Skip to main content
. 2021 May 24;11(5):e047596. doi: 10.1136/bmjopen-2020-047596

Table 2.

Data collection and schedule of assessments

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.