Clinical trial NCT03578510: Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis
Official title: Is the Lower Incidence of Intradialytic Hypotension During Hemocontrol Dialysis in Comparison With Standard Hemodialysis Attributable to Enhanced to Higher Plasma Vasopressin Levels or to Enhanced Sympathetic Activity and/or to Less Nitric Oxide Production
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With End Stage Renal Disease on Hemodialysis
Keywords: Hemodialysis, sodium, endothelium, sympathetic activity, vasopressin
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in plasma vasopressin levels
timeFrame: Before, after 30, 60, 120 and 180 minutes and after dialysis blood is withdrawn from the dialysis line to determine plasma levels of vasopressin.
Secondary outcomes:
measure: Change in systolic and diastolic blood pressure in mmHg
timeFrame: Before, after 30, 60, 120 and 180 minutes and after dialysis
measure: Change in heart rate in beats per minute
timeFrame: Before, after 30, 60, 120 and 180 minutes and after dialysis
measure: Change in relative blood volume in %
timeFrame: Before, after 30, 60, 120 and 180 minutes and after dialysis
measure: Change in plasma sodium levels in mmol/L
timeFrame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Other outcomes:
measure: Change in plasma osmolality levels in milliosmol/kg
timeFrame: Before, after 30, 60, 120 and 180 minutes and after dialysis
measure: Change in nitrite and nitrate levels in µmol/L
timeFrame: Before, after 30, 60, 120 and 180 minutes and after dialysis
measure: Change in plasma noradrenalin levels in mmol/L
timeFrame: Before, after 30, 60, 120 and 180 minutes and after dialysis
measure: Change in heart rate variability in ms
timeFrame: Before, after 30, 60, 120 and 180 minutes and after dialysis
measure: Change in baroreflex sensitivity in ms/mmHg
timeFrame: Before, after 30, 60, 120 and 180 minutes and after dialysis
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
citation: 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.