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Compares treatment options for End Stage Renal Disease
Official title Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis
ClinicalTrials.gov ID: NCT06341452
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Participation in an treatment clinical study during the preceding 30 days
- Previous participation in the same study Study-specific:
See the full eligibility 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...
- 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 treatment 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)
The study team makes the final eligibility decision.
Where it's taking place
- Mariánské Lázně, Czechia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mariánské Lázně, Czechia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.