Table 2.
Schedule of enrolment, intervention and assessments
Study period | ||||||
Time point | Recruitment | Trial visits | ||||
W24† | Active | Washout | ||||
W0 | W2 | W4 | W8 | W12 | ||
Enrolment | ||||||
Screening | X | |||||
Informed consent | X | |||||
Randomisation | X | |||||
Intervention | ||||||
High water intake | ||||||
Ad libitum water intake | ||||||
Assessment | ||||||
Medical history | X | |||||
Medication review | X | X | X | X | X | X |
Physical examination | X | X | X | X | X | X |
Vital signs (blood pressure, pulse rate and oximetry) | X | X | X | X | X | X |
Height | X | |||||
Weight | X | X | X | X | X | X |
Haematology (full blood count) | X | |||||
Biochemistry (urea, creatinine, electrolytes, serum osmolality) | X | X | X | X | X | X |
Biochemistry (liver function and bone profile) | X | |||||
Measured GFR* | X | X | X | |||
Urine SG | X | X | X | X | X | X |
Spot urine osmolality | X | X | X | X | X | X |
24 hours urine collection (volume and osmolality) | X | X | X | X | ||
Home uSG monitoring‡ | X | X | X | X | ||
SPLASH monitoring | X | X | X | X | ||
Dietary assessment | X | X | X | X | ||
Pain questionnaire‡ | X | X | ||||
Acceptability questionnaire‡ | X | X | ||||
EQ5D‡ | X | X |
*51Cr-EDTA measured GFR performed as part of a substudy in eight participants in the HW group.
†24 weeks prestudy recruitment period.
‡Recorded using the DRINK smartphone app.
GFR, glomerular filtration rate; uSG, urine specific gravity.