Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 25, 2013

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: SHD
    • Standard hemodialysis
  • Experimental: HHD
    • Hemocontrol hemodialysis

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medical Center Groningen
  • Collaborator
    • Jan Kornelis de Cock Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: dr. C.F.M. Franssen, Principal Investigator – University Medical Center Groningen

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.