Use of sodium bicarbonate in elderly patients with low grade acidosis and chronic renal disease Introduction The aim of the HTA programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technologies is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis. Question Does the correction of minor degrees of acidosis by oral NaHCO3 in elderly patients with chronic renal disease but not needing dialysis lead to greater benefits than harms 1 Technology: Oral sodium bicarbonate (applicants to define dose). 2 Patient group: Elderly patients with stage 4 or 5 chronic renal failure but not needing dialysis, with plasma bicarbonate less than 22 mmol/l. 3 Setting: Secondary care. 4 Control or comparator treatment: Placebo. 5 Design: A randomised controlled trial comparing oral sodium bicarbonate to placebo. Researchers will define what plasma bicarbonate level would be considered acceptable. 6 Important outcomes: Clinical: quality of life / wellbeing; Biochemical: plasma bicarbonate level, markers of kidney disease, markers of bone mineralisation and metabolism, protein turnover, vitamin D and parathyroid hormone levels. Adverse effects and harms such as heart failure or increased blood pressure. Other Outcomes: Fractures, hospitalisation, and mortality. 7 Minimum duration of follow-up: Two years. Background to commissioning brief: Recent research suggests that 1 in 10 of the population may have chronic kidney disease, the prevalence increasing with age. Metabolic acidosis is noted in many chronic kidney disease (CKD) patients once the glomerular filtration rate decreases to less than 20% to 25% of normal. Oral sodium bicarbonate is increasingly used in patients with chronic renal failure and acidosis who do not need dialysis, but the evidence for the safety and efficacy of this intervention is incomplete. Primary research in the form of a randomised controlled trial is needed to compare oral sodium bicarbonate to placebo to correct minor degrees of acidosis in elderly patients with chronic renal disease but not needing dialysis.
CPV
73110000, 73210000, 85140000
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