End stage renal disease (ESRD) Urological and Genital Diseases Chronic kidney disease, stage 5
Conditions
Interventions
The patient will be on his/her ordinary dialysis schedule during the study period, and treatment parameters like session length, blood flow rate, dialyzer type and size, anticoagulation strategy, and
Sponsors
Gambro Korea Ltd. (Korea, South)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. End stage renal disease (ESRD) 2. Male and female aged 18 or older 3. Treated in HD or HemoDiaFiltration (HDF) mode three times per week since at least 3 months 4. On stable dialysis prescription since at least 1 month (without major changes in dry weight, dialysis fluid conductivity/sodium level, dialyzer type, blood flow rate) 5. Available for treatment with Gambro dialysis machines equipped with the Diascan monitoring tool 6. Signed consent to participate in the study (informed consent)
Exclusion criteria
Exclusion criteria: 1. 24 hour urine volume production estimated to be >100 ml 2. Dialysis prescribed with varying dialysate sodium level (sodium profiling) 3. Considered unable to respond to thirst by free fluid intake 4. Regularly prescribed infusion of Na-containing fluids during or between dialysis session (e.g. saline to manage intradialytic hypotension) 5. Regularly prescribed infusion of albumin solution, e.g. to manage hypoalbuminemia or intradialytic hypotension 6. Pregnancy or planned pregnancy 7. Known hyperproteinemia or hyperlipidemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Initial and final plasma conductivity, as displayed by the Diascan monitoring tool, recorded in all mid-week dialysis sessions during the 6 week study period 2. Body weight post-dialysis for all mid-week dialysis sessions and pre-dialysis for all subsequent dialysis sessions during the 6 week study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Initial and final plasma conductivity levels during the dialysis session 2. Plasma sodium levels pre- and post-dialysis 3. Plasma osmolarity level pre- and post-dialysis 4. Intradialytic change in plasma sodium 5. Dialysis fluid to plasma sodium gradient at start of dialysis 6. Body weight pre and post dialysis and pre dialysis at the following dialysis session 7. Need for saline infusion (isotonic saline or hypertonic solution) during the dialysis session 8. Recording of potential safety events | — |
Countries
Korea, South
Outcome results
None listed