Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Patients With End Stage Renal Disease on Hemodialysis

Treatments: Device: Hemocontrol hemodialysis; Device: Standard hemodialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03578510

AVPII study

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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29 participants in 2 patient groups

SHD

Active Comparator group

Description:

Standard hemodialysis

Treatment:

Device: Standard hemodialysis

Device: Hemocontrol hemodialysis

HHD

Experimental group

Description:

Hemocontrol hemodialysis

Treatment:

Device: Standard hemodialysis

Device: Hemocontrol hemodialysis