oC, and constant UF rate. BVM will be disabled in this group. |
| Best clinical practice plus BVM-guided UF biofeedback | Experimental | Device: BVM-UF biofeedback, Device: Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)Patients in the BVM-guided UF biofeedback (intervention) phase will have the same prescription as the control group but will also have the ultrafiltration rate automatically adjusted by the Fresenius 5008 HD machine based on the changes in the relative blood volume. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Serum sodium ≤133mmol/L
- Hemoglobin <80g/L
- Active Malignancy
- History of blood transfusions or hospitalizations in the preceding 4 weeks
- Planned change in the renal replacement modality during the planned study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BVM-UF biofeedbackAlso: Fresenius 5008 HD machine with UF controlThe Fresenius 5008 uses an ultrasound and temperature monitor incorporated into the machine to detect ultrasonic velocity and temperature changes to derive the total protein concentration, which is a sum of total plasma proteins and hemoglobin. The relative blood volume is calculated at by dividing the initial concentration of total protein by the total protein concentration at any given time, multiplied by 100. The HD software is based on the critical blood volume entered at the beginning of the dialysis session for each individual patient. The UF rate is adjusted based on the changes in the relative blood volume to the patient's critical relative blood volume. | Device | Best clinical practice plus BVM-guided UF biofeedback |
| Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)For an 8-week period, patients in the best clinical practice (control) phase will use their same prescription as the run-in phase, dialysate sodium of 138mmol/L, dialysate calcium of 1.25mmol/L, dialysate temperature of 36oC, and constant UF rate. BVM will be disabled in this group. | Device | Best clinical practice HD, Best clinical practice plus BVM-guided UF biofeedback |
Primary outcome
Change in the rate of symptomatic IDH during hemodialysis
Time frame: During hemodialysis up to the 22 week study period
The primary outcome will be rate of symptomatic IDH as defined by an abrupt drop in the systolic blood pressure of ≥20mm Hg when compared to baseline along with an abrupt onset headache, dizziness, unconsciousness, thirst, dyspnea, angina, muscle cramps, or vomiting (reflecting cerebral, cardiac, gastrointestinal, or musculoskeletal ischemia). The end of an episode of IDH will be defined as resolution of the symptom. The number of symptomatic IDH episodes along with the duration of each dialysis treatment will be captured. The rate of IDH for each session will be calculated by dividing the number of episodes by the duration of the session in hours. The rate of IDH will be calculated for every dialysis treatment. The rate of symptomatic IDH will be measured in the two months preceding enrollment, during each phase of the study.
12 secondary outcomes
Change in the number of symptomatic IDH per dialysis session
Time frame: During hemodialysis up to the 22 week study period
Change in the frequency of symptomatic IDH
Time frame: During hemodialysis up to the 22 week study period
Number and Frequency of Nursing Interventions during hemodialysis
Time frame: During hemodialysis up to the 22 week study period
Change in Single Session Dialysis Adequacy
Time frame: After hemodialysis up to the 22 week study period
Electrical Bio-impedance for the determination of change in hydration and fluid status
Time frame: At the end of the mid-week HD session at week 1, 4, 8, 12, 14, 18, and 22. Up to week 22 study period.
Change in Serum Brain Natriuretic Peptide (BNP)
Time frame: At the beginning of the mid-week HD session at week 1, 4, 12, 14, and 22. Up to week 22 study period.
Change in Serum high sensitivity cardiac troponin (hs-Troponin)
Time frame: At the beginning of the mid-week HD session at week 1, 4, 12, 14, and 22. Up to week 22 study period.
Change in antihypertensive medication use
Time frame: At enrollment and the mid-week HD session at week 4, 8, 12, 14, 18, and 22.
Relative blood volume Curve
Time frame: After every hemodialysis session, up to the 22 week study period.
Improvement in Intra-dialytic symptom survey
Time frame: At the end of each dialysis session, during weeks 1, 4, 8, 12, 14, 18, and 22. Up to the 22 week study period.
Improvement in Inter-dialytic symptom survey
Time frame: At the beginning of each dialysis session, during weeks 1, 4, 8, 12, 14, 18, and 22. Up to the 22 week study period.
Assessment of Nursing Perception, Attitudes, and Satisfaction of BVM guided UF biofeedback system
Time frame: At the end of the control and intervention phase (end of week 12 and 22). Up to the 22 week study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- Background: PubMed 19131355Wizemann V, Wabel P, Chamney P, Zaluska W, Moissl U, Rode C, Malecka-Masalska T, Marcelli D. The mortality risk of overhydration in haemodialysis patients. Nephrol Dial Transplant. 2009 May;24(5):1574-9. doi: 10.1093/ndt/gfn707. Epub 2009 Jan 7.
- Background: PubMed 22515643Velasco N, Chamney P, Wabel P, Moissl U, Imtiaz T, Spalding E, McGregor M, Innes A, MacKay I, Patel R, Jardine A. Optimal fluid control can normalize cardiovascular risk markers and limit left ventricular hypertrophy in thrice weekly dialysis patients. Hemodial Int. 2012 Oct;16(4):465-72. doi: 10.1111/j.1542-4758.2012.00689.x. Epub 2012 Apr 20.
- Background: PubMed 15327420Shoji T, Tsubakihara Y, Fujii M, Imai E. Hemodialysis-associated hypotension as an independent risk factor for two-year mortality in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1212-20. doi: 10.1111/j.1523-1755.2004.00812.x.
- Background: PubMed 17555488Selby NM, McIntyre CW. The acute cardiac effects of dialysis. Semin Dial. 2007 May-Jun;20(3):220-8. doi: 10.1111/j.1525-139X.2007.00281.x.
- Background: PubMed 11602455Schreiber MJ Jr. Setting the stage. Am J Kidney Dis. 2001 Oct;38(4 Suppl 4):S1-S10. doi: 10.1053/ajkd.2001.28089.
- Background: PubMed 2205752Schneditz D, Pogglitsch H, Horina J, Binswanger U. A blood protein monitor for the continuous measurement of blood volume changes during hemodialysis. Kidney Int. 1990 Aug;38(2):342-6. doi: 10.1038/ki.1990.207. No abstract available.
- Background: PubMed 11239038Schmidt R, Roeher O, Hickstein H, Korth S. Prevention of haemodialysis-induced hypotension by biofeedback control of ultrafiltration and infusion. Nephrol Dial Transplant. 2001 Mar;16(3):595-603. doi: 10.1093/ndt/16.3.595.
- Background: PubMed 22093599Davenport A. Using dialysis machine technology to reduce intradialytic hypotension. Hemodial Int. 2011 Oct;15 Suppl 1:S37-42. doi: 10.1111/j.1542-4758.2011.00600.x.
- Background: PubMed 2002637Daugirdas JT. Dialysis hypotension: a hemodynamic analysis. Kidney Int. 1991 Feb;39(2):233-46. doi: 10.1038/ki.1991.28. No abstract available.
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- Background: PubMed 18215702Agarwal R, Kelley K, Light RP. Diagnostic utility of blood volume monitoring in hemodialysis patients. Am J Kidney Dis. 2008 Feb;51(2):242-54. doi: 10.1053/j.ajkd.2007.10.036.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Quinn, MD PhD study director
University of Calgary
Kelvin Leung, MD study director
University of Calgary
Jennifer MacRae, MD MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BVM-UF biofeedback and Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany) in people with Intradialytic Hypotension and End Stage Renal Failure on Dialysis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the rate of symptomatic IDH during hemodialysis (time frame: During hemodialysis up to the 22 week study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988181, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.