This Study Evaluates the Impact of the Sodium Management Tool (SMT) on Hemodialysis Patient Outcomes Compared to Standard Care

NCT06896786 | Not Yet Recruiting

• 1 other identifier: NEP-LU-0001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Title of the Study: Sodium Management Tool in Hemodialysis Patients Brief Summary: The goal of this clinical trial is to learn whether the Sodium Management Tool (SMT) can improve patients clnical outcomes. The main questions this study aims to answer are: Does the SMT help reduce weight gain between dialysis sessions? Does the SMT improve dialysis tolerance by reducing symptoms like low blood pressure and muscle cramps? Researchers will compare standard dialysis to dialysis using the SMT to see if clinical outcomes are better in dialysis that use the SMT. Participants will: Receive dialysis three times per week with either standard dialysis or SMT-activated dialysis Switch between standard dialysis and SMT-activated dialysis after 4 weeks Have their blood pressure, sodium levels, and symptoms monitored during treatment Report their symptoms and thirst levels in a questionnaire Some participants may continue for an additional 4 weeks with a personalized SMT setting based on their symptoms and weight changes. This study will help determine whether the SMT can improve sodium balance and make dialysis more comfortable for patients.

Conditions

Hemodialysis; Interdialytic Weight Gain; Intradialytic Hypotension

Keywords

sodium management in hemodialyis patients; management of complaints in hemodialysis patients; interdialytic weight gain; intradialytic hypotension; sodium management tool

Outcome Measures

Primary Outcomes (1)

• mean relative interdialytic weight gain (rIDWG)

  The primary endpoint is the mean relative interdialytic weight gain (rIDWG) measured in the last week of each study period. Interdialytic weight gain (IDWGt): Weight measured at the beginning of the dialysis at time t minus weight measured after the dialysis at time t-1 (weight pre-dialysis t - weight post-dialysis t-1) Relative interdialytic weight gain (rIDWGt)): Difference of the weight measured at the beginning of the dialysis at time t and the weight measured after the dialysis at time t-1, divided by the weight measured after the dialysis at time t-1 ((weight pre-dialysis t - weight postdialysis t-1) / weight post-dialysis t-1)

  measured in the last week of each study period (week 4 ,8 ,12)

Secondary Outcomes (3)

• dialysis tolerance with and without SMT based on dialysis symptom index (DSI)

  measured in the last week of each study period (week 4, 8 and 12)

• dialysis tolerance with and without SMT based on Visual Analogue Scale (VAS ) Dialysis tolerance:

  measured in the last week of each study period (week 4, 8 and 12)

• Thirst Intensity with and without SMT based on VAS thirst intensity

  measured in the last week of each study period (week 4, 8 and 12)

Study Arms (2)

Standard of care

NO INTERVENTION

dialysis conducted with standard of care

dialysis assisted with the sodium management tool

ACTIVE COMPARATOR

dialysis assisted with the sodium management tool

Other: dialysis assisted with the sodium management tool

Interventions

dialysis assisted with the sodium management tool OTHER

Sodium management tool is a modul of the fresenius 6008 dialysis machine. This model approximates changes in plasma electrolyte concentrations during dialysis and allows the estimation of sodium concentration based on dialysate conductivity. Na control biosensor continuously (every minute) monitors the dialysate side sodium balance based on measurements of fresh and spent dialysate conductivities and the application of a kinetic model to account for the typical influence of other ions on dialysate conductivity. In activated Na control, as "zero diffusive" mode, dialysate sodium is then adjusted continuously to minimize diffusive Na transfer. SMT is part of the 6008 Machine and its certification is included in the Fresenius 6008 Machine certification. Untill now there is no data if this modul benefits. in this study the investigator compares standard of care dialysis (Arm 1) with dialysis assisted with the SMT (Arm ) on clinical outcome

dialysis assisted with the sodium management tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients on hemodialysis for at least three months,
• Dialysis three times a week, age \>/= 18,
• dialysis with a Fresenius 6008 Machine,
• signed informed consent

You may not qualify if:

• Dialysis access with repeated Interruption due to flow problems
• plasma natrium \< 130 mmol/l, \> 145 mmol/l, pregnancy -

Sponsors & Collaborators

• Sharon-Rose Maloney: lead

Study Officials

• Balthasar Hug, Professor

  LUKS Luzern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon-Rose Maloney, MD

CONTACT

+41 412055150; sharon-rose.maloney@luks.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: randomised, cross over , single site design

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share