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Table 1 Overview of enrolment, interventions, and assessments according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement

From: Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): study protocol for a randomized controlled crossover trial

 

Study period

Recruitment

Allocation

Post-allocation

Close-out

Time point

−t1

0

t1

t2

t3

t4

t5

t6

Recruitment

        

► Eligibility

x

       

► Informed consent

x

       

► Allocation

 

x

      

Interventions

        

► Optimized APD

   

x

x

   

► Standard APD

   

x

x

   

Assessments

        

► 4 h D/P creatinine

 

x

      

► Urea DV

 

x

      

► Glucose absorption

   

x

x

   

► UF and NaR

   

x

x

   

► Blood chemistry

  

x

x

x

x

  

► Physical examination

  

x

x

x

x

x

 

► Kt/V urea+crea

   

x

x

   

► Adverse events

   

x

x

x

x

x

  1. DV distribution volume, D/P dialysate-over-plasma concentration ratio, UF net drained volume, NaR sodium removal, Kt/V calculated from net urea removal divided by plasma urea concentration and DV
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Pilot and Feasibility Studies

ISSN: 2055-5784