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Blood Volume Monitoring Guided Ultrafiltration Biofeedback on Reduction of Intra-dialytic Hypotensive Episodes in Hemodialysis: A Randomized Cross Over Study
In Brief
A clinical study evaluating BVM-UF biofeedback and Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany) for Intradialytic Hypotension and End Stage Renal Failure on Dialysis. Completed, enrolled 34 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.