Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

Not Applicable

Completed

• Conditions: Patients With End Stage Renal Disease on Hemodialysis
• Interventions: Device: Hemocontrol hemodialysis; Device: Standard hemodialysis

• Registration Number: NCT03578510
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09-17
• Primary Completion: 2013-03-25
• Study Completion: 2013-03-25
• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-23
• Study First Posted: 2018-07-06
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HHD	Hemocontrol hemodialysis	Hemocontrol hemodialysis
SHD	Hemocontrol hemodialysis	Standard hemodialysis
SHD	Standard hemodialysis	Standard hemodialysis
HHD	Standard hemodialysis	Hemocontrol hemodialysis

Primary Outcome Measures

Name	Time	Method
Change in plasma vasopressin levels	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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands