End Stage Renal Failure on Dialysis Clinical Trial
Official title:
Blood Volume Monitoring Guided Ultrafiltration Biofeedback on Reduction of Intra-dialytic Hypotensive Episodes in Hemodialysis: A Randomized Cross Over Study
Verified date | July 2015 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Run-in Phase Inclusion Criteria: - >18 years old - Maintenance hemodialysis patients for more than 3 months - Undergo hemodialysis 3-4 times per week for a minimum of three hours per session - Have >30% of their hemodialysis sessions in the preceding 8 weeks complicated by symptomatic IDH. - Able to provide written informed consent. Randomization Phase Inclusion Criteria: - >18 years old - Maintenance hemodialysis patients for more than 3 months - Undergo hemodialysis 3-4 times per week for a minimum of three hours per session - Have >30% of their hemodialysis sessions in the preceding 4 weeks complicated by symptomatic IDH. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Health Services Southern Alberta Renal Program | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Agarwal 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. — View Citation
Agarwal 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. — View Citation
Dasselaar 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. — View Citation
Daugirdas JT. Dialysis hypotension: a hemodynamic analysis. Kidney Int. 1991 Feb;39(2):233-46. — View Citation
Davenport 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. Review. — View Citation
Schmidt 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. — View Citation
Schneditz 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. — View Citation
Schreiber MJ Jr. Setting the stage. Am J Kidney Dis. 2001 Oct;38(4 Suppl 4):S1-S10. — View Citation
Selby NM, McIntyre CW. The acute cardiac effects of dialysis. Semin Dial. 2007 May-Jun;20(3):220-8. Review. — View Citation
Shoji 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. — View Citation
Velasco 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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | During hemodialysis up to the 22 week study period | No |
Secondary | 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. | During hemodialysis up to the 22 week study period | No |
Secondary | 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. | During hemodialysis up to the 22 week study period | No |
Secondary | 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. | During hemodialysis up to the 22 week study period | No |
Secondary | 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. | After hemodialysis up to the 22 week study period | No |
Secondary | 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. | 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. | No |
Secondary | 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. | At the beginning of the mid-week HD session at week 1, 4, 12, 14, and 22. Up to week 22 study period. | No |
Secondary | 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. | At the beginning of the mid-week HD session at week 1, 4, 12, 14, and 22. Up to week 22 study period. | No |
Secondary | 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 | At enrollment and the mid-week HD session at week 4, 8, 12, 14, 18, and 22. | No |
Secondary | 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. | After every hemodialysis session, up to the 22 week study period. | No |
Secondary | 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. | At the end of each dialysis session, during weeks 1, 4, 8, 12, 14, 18, and 22. Up to the 22 week study period. | No |
Secondary | 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. | At the beginning of each dialysis session, during weeks 1, 4, 8, 12, 14, 18, and 22. Up to the 22 week study period. | No |
Secondary | 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. | At the end of the control and intervention phase (end of week 12 and 22). Up to the 22 week study period. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04103177 -
Physical Activity in Haemodialysis Patients: a Feasibility Study
|
N/A | |
Completed |
NCT01561118 -
DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis
|
N/A | |
Withdrawn |
NCT03645720 -
The Prognosis of Graft Using Plastic Cannula in Hemodialysis
|
N/A | |
Active, not recruiting |
NCT02598635 -
Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis
|
Phase 4 | |
Terminated |
NCT01643733 -
Study on Fistuloplasty Using Flow Measurement Guidance
|
N/A | |
Not yet recruiting |
NCT03169400 -
Theranova Dialyzer and Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)
|
N/A | |
Completed |
NCT02439697 -
A Cohort Study of Conversion From Aranesp® to NESP® for the Treatment of Anemia in Dialysis Patients
|
N/A | |
Completed |
NCT02063490 -
Nurse-led Intervention to Improve Phosphate Binder Adherence
|
N/A | |
Completed |
NCT04106310 -
Theranova vs High-flux HD Comparison
|
N/A | |
Recruiting |
NCT06056102 -
CAR-T Cell Therapy for Desensitization in Kidney Transplantation
|
Phase 1 | |
Completed |
NCT04698512 -
MAgicTouchâ„¢ Intervention Leap for Dialysis Access (MATILDA) Trial
|
||
Completed |
NCT02819011 -
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
|
Phase 2 | |
Completed |
NCT02484118 -
Hemodialysis Blood Flow and Urea Clearance
|
N/A | |
Enrolling by invitation |
NCT01641757 -
Effect of Non-Surgical Periodontal Therapy on Serum Albumin Levels of Patients on Maintenance Hemodialysis Therapy,
|
Phase 2 | |
Completed |
NCT03172039 -
Antimicrobial Use and Stewardship in an Outpatient Hemodialysis Unit
|
N/A | |
Completed |
NCT03897231 -
Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis
|
||
Withdrawn |
NCT03145662 -
High Pressure Balloon vs Cutting Balloon
|
N/A | |
Completed |
NCT02621918 -
The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis
|
N/A | |
Completed |
NCT01356615 -
Low Molecular Weight Heparin for Hemodialysis Anticoagulation
|
N/A | |
Terminated |
NCT01033357 -
Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
|
N/A |