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Table 1 Schedule of participant investigations and visits

From: Rationale and design of the Sodium Lowering In Dialysate (SoLID) trial: a randomised controlled trial of low versus standard dialysate sodium concentration during hemodialysis for regression of left ventricular mass

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

 

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

 

X

       

History

X

    

X

 

X

 

Physical examination

X

      

X

 

Non-interventional Titration

  

X

      

Dialysate [Na+] Titration

   

X

     

3day food diary

X

    

X

 

X

 

Inter-dialytic urine for Na+ excretion

X

    

X

 

X

 

Cardiac MRI

X

      

X

 

ECF volume

X

   

X

X

X

X

 

BP (intra-dialytic)

X

  

X

X

X

X

X

X

Ambulatory BP (inter-dialytic)

X

      

X

 

Home BP (inter-dialytic)

X

    

X

 

X

 

IDWG

X

  

X

X

X

X

X

 

Antihypertensive medication history

X

   

X

X

X

X

 

Dialysis Thirst Inventory

X

    

X

 

X

 

Short Xerostomia Inventory

X

    

X

 

X

 

Laboratory studies (NT-pro-BNP, hsCRP, urotensin II, plasma γNa / osmolality)

X

   

X

X

X

X

 

Assessment of tolerance to HD

X

  

X

X

X

X

X

X

Arterial compliance (PWV)

X

    

X

 

X

 

Arterial compliance (PWA)

X

   

X

X

X

X

 

Quality of life (KDQOL)

X

      

X

 

Quality of life (EQ-5D)

X

      

X

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