Visit window (Days) | 0 to28 | 28 | 28 to 42 | 42 up to 70 | 108 to 128 | 198 to 218 | 288 to 308 | 378 to 398 | +7 up to +21 |
---|---|---|---|---|---|---|---|---|---|
Visit name | BA/BR | Â | T0 | T1-T8 | F3 | F6 | F9 | F12/F12R | E1-E4 |
Study phase | Baseline assessment and results | Randomization | Titration (weekly) | Follow-up (3 monthly) | End (weekly) | ||||
Randomization | Â | X | Â | Â | Â | Â | Â | Â | Â |
History | X | Â | Â | Â | Â | X | Â | X | Â |
Physical examination | X | Â | Â | Â | Â | Â | Â | X | Â |
Non-interventional Titration | Â | Â | X | Â | Â | Â | Â | Â | Â |
Dialysate [Na+] Titration | Â | Â | Â | X | Â | Â | Â | Â | Â |
3day food diary | X | Â | Â | Â | Â | X | Â | X | Â |
Inter-dialytic urine for Na+ excretion | X | Â | Â | Â | Â | X | Â | X | Â |
Cardiac MRI | X | Â | Â | Â | Â | Â | Â | X | Â |
ECF volume | X | Â | Â | Â | X | X | X | X | Â |
BP (intra-dialytic) | X | Â | Â | X | X | X | X | X | X |
Ambulatory BP (inter-dialytic) | X | Â | Â | Â | Â | Â | Â | X | Â |
Home BP (inter-dialytic) | X | Â | Â | Â | Â | X | Â | X | Â |
IDWG | X | Â | Â | X | X | X | X | X | Â |
Antihypertensive medication history | X | Â | Â | Â | X | X | X | X | Â |
Dialysis Thirst Inventory | X | Â | Â | Â | Â | X | Â | X | Â |
Short Xerostomia Inventory | X | Â | Â | Â | Â | X | Â | X | Â |
Laboratory studies (NT-pro-BNP, hsCRP, urotensin II, plasma γNa / osmolality) | X |  |  |  | X | X | X | X |  |
Assessment of tolerance to HD | X | Â | Â | X | X | X | X | X | X |
Arterial compliance (PWV) | X | Â | Â | Â | Â | X | Â | X | Â |
Arterial compliance (PWA) | X | Â | Â | Â | X | X | X | X | Â |
Quality of life (KDQOL) | X | Â | Â | Â | Â | Â | Â | X | Â |
Quality of life (EQ-5D) | X | Â | Â | Â | Â | Â | Â | X | Â |