Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

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

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.

Study Overview

• Status: Completed
• Conditions: Patients With End Stage Renal Disease on Hemodialysis
• Intervention / Treatment: Device: Hemocontrol hemodialysis; Device: Standard hemodialysis

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SHD; Standard hemodialysis	Device: Hemocontrol 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.; Device: Standard 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.
Experimental: HHD; Hemocontrol hemodialysis	Device: Hemocontrol 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.; Device: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Jan Kornelis de Cock Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2012
• Primary Completion (Actual): March 25, 2013
• Study Completion (Actual): March 25, 2013

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: June 23, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Hemodialysis, sodium, endothelium, sympathetic activity, vasopressin
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: AVPII study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No