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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06341452
Other study ID # HD-NaM-01-EU
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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