Adjusting Fluid Removal Based on Blood Volume in Hemodialysis: A Randomized Study

NCT01988181 | Completed

• 1 other identifier: BVM-RXOS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intradialytic Hypotension; End Stage Renal Failure on Dialysis

Keywords

Intradialytic Hypotension; Renal Dialysis; Blood Volume Determination; Clinical Trials, Randomized; Crossover Studies

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Change in the number of symptomatic IDH per dialysis session

  During hemodialysis up to the 22 week study period

• Change in the frequency of symptomatic IDH

  During hemodialysis up to the 22 week study period

• Number and Frequency of Nursing Interventions during hemodialysis

  During hemodialysis up to the 22 week study period

• Change in Single Session Dialysis Adequacy

  After hemodialysis up to the 22 week study period

• Electrical Bio-impedance for the determination of change in hydration and fluid status

  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.

Study Arms (2)

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.

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.

Device: BVM-UF biofeedback; Device: Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)

Interventions

BVM-UF biofeedback DEVICE

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.

Also known as: Fresenius 5008 HD machine with UF control

Best clinical practice plus BVM-guided UF biofeedback

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.

Best clinical practice HD; Best clinical practice plus BVM-guided UF biofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.
• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Health Services Southern Alberta Renal Program

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (13)

• 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.

  PMID: 19131355 BACKGROUND

• 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.

  PMID: 22515643 BACKGROUND

• 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. doi: 10.1111/j.1523-1755.2004.00812.x.

  PMID: 15327420 BACKGROUND

• Selby 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.

  PMID: 17555488 BACKGROUND

• Schreiber MJ Jr. Setting the stage. Am J Kidney Dis. 2001 Oct;38(4 Suppl 4):S1-S10. doi: 10.1053/ajkd.2001.28089.

  PMID: 11602455 BACKGROUND

• 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. doi: 10.1038/ki.1990.207. No abstract available.

  PMID: 2205752 BACKGROUND

• 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. doi: 10.1093/ndt/16.3.595.

  PMID: 11239038 BACKGROUND

• 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.

  PMID: 22093599 BACKGROUND

• Daugirdas JT. Dialysis hypotension: a hemodynamic analysis. Kidney Int. 1991 Feb;39(2):233-46. doi: 10.1038/ki.1991.28. No abstract available.

  PMID: 2002637 BACKGROUND

• 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. doi: 10.1111/j.1542-4758.2007.00216.x.

  PMID: 17922743 BACKGROUND

• 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.

  PMID: 18215702 BACKGROUND

• 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.

  PMID: 20625076 BACKGROUND

• Leung 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.

  PMID: 25496294 DERIVED

Study Officials

• Robert Quinn, MD PhD

  University of Calgary

  STUDY DIRECTOR

• Kelvin Leung, MD

  University of Calgary

  STUDY DIRECTOR

• Jennifer MacRae, MD MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Medicine

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 20, 2013
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

CA (1)