Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis

End Stage Renal Disease Clinical Trial

— SODIAH  

Official title:

Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06341452
• Other study ID #: HD-NaM-01-EU
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: Jennifer Braun, Dr.
• Phone: +49 6172 608 93488
• Email: Jennifer.Braun[@]freseniusmedicalcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control
Patients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Outcome

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