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

NCT ID: NCT01988181

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-06-30

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.

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.

Conditions

Intradialytic Hypotension; End Stage Renal Failure on Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Best clinical practice HD

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.

Group Type: ACTIVE_COMPARATOR

Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)

Intervention Type: 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 plus BVM-guided UF biofeedback

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.

Group Type: EXPERIMENTAL

BVM-UF biofeedback

Intervention Type: 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.

Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)

Intervention Type: 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.

Interventions

BVM-UF biofeedback

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Fresenius 5008 HD machine with UF control

Eligibility Criteria

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.

• >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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr Jennifer MacRae

Associate Professor Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Quinn, MD PhD

Role: STUDY_DIRECTOR

University of Calgary

Kelvin Leung, MD

Role: STUDY_DIRECTOR

University of Calgary

Jennifer MacRae, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Alberta Health Services Southern Alberta Renal Program

Calgary, Alberta, Canada

Countries

Canada

References

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Other Identifiers

BVM-RXOS

Identifier Type: -

Identifier Source: org_study_id