Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis

Not Applicable

Not yet recruiting

• Conditions: End Stage Renal Disease
• Interventions: Device: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control

• Registration Number: NCT06341452
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-30
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Study Start: 2024-06
• Primary Completion: 2025-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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).

Exclusion Criteria

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
• Dry weight < 40kg
• Active or chronic infections (HIV, SARS-CoV-2, HBV, HCV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Na zero-diffusive treatment	Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control	Patients will be treated for 12 weeks sodium zero-diffusive prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.
standard treatment without Na-control	Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control	Patients will be treated for 12 weeks either with standard dialysate prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.

Primary Outcome Measures

Name	Time	Method
Intradialytic hemodynamic stability	12 weeks after start of study	Evaluation of the impact of sodium zero-diffusive dialysis on intradialytic hemodynamic stability will be analyzed based on frequency of intradialytic hypertensive episodes
Fluid status	12 weeks after start of study	Evaluation of the impact of sodium zero-diffusive dialysis on fluid status will be analyzed with regard to dry weight (kg)
Interdialytic weight gain	12 weeks after start of study	Evaluation of the impact of sodium zero-diffusive dialysis on interdialytic weight gain will be analyzed in kg and % of dry weight
Intradialytic morbid events	12 weeks after start of study	Evaluation of the impact of sodium zero-diffusive dialysis on the frequency of intradialytic morbid events will be analyzed

Secondary Outcome Measures

Name	Time	Method
PRO: Thirst feeling	12 weeks after start of study	Evaluation of thirst feeling will be assessed via the Xerostomia Inventory
PRO: HRQOL	12 weeks after start of study	Evaluation of health related quality of life (HRQOL) will be assessed using the validated Kidney Disease Quality of Life (KDQOL) survey KDQOL-36
PRO: Hypotensive episodes	12 weeks after start of study	Evaluation of hypotensive episodes will be assessed via the CONVINCE intradialytic symptoms (IDS) Scale - hypotensive episodes items
PRO: Health status	12 weeks after start of study	Evaluation of health status will be assessed via the validated EQ-5D-5L survey by EuroQol group
PRO: Fatigue	12 weeks after start of study	Evaluation of fatigue will be assessed via the CONVINCE Dialysis Fatigue Scale (CFDS-10)