Table 2.
Assessment | Time point | |||||
Enrolment | Month 1 | Month 2 | Month 3 | Month 6 | Month 12 | |
Informed consent | X | |||||
Randomisation | X | |||||
Demographic data registration | X | |||||
DDKD aetiology | X | |||||
Medical history data registration and Charlson’s index | X | |||||
Dialysis Symptom Index | X | X | X | X | ||
Depression (PHQ-9) | X | X | X | X | ||
Anxiety (GAD-7) | X | X | X | X | ||
Krurea, Krt/Vurea, RKF (24-hour urine collection or inter-dialytic urine collection)* | X | X | X | X | ||
Adjuvant therapy† | X | X | ||||
spKdt/Vurea, stdKdt/Vurea | X | X | X | X | X | |
Total weekly Kt/Vurea | X | X | X | X | X | |
Blood work (Na, K, TCO2, pre-dialysis BUN, pre-dialysis serum creatinine) | X | X | X | X | X | X |
Post-dialysis BUN | X | X | X | X | X | |
URR | X | X | X | X | X | |
Erythropoietin stimulating agent dose, intravenous iron dose | X | X | X | X | X | |
Haemoglobin, ferritin, transferrin saturation | X | X | X | X | X | |
Serum calcium, phosphorus, PTH intact, albumin, nPCR | X | X | X | X | X | |
Active vitamin D dose | X | X | X | X | X | |
Urine beta-2 microglobulin | X | X | X | X | ||
Serum beta-2 microglobulin, pre-HD and post-HD | X | X | X | X | ||
Renal beta-2 microglobulin clearance | X | X | X | X | ||
Serum creatinine, post-HD | X | X | ||||
Fluid status‡ | X | X | X | X | X | |
Adherence to and compliance with HD treatments§ | X | X | X | X | X | |
Additional HD treatments¶ | X | X | X | X | X | |
ED visits¶ | X | X | X | X | X | |
Hospitalisation (cause, length)¶ | X | X | X | X | X |
Baseline laboratory studies will be considered as the most recent available values within 2 weeks prior to HD initiation.
stdKdt/Vurea month 1, based on average spKdt/Vurea month 1 (weeks 2 and 4); stdKdt/Vurea month 2, based on average spKdt/Vurea month 2 (weeks 6 and 8); stdKdt/Vurea month 3, based on average spKdt/Vurea month 3 (weeks 9 and 12).
Total Kt/Vurea month 1, based on stdKdt/Vurea month 1 and baseline Krt/Vurea; total Kt/Vurea month 2, based on stdKdt/Vurea month 2 and Krt/Vurea obtained during week 6; total Kt/Vurea month 3, based on stdKdt/Vurea month 3 and Krt/Vurea obtained during week 12; total Kt/Vurea month 6, based on stdKdt/Vurea month 6 and Krt/Vurea obtained during week 24; total Kt/Vurea month 12, based on stdKdt/Vurea month 12 and Krt/Vurea obtained during week 48.
*24-hour urine collection will be obtained at baseline (within 2 weeks before or after first HD treatment). This will be used to calculate baseline Krt/Vurea and baseline renal beta-2 microglobulin clearance. Inter-dialytic urine collections will be done at week 6, 12, 24 and 48±7 days. Measurements performed on urine collections will include: urine volume, urine urea, urine creatinine and urine beta-2 microglobulin concentration. With inter-dialytic urine collection, blood work (BUN, serum creatinine and serum beta-2 microglobulin levels) will be done post-HD and pre-HD corresponding to the HD treatments at the beginning and at the end, respectively, of the inter-dialytic collection.
†Adjuvant therapy will include diuretics (loop diuretic±thiazide), patiromer and sodium bicarbonate.
‡Fluid status assessment based on inter-dialytic weight gain (expressed as percentage(%) of estimated dry weight), residual weight (post-dialysis weight—estimated dry weight; expressed as % of estimated dry weight) and ultrafiltration rate (calculated as mL/kg/hour per dialysis session; goal <13 mL/kg/hour).
§Proportion of missed HD treatments and proportion of shortened HD treatments.
¶Requirement of additional HD treatment(s) and/or hospitalisation(s) for fluid or metabolic imbalances.
BUN, blood urea nitrogen; DDKD, dialysis-dependent kidney disease; ED, emergency department; GAD-7, Generalized Anxiety Disorder-7; HD, haemodialysis; KDQOL-SF36, kidney disease quality of life short form 36; Krt/Vurea, residual renal urea clearance; nPCR, normalised catabolic protein rate; PHQ-9, Patient Health Questionnaire-9; RKF, residual kidney function; spKdt/Vurea, single-pool dialysis urea clearance; stdKdt/Vurea, standard dialysis urea clearance; TCO2, total carbon dioxide; URR, urea reduction ratio.