An interventional study of Hemocontrol hemodialysis and Standard hemodialysis in Patients With End Stage Renal Disease on Hemodialysis, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Basic science
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 29 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard hemodialysis
Device: Hemocontrol hemodialysis · Device: Standard hemodialysis
Hemocontrol hemodialysis
Device: Hemocontrol hemodialysis · Device: Standard 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.
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.
Change in plasma vasopressin levels
Plasma levels of the antidiuretic hormone, i.e. vasopressin
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis blood is withdrawn from the dialysis line to determine plasma levels of vasopressin.
Change in systolic and diastolic blood pressure in mmHg
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in heart rate in beats per minute
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in relative blood volume in %
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in plasma sodium levels in mmol/L
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in plasma osmolality levels in milliosmol/kg
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in nitrite and nitrate levels in µmol/L
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in plasma noradrenalin levels in mmol/L
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in heart rate variability in ms
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Change in baroreflex sensitivity in ms/mmHg
Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Plan to share: Undecided
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Medical Center Groningen