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Table 1 Schedule of visits and procedures

From: Rationale and design of BISTRO: a randomized controlled trial to determine whether bioimpedance spectroscopy-guided fluid management maintains residual kidney function in incident haemodialysis patients

 

VISITS (Months) All undertaken at routine dialysis sessions

Urine Collections

Trial completion

Event based

Procedure

Visit −1

BaselineVisit 0

Visit 1

Visit 2

Visit 3

Visits 4–11 At 6,9,12,15,18,21,24 Months.

At 5,7,9,11,13,15,17,19,21,23,24 months. includes extra 2 weeks after primary endpoint is reached

  

Eligibility

x

        

Consent

x

        

Residual kidney function tests for normalized GFR (urine volume and urine + blood to lab)

x

 

x

x

x

 

x

  

Height (cm)

x

        

Web-based randomisation

 

x

       

Date of birth

 

x

       

Ethnicity

 

x

       

Sex

 

x

       

Full medication list

 

x

       

Primary Renal Disease Diagnosis

 

x

       

Stoke comorbidity score

 

x

       

Renal Registry comorbidity fields

 

x

       

Planned/unplanned start

 

x

       

Access type (fistula/graft/line)

 

x

       

HD modality: (HD, HDF)

 

x

       

Incremental/full start dialysis

 

x

       

Transplant wait listed

 

x

       

Dialysis prescription

 

x

       

Bioimpedence with full dataset using software

 

x

x

x

x

x

  

x if indicated

BISTRO Study intervention record

 

x

x

x

x

x

  

x if indicated

Duke Activity Status Index (ASI)

 

x

  

x

x

   

Patient Activation Measure (PAM)

 

x

  

x

x

   

EQ-5D-5 L

 

x

  

x

x

   

IPOS-Renal patient version

 

x

  

x

x

   

Haemodialysis symptoms questionnaire

 

x

  

x

x

   

Short Form (SF-12) Health Survey

 

x

  

x

x

   

CSRI CKD

 

x

  

x

x

   

Cognitive Assessment (MoCA)

 

x

    

x annually

  

Study Termination/completion form

       

x

x

Adverse events

        

x