Oral sodium bicarbonate in haemodialysis patients: a randomised controlled trial

Background: Adverse events and mortality tend to cluster around dialysis sessions, potentially due to the impact of the saw-toothed profile of uraemic toxins such as potassium, peaking pre-dialysis and rapidly dropping during dialysis. Acidosis could be contributing to this harm by exacerbating a rise in potassium. The objectives of this study were to investigate the effects of oral bicarbonate treatment on reducing inter-dialytic potassium gain as well as other clinical consequences of preserving muscle mass and function and reducing intradialytic arrhythmia risk in people on haemodialysis. Methods: Open-label randomised controlled trial in a single-centre (London, UK). Forty-three clinically stable adults on haemodialysis were recruited, with a 6 month average pre-dialysis serum bicarbonate level 4mmol/l. Thirty-three participants completed the study. Oral sodium bicarbonate tablets titrated up to a maximum of 3g bd (6g total) in intervention group for 12 weeks versus no treatment in the control group. Outcomes compared intervention versus non-intervention phases in the treated group and equivalent time points in the control group: pre- and post-dialysis serum potassium; nutritional assessments: muscle mass and handgrip strength and electrocardiograms (ECGs) pre and post dialysis. Results: Participants took an average of 3.7±0.5g sodium bicarbonate a day. In the intervention group, inter-dialytic potassium gain was reduced from 1.90±0.60 to 1.69±0.49mmol/l (p=0.032) and pre-dialysis potassium was reduced from 4.96±0.62 to 4.79±0.49mmol/l without dietary change. Pre-dialysis bicarbonate increased from 18.15±1.35 to 20.27±1.88mmol/l, however with an increase in blood pressure. Nutritionally, lean tissue mass was reduced in the controls suggesting less catabolism in the intervention group. There was no change in ECGs. Limitations are small sample size and unblinded study design lacking a placebo, with several participants failing to achieve the target of 22mmol/l serum bicarbonate levels due mainly to tablet burden. Conclusion: Oral sodium bicarbonate reduced bicarbonate loss and potassium gain in the inter-dialytic period, and may also preserve lean tissue mass. Trial registration: The study was registered prospectively on 06/08/2015 with EU Clinical Trials Register EudraCT number 2015-001439-20