Effects of Oral Sodium Bicarbonate Supplementation in Haemodialysis Patients (BicHD)
Condition: End-stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): sodium bicarbonate 500mg capsules
Intervention type(s): Drug
Intervention description(s): Defined by active substance and brand names not specified in protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Haemodialysis; sodium bicarbonate; potassium; arrhythmia; muscle; symptoms