Skip to main content
OpenTrials
Completed

NCT Number: NCT03578510

Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in plasma vasopressin levels

    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.

    Plasma levels of the antidiuretic hormone, i.e. vasopressin

Secondary outcomes

  1. Change in systolic and diastolic blood pressure in mmHg

    Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis

  2. Change in heart rate in beats per minute

    Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis

  3. Change in relative blood volume in %

    Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis

  4. Change in plasma sodium levels in mmol/L

    Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis

Other outcomes

  1. Change in plasma osmolality levels in milliosmol/kg

    Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis

  2. Change in nitrite and nitrate levels in µmol/L

    Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis

  3. Change in plasma noradrenalin levels in mmol/L

    Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis

  4. Change in heart rate variability in ms

    Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis

  5. Change in baroreflex sensitivity in ms/mmHg

    Time frame: Before, after 30, 60, 120 and 180 minutes and after dialysis

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 6, 2018
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.