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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHD | Active Comparator | Standard hemodialysis |
|
| HHD | Experimental | Hemocontrol hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemocontrol hemodialysis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma vasopressin levels | Plasma levels of the antidiuretic hormone, i.e. vasopressin | Before, after 30, 60, 120 and 180 minutes and after dialysis blood is withdrawn from the dialysis line to determine plasma levels of vasopressin. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic and diastolic blood pressure in mmHg | Before, after 30, 60, 120 and 180 minutes and after dialysis | |
| Change in heart rate in beats per minute | Before, after 30, 60, 120 and 180 minutes and after dialysis |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9700 RB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30134847 | Derived | Ettema EM, Kuipers J, van Faassen M, Groen H, van Roon AM, Lefrandt JD, Westerhuis R, Kema IP, van Goor H, Gansevoort RT, Gaillard CAJM, Franssen CFM. Effect of plasma sodium concentration on blood pressure regulators during hemodialysis: a randomized crossover study. BMC Nephrol. 2018 Aug 22;19(1):214. doi: 10.1186/s12882-018-0997-z. |
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| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Standard hemodialysis | Device | 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 relative blood volume in % | 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 |
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |