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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Na zero-diffusive treatment | Other | Patients will be treated for 12 weeks sodium zero-diffusive prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient. |
|
| standard treatment without Na-control | Other | Patients will be treated for 12 weeks either with standard dialysate prescription thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control | Device | Patients will be treated for 12 weeks thrice weekly Hemodialysis or Hemodiafiltration sessions resulting in 36 sessions per patient. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PRO: Thirst feeling | Evaluation of thirst feeling will be assessed via the Dialysis Thirst Inventory | 12 weeks after start of study |
| PRO: Thirst feeling | Evaluation of thirst feeling will be assessed via the Xerostomia Inventory |
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Inclusion Criteria:
General:
Study-specific:
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:
Study-specific:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Braun, Dr. | Contact | +49 6172 608 93488 | Jennifer.Braun@freseniusmedicalcare.com | |
| Manuela Stauss-Grabo, Dr. | Contact | +4961726085248 | Manuela.Stauss-Grabo1@freseniusmedicalcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Martin Jirovec, Dr. | Fresenius Medical Care - DS, s.r.o., Marianske Lazne; Czech Republic | Principal Investigator |
| Björn Meijers, Prof. Dr. | Universitaire Ziekenhuizen Leuven, Leuven, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresenius Medical Care- DS, s.r.o. | Recruiting | Mariánské Lázně | 35301 | Czechia |
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Prospective, open, controlled, parallel, randomized, interventional, multi-center, explorative
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| 12 weeks after start of study |
| PRO: Fatigue | Evaluation of fatigue will be assessed via the CONVINCE Dialysis Fatigue Scale (CFDS-10) | 12 weeks after start of study |
| 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 |
| 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 |
| 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 |
| Maria Jesus Izquierdo Ortiz, Dr. | Burgos University Hospital, Burgos, Spain | Principal Investigator |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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