Oral sodium bicarbonate supplementation in haemodialysis patients
Research type
Research Study
Full title
A Feasibility Randomised Controlled Trial: Effects of Oral Sodium Bicarbonate Supplementation in Patients on Haemodialysis
IRAS ID
174795
Contact name
Damien Ashby
Contact email
Sponsor organisation
Joint Research Complicance Office, Imperial College London and Imperial College NHS Trust
Eudract number
2015-001439-20
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
This study aims to investigate the effects of a constant bicarbonate profile by providing oral sodium bicarbonate supplementation on cardiac function, nutritional status and symptoms in patients on haemodialysis. Kidney failure can cause acid to build up in the blood and this is called acidosis. Acidosis affects potassium levels and as a result may be indirectly associated with an increased risk of abnormal heart rhythms and sudden cardiac death. It has also been shown to contribute to muscle breakdown. Changes in potassium levels around the time of haemodialysis may also play a role in symptoms such as cramps. Acidosis is corrected during dialysis with a solution containing bicarbonate three times a week. However, a large number of patients may still have low bicarbonate levels before their next dialysis session. 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.
Patients will be recruited from Imperial College Healthcare NHS Trust haemodialysis units and randomly allocated 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. Adult patients with no active infections or cancer diagnosis and whose potassium and bicarbonate blood levels meet the inclusion criteria will be eligible for the study. The study duration is 16 weeks. Patients will have several assessments done throughout the study. These include blood samples, electrocardiogram tests, body composition monitor, handgrip strength, symptom questionnaire and nutritional assessment. The study is funded by Imperial Biomedical Research Centre.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/1011
Date of REC Opinion
21 Jul 2015
REC opinion
Further Information Favourable Opinion