Individualized sodium management versus standard treatment in hemodialysis

Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis

This study will test whether personalized sodium control during hemodialysis helps people with end-stage kidney disease reduce weight gain between sessions and have fewer blood pressure or heart-related problems during dialysis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fresenius Medical Care Deutschland GmbH (industry)
• Locations: 1 site (Mariánské Lázně)
• Trial ID: NCT06341452 on ClinicalTrials.gov

What this trial studies

Participants on maintenance hemodialysis or hemodiafiltration will receive treatment either with an isonatremic (sodium zero-diffusive) setting enabled on the dialysis machine or with standard dialysis without the sodium-control option. The trial compares the machine's sodium-management option turned on versus off using Fresenius 6008 HD machines and collects clinical performance data alongside patient-reported quality of life measures. Key outcomes include interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events. Data will be used to determine whether individualized sodium management improves stability and symptoms during and between sessions.

Who should consider this trial

Good fit: Adults (≥18) with end-stage renal disease on thrice-weekly hemodialysis or hemodiafiltration for at least three months, anuric (<300 mL/day), receiving ≥4-hour treatments with a prescribed dialysate sodium of 136 mmol/L and meeting predefined interdialytic weight gain or high pre-dialysis blood pressure criteria are ideal candidates.

Not a fit: Patients with substantial residual urine output, those not on thrice-weekly in-center HD/HDF, or those who do not meet the weight-gain or blood-pressure entry criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, personalized sodium control during dialysis could reduce fluid overload between sessions, decrease intradialytic blood pressure instability, and improve symptoms and quality of life.

How similar studies have performed: Previous studies of individualized or isonatremic dialysis have shown mixed results, with some reports of reduced interdialytic weight gain and improved hemodynamic stability while others found limited or inconsistent benefits.

Eligibility criteria

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)

Where this trial is running

Mariánské Lázně

• Fresenius Medical Care- DS, s.r.o. — Mariánské Lázně, Czechia (RECRUITING)

Study contacts

• Principal investigator: Martin Jirovec, Dr. — Fresenius Medical Care - DS, s.r.o., Marianske Lazne; Czech Republic
• Study coordinator: Jennifer Braun, Dr.

Conditions: End Stage Renal Disease, Hemodialysis