Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

NCT03578510 | Completed

• 1 other identifier: AVPII study
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With End Stage Renal Disease on Hemodialysis

Keywords

Hemodialysis, sodium, endothelium, sympathetic activity, vasopressin

Outcome Measures

Primary Outcomes (1)

• 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  Before, after 30, 60, 120 and 180 minutes and after dialysis blood is withdrawn from the dialysis line to determine plasma levels of vasopressin.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 Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (2)

SHD

ACTIVE COMPARATOR

Standard hemodialysis

Device: Hemocontrol hemodialysis; Device: Standard hemodialysis

HHD

EXPERIMENTAL

Hemocontrol hemodialysis

Device: Hemocontrol hemodialysis; Device: Standard hemodialysis

Interventions

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.

HHD; SHD

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.

HHD; SHD

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• A thrice-weekly 4 hours hemodialysis schedule
• Dialysis on an arteriovenous fistula
• A usual interdialytic weight gain of ≥2.0 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 30134847 DERIVED

MeSH Terms

Conditions

Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: July 6, 2018
• Study Start: September 17, 2012
• Primary Completion: March 25, 2013
• Study Completion: March 25, 2013
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

NL (1)