Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis

NCT06341452 | Recruiting

• 1 other identifier: HD-NaM-01-EU
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing.

Conditions

End Stage Renal Disease

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (6)

• Interdialytic weight gain

  Evaluation of the impact of sodium zero-diffusive dialysis on interdialytic weight gain will be analyzed in kg and % of dry weight

  12 weeks after start of study

• Intradialytic hemodynamic stability

  Evaluation of the impact of sodium zero-diffusive dialysis on intradialytic hemodynamic stability will be analyzed based on frequency of intradialytic hypotensive episodes

  12 weeks after start of study

• Intradialytic hemodynamic stability

  Evaluation of the impact of sodium zero-diffusive dialysis on intradialytic hemodynamic stability will be analyzed based on frequency of intradialytic hypertensive episodes

  12 weeks after start of study

• Intradialytic morbid events

  Evaluation of the impact of sodium zero-diffusive dialysis on the frequency of intradialytic morbid events will be analyzed

  12 weeks after start of study

• Fluid status

  Evaluation of the impact of sodium zero-diffusive dialysis on fluid status will be analyzed with regard to overhydration (L)

  12 weeks after start of study

• Fluid status

  Evaluation of the impact of sodium zero-diffusive dialysis on fluid status will be analyzed with regard to dry weight (kg)

  12 weeks after start of study

Secondary Outcomes (6)

• PRO: Thirst feeling

  12 weeks after start of study

• PRO: Thirst feeling

  12 weeks after start of study

• PRO: Fatigue

  12 weeks after start of study

• PRO: Hypotensive episodes

  12 weeks after start of study

• PRO: HRQOL

  12 weeks after start of study

Study Arms (2)

Na zero-diffusive treatment

OTHER

Patients will be treated for 12 weeks sodium zero-diffusive prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.

Device: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control

standard treatment without Na-control

OTHER

Patients will be treated for 12 weeks either with standard dialysate prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.

Device: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control

Interventions

Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control DEVICE

Patients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.

Na zero-diffusive treatment; standard treatment without Na-control

Eligibility Criteria

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

You may qualify if:

• General:
• Informed consent signed and dated by study patient and authorized physician
• Minimum age of 18 years
• The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her/his consent for participation in the clinical trial
• Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on dialysis as extracorporeal renal replacement therapy.
• Study-specific:
• Patients on dialysis (HD/HDF), at least 4h treatment time thrice weekly ≥ 3 months using a standard dialysate with a prescribed sodium concentration of 136 mmol/L
• Anuric patients (\<300mL/d; 1 measurement within last 4 weeks)
• Patient fulfils one of the four following criteria:
• interdialytic weight gain over 4% of dry weight (mean value during run-in period) OR pre-dialytic systolic blood pressure over 180 mmHg (mean value during run-in period) OR intradialytic morbid events (hypotension, hypertension, cramps, headache) in at least three sessions during run-in period OR volume overload according to BCM (FO ≥2.5 L pre-dialysis or relative FO pre-dialysis ≥15% for men and ≥13% for women; one measurement during run-in period)
• \- Patients with a diffusive Na load of at least 1 mmoL/(L TBW) or 0.06g NaCl/(L TBW) (mean value during the run-in period).

You may not qualify if:

• General:
• Any conditions which could interfere with the patient's ability to comply with the study
• Patient is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
• In case of female patients: pregnancy (pregnancy test will be conducted at start and end of study with female patients aged ≤55 years) or lactation period
• Participation in an interventional clinical study during the preceding 30 days
• Previous participation in the same study
• Study-specific:
• Patients treated with individualized sodium management over the last 3 months
• Severe hypoalbuminemia (≤30 g/L; 1 measurement within last 4 weeks)
• Hypernatremia (pre-dialytic plasma sodium concentration ≥145mmol/L; 1 measurement within last 4 weeks)
• Uncontrolled diabetic patients with glycated hemoglobin (HbA1C) \>8%; 1 measurement within last 4 weeks
• Impossible reliable measurement of the different compartments by bioimpedance due to lower limb amputation or wearing of a unipolar pacemaker or metallic prostheses
• Life expectancy less than 6 months
• ONLINEplus HF treatments/hemofiltration treatments
• Single-needle treatments

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (1)

Fresenius Medical Care- DS, s.r.o.

Mariánské Lázně, 35301, Czechia

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Martin Jirovec, Dr.

  Fresenius Medical Care - DS, s.r.o., Marianske Lazne; Czech Republic

  PRINCIPAL INVESTIGATOR

• Björn Meijers, Prof. Dr.

  Universitaire Ziekenhuizen Leuven, Leuven, Belgium

  PRINCIPAL INVESTIGATOR

• Maria Jesus Izquierdo Ortiz, Dr.

  Burgos University Hospital, Burgos, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Braun, Dr.

CONTACT

+49 6172 608 93488; Jennifer.Braun@freseniusmedicalcare.com

Manuela Stauss-Grabo, Dr.

CONTACT

+4961726085248; Manuela.Stauss-Grabo1@freseniusmedicalcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open, controlled, parallel, randomized, interventional, multi-center, explorative

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: April 2, 2024
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)