Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

NCT ID: NCT03578510

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-17
• Study Completion Date: 2013-03-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

SHD

Standard hemodialysis

Group Type: ACTIVE_COMPARATOR

Hemocontrol hemodialysis

Intervention Type: 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.

Standard hemodialysis

Intervention Type: 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

Hemocontrol hemodialysis

Group Type: EXPERIMENTAL

Hemocontrol hemodialysis

Intervention Type: 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.

Standard hemodialysis

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

dr. C.F.M. Franssen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 30134847 (View on PubMed)

Other Identifiers

AVPII study

Identifier Type: -

Identifier Source: org_study_id