Patients With End Stage Renal Disease on Hemodialysis
Conditions
Keywords
Hemodialysis, sodium, endothelium, sympathetic activity, vasopressin
Brief summary
Intradialytic hypotension (IDH) is a frequent and serious complication that may occur during hemodialysis treatment. The investigators and others have shown that the Hemocontrol biofeedback system is associated with improved hemodynamic stability. Hemocontrol is a technique that guides the patients' blood volume along a pre-set trajectory by continuously adjusting the ultrafiltration rate and dialysate conductivity. In a recent pilotstudy, the investigators found significantly higher plasma vasopressin levels during the first hour of dialysis with Hemocontrol in comparison with standard hemodialysis. Increased vasopressin levels may contribute to intradialytic hemodynamic stability during hemodialysis by enhanced vasoconstriction. These results, however, did not prove directly that the improved hemodynamic stability with Hemocontrol is indeed caused by higher initial plasma vasopressin levels. Alternative explanations might be that 1) the higher initial plasma sodium levels with Hemocontrol dialysis enhance activity of the sympathetic nervous system directly, causing vasoconstriction and thereby improved hemodynamic stability and/or 2) that the higher initial plasma levels of sodium in Hemocontrol inhibit the release of nitric oxide by the vascular endothelium. Another goal of this study is to investigate whether vasopressin is removed with hemodialysis.
Interventions
DEVICEHemocontrol hemodialysis
Each participating patient underwent one standard hemodialysis and one hemodialysis with Hemocontrol in random order, both 4 hours in total duration. The Hemocontrol system guides the patients' blood volume along a predefined ideal relative blood volume trajectory, by continuously adjusting ultrafiltration volume and dialysate sodium concentration.
DEVICEStandard hemodialysis
Each participating patient underwent one standard hemodialysis and one hemodialysis with Hemocontrol in random order, both 4 hours in total duration. During standard hemodialysis, a constant ultrafiltration rate and dialysate conductivity was used.
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * A thrice-weekly 4 hours hemodialysis schedule * Dialysis on an arteriovenous fistula * A usual interdialytic weight gain of ≥2.0 kg
Exclusion criteria
* Age\<18 years * Dialysis duration of \<4 or \>4 hours * Dialysis frequency of \<3 or \>3 times a week * Dialysis on a central venous catheter * A usual interdialytic weight gain \<2 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma vasopressin levels | Before, after 30, 60, 120 and 180 minutes and after dialysis blood is withdrawn from the dialysis line to determine plasma levels of vasopressin. | Plasma levels of the antidiuretic hormone, i.e. vasopressin |
Secondary
| Measure | Time frame |
|---|---|
| Change in heart rate in beats per minute | Before, after 30, 60, 120 and 180 minutes and after dialysis |
| Change in relative blood volume in % | Before, after 30, 60, 120 and 180 minutes and after dialysis |
| Change in systolic and diastolic blood pressure in mmHg | Before, after 30, 60, 120 and 180 minutes and after dialysis |
| Change in plasma sodium levels in mmol/L | Before, after 30, 60, 120 and 180 minutes and after dialysis |
Other
| Measure | Time frame |
|---|---|
| Change in plasma osmolality levels in milliosmol/kg | Before, after 30, 60, 120 and 180 minutes and after dialysis |
| Change in nitrite and nitrate levels in µmol/L | Before, after 30, 60, 120 and 180 minutes and after dialysis |
| Change in plasma noradrenalin levels in mmol/L | Before, after 30, 60, 120 and 180 minutes and after dialysis |
| Change in heart rate variability in ms | Before, after 30, 60, 120 and 180 minutes and after dialysis |
| Change in baroreflex sensitivity in ms/mmHg | Before, after 30, 60, 120 and 180 minutes and after dialysis |
Countries
Netherlands
Outcome results
None listed