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Table 2 Outcome measures and measurement points

From: Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis (the BiCARB trial)? Study protocol for a randomized controlled trial

OUTCOME

TIMELINE

 

Screening

Baseline

3 months

6 months

12 months

18 months

24 months

Informed Consent

X

      

Inclusion/Exclusion Criteria

X

      

Medical History/Demographics

X

      

Adverse Events Recorded

 

X

X

X

X

X

X

Physical function measures

Short Physical Performance Battery

 

X

X

X

X

 

X

Hand Grip Strength

 

X

X

X

X

 

X

Six Minute Walk Test

 

X

X

X

X

 

X

Blood measures

Sodium

X

X

X

X

X

 

X

Potassium

X

X

X

X

X

 

X

Creatinine

X

X

X

X

X

 

X

Urea

X

X

X

X

X

 

X

Bicarbonate

X

X

X

X

X

 

X

Estimated GFR

X

X

X

X

X

 

X

Calcium

 

X

X

X

X

 

X

Phosphate

 

X

X

X

X

 

X

Alkaline phosphatase

 

X

X

X

X

 

X

Magnesium

 

X

X

X

X

 

X

Albumin

 

X

X

X

X

 

X

Haemoglobin

 

X

X

X

X

 

X

Thyroid function

 

X

X

X

X

 

X

HbA1c

 

X

X

X

X

 

X

Total Cholesterol

 

X

X

X

X

 

X

Cystatin C

 

X

X

X

X

 

X

Study Biobank Samples

 

X

X

X

X

 

X

Urine Sample

Protein/creatinine ratio

 

X

X

X

X

 

X

Albumin/creatinine ratio

 

X

X

X

X

 

X

Questionnaires

EQ-5D

 

X

X

X

X

 

X

KDQoL

 

X

X

X

X

 

X

Health Diary

 

X

X

X

X

 

X

Falls Diary

 

Xa

X

X

X

X

X

Anthropometric Measurements

Mid-arm Circumference

 

X

X

X

X

 

X

Triceps Skin Fold Thickness

 

X

X

X

X

 

X

Mid-thigh Circumference

 

X

X

X

X

 

X

Height

 

X

     

Weight

 

X

X

X

X

 

X

Vascular measures

Blood pressure and pulse

X

X

X

X

X

 

X

B-type natriuretic peptide

 

X

  

X

 

X

Bone and calcium metabolism

Calcium

 

X

X

X

X

 

X

Phosphate

 

X

X

X

X

 

X

Parathyroid hormone

 

X

  

X

 

X

25-hydroxyvitamin D

 

X

  

X

 

X

1,25 hydroxyvitamin D

 

X

  

X

 

X

Tartrate-resistant acid phosphatase-5b

 

X

  

X

 

X

Bone-specific alkaline phosphatase

 

X

  

X

 

X

  1. aadministered at baseline but not recorded until 3 months