Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

Patients With End Stage Renal Disease on Hemodialysis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578510
• Other study ID #: AVPII study
• Status: Completed
• Phase: N/A
• Start date: September 17, 2012
• Est. completion date: March 25, 2013

Study information

• Verified date: May 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 25, 2013
• Est. primary completion date: March 25, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Patients With End Stage Renal Disease on Hemodialysis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in plasma osmolality levels in milliosmol/kg		Before, after 30, 60, 120 and 180 minutes and after dialysis
Other	Change in nitrite and nitrate levels in µmol/L		Before, after 30, 60, 120 and 180 minutes and after dialysis
Other	Change in plasma noradrenalin levels in mmol/L		Before, after 30, 60, 120 and 180 minutes and after dialysis
Other	Change in heart rate variability in ms		Before, after 30, 60, 120 and 180 minutes and after dialysis
Other	Change in baroreflex sensitivity in ms/mmHg		Before, after 30, 60, 120 and 180 minutes and after dialysis
Primary	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	Change in systolic and diastolic blood pressure in mmHg		Before, after 30, 60, 120 and 180 minutes and after dialysis
Secondary	Change in heart rate in beats per minute		Before, after 30, 60, 120 and 180 minutes and after dialysis
Secondary	Change in relative blood volume in %		Before, after 30, 60, 120 and 180 minutes and after dialysis
Secondary	Change in plasma sodium levels in mmol/L		Before, after 30, 60, 120 and 180 minutes and after dialysis