End Stage Renal Disease
Conditions
Keywords
Hemodialysis
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.
Interventions
DEVICEHemodialysis 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.
Sponsors
Fresenius Medical Care Deutschland GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, open, controlled, parallel, randomized, interventional, multi-center, explorative
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 hypotensive episodes |
| 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 |
| 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 overhydration (L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PRO: Thirst feeling | 12 weeks after start of study | Evaluation of thirst feeling will be assessed via the Dialysis Thirst Inventory |
| 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) |
| 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: 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 |
Countries
Czechia
Contacts
Primary ContactJennifer Braun, Dr.
Backup ContactManuela Stauss-Grabo, Dr.
Outcome results
None listed