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. 2018 May 9;8(5):e022859. doi: 10.1136/bmjopen-2018-022859

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.