The purpose of the study is to investigate whether oral sodium bicarbonate supplementation to ensure a constant bicarbonate profile in haemodialysis patients will primarily lower predialysis potassium levels and secondary lead to improvements in cardiac function, muscle mass and dialysis related symptoms.
Background: One of the functions of dialysis is to correct electrolyte abnormalities which occur with renal failure, such as variations in potassium and bicarbonate levels, which are linked to important clinical outcomes for patients. Metabolic acidosis, reflected by falling bicarbonate levels, is a frequent event in haemodialysis patients and its correction is one of the goals of effective dialysis. Bicarbonate replacement is routinely delivered during each dialysis session thrice weekly with the use of high dialysate bicarbonate. However, local and national data show that over 50% of patients fail to meet a bicarbonate level within the normal range before each dialysis session. Low predialysis bicarbonate levels of less than 22mmols/L have been linked with increased all-cause mortality in haemodialysis patients. Evidence from previous studies suggests that a continuous replacement (i.e. daily) with oral sodium bicarbonate capsules may be a superior correction of acidosis to the current treatment of intermittent replacement during dialysis. Aims and objectives: This randomised controlled study aims to investigate the effects of oral sodium bicarbonate supplementation on: Primary objective: Pre and post dialysis potassium without increasing intradialytic potassium gradient. Secondary objectives: 1. Risk of arrhythmia as measured by ECG analysis 2. Muscle mass as measured by body composition monitoring 3. Muscle function as measured by handgrip strength 4. Haemodialysis related cramps as measured by a symptom scale-renal questionnaire Patients will be recruited from Imperial College Healthcare NHS (National Heath Service) Trust haemodialysis units and randomised to two equally numbered groups. One group will receive the standard dialysis treatment (control) and the other one will receive the standard dialysis with the addition of capsules of sodium bicarbonate (intervention). The dose of sodium bicarbonate will be adjusted according to individual levels. The study duration is 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
44
Defined by active substance and brand names not specified in protocol
Imperial College Healthcare NHS Trust
London, United Kingdom
pre dialysis potassium level and intradialytic potassium gradient
Measurements over the first 4 weeks to establish blood potassium profile. Measurements over weeks 5-8 to detect early blood changes. Measurement over weeks 13-16 to detect late blood changes.
Time frame: 12 weekly blood tests over a period of 16 weeks
12 lead Electrocardiogram analysis
Electrocardiogram analysis before and after dialysis for the measurement of QT dispersion. Increase of the QT dispersion is linked to risk of ventricular arrhythmias.
Time frame: 3 timepoints (weeks 4, 8 and 16) over a period of 16 weeks
Total body muscle mass
Body composition measurement before dialysis with the validated body composition monitor by Fresenius
Time frame: 2 timepoints (weeks 4 and 16) over a period of 16 weeks
Handgrip strength
Handgrip strength to measure muscle function. Measured before dialysis with the ®Jamar handgrip dynamometer.
Time frame: 2 timepoints (weeks 4 and 16) over a period of 16 weeks
Symptom severity
Haemodialysis related symptoms measured by a validated palliative outcome symptom scale-renal questionnaire (POS-S)
Time frame: 3 timepoints (weeks 4,8 and 16) over a period of 16 weeks
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