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Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

Primary Purpose

Patients With End Stage Renal Disease on Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Hemocontrol hemodialysis
Standard hemodialysis
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Patients With End Stage Renal Disease on Hemodialysis focused on measuring Hemodialysis, sodium, endothelium, sympathetic activity, vasopressin

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SHD

HHD

Arm Description

Standard hemodialysis

Hemocontrol hemodialysis

Outcomes

Primary Outcome Measures

Change in plasma vasopressin levels
Plasma levels of the antidiuretic hormone, i.e. vasopressin

Secondary Outcome Measures

Change in systolic and diastolic blood pressure in mmHg
Change in heart rate in beats per minute
Change in relative blood volume in %
Change in plasma sodium levels in mmol/L

Full Information

First Posted
June 12, 2018
Last Updated
May 10, 2023
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT03578510
Brief Title
Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2012 (Actual)
Primary Completion Date
March 25, 2013 (Actual)
Study Completion Date
March 25, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With End Stage Renal Disease on Hemodialysis
Keywords
Hemodialysis, sodium, endothelium, sympathetic activity, vasopressin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHD
Arm Type
Active Comparator
Arm Description
Standard hemodialysis
Arm Title
HHD
Arm Type
Experimental
Arm Description
Hemocontrol hemodialysis
Intervention Type
Device
Intervention Name(s)
Hemocontrol hemodialysis
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard hemodialysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in plasma vasopressin levels
Description
Plasma levels of the antidiuretic hormone, i.e. vasopressin
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.
Secondary Outcome Measure Information:
Title
Change in systolic and diastolic blood pressure in mmHg
Time Frame
Before, after 30, 60, 120 and 180 minutes and after dialysis
Title
Change in heart rate in beats per minute
Time Frame
Before, after 30, 60, 120 and 180 minutes and after dialysis
Title
Change in relative blood volume in %
Time Frame
Before, after 30, 60, 120 and 180 minutes and after dialysis
Title
Change in plasma sodium levels in mmol/L
Time Frame
Before, after 30, 60, 120 and 180 minutes and after dialysis
Other Pre-specified Outcome Measures:
Title
Change in plasma osmolality levels in milliosmol/kg
Time Frame
Before, after 30, 60, 120 and 180 minutes and after dialysis
Title
Change in nitrite and nitrate levels in µmol/L
Time Frame
Before, after 30, 60, 120 and 180 minutes and after dialysis
Title
Change in plasma noradrenalin levels in mmol/L
Time Frame
Before, after 30, 60, 120 and 180 minutes and after dialysis
Title
Change in heart rate variability in ms
Time Frame
Before, after 30, 60, 120 and 180 minutes and after dialysis
Title
Change in baroreflex sensitivity in ms/mmHg
Time Frame
Before, after 30, 60, 120 and 180 minutes and after dialysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30134847
Citation
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.
Results Reference
derived

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Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

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