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Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis (the BiCARB trial)? Study protocol for a randomized controlled trial.

Witham MD, Band MM, Littleford RC, Avenell A, Soiza RL, McMurdo ME, Sumukadas D, Ogston SA, Lamb EJ, Hampson G, McNamee P, BiCARB Study Gro - Trials (2015)

Bottom Line: Markers of bone turnover (25-hydroxyvitamin D, 1,25-hydroxyvitamin D, tartrate-resistant acid phosphatase-5b and bone-specific alkaline phosphatase) and vascular health (B-type natriuretic peptide) will be measured.Participants will receive a total of 24 months of either bicarbonate or placebo.The results will provide the first robust test of the overall clinical and cost-effectiveness of this commonly used therapy in older patients with severely reduced kidney function. www.isrctn.com; ISRCTN09486651, registered 17 February 2012.

View Article: PubMed Central - PubMed

Affiliation: Medical Research Institute, University of Dundee, Ninewells Hospital, Dundee, DD1 9SY, UK. m.witham@dundee.ac.uk.

ABSTRACT

Background: Metabolic acidosis is more common with advancing chronic kidney disease, and has been associated with impaired physical function, impaired bone health, accelerated decline in kidney function and increased vascular risk. Although oral sodium bicarbonate is widely used to correct metabolic acidosis, there exist potential risks of therapy including worsening hypertension and fluid overload. Little trial evidence exists to decide whether oral bicarbonate therapy is of net benefit in advanced chronic kidney disease, particularly in older people who are most commonly affected, and in whom physical function, quality of life and vascular health are at least as important outcomes as decline in renal function.

Methods/design: BiCARB is a multi-centre, double-blind, placebo controlled, randomised trial evaluating the clinical and cost-effectiveness of oral sodium bicarbonate in the management of older people with chronic kidney disease and severely reduced glomerular filtration rate (GFR) who have a mild degree of metabolic acidosis. The trial will recruit 380 patients from renal, Medicine for the Elderly, and primary care services across centres in the United Kingdom. Male and female patients aged 60 years and older with an estimated glomerular filtration rate of <30 mL/min/1.73 m(2), not on dialysis, and with serum bicarbonate concentrations <22 mmol/L will be eligible for participation. The primary clinical outcome for the trial is the between-group difference in the Short Physical Performance Battery score at 12 months. Secondary outcomes include muscle strength, quality of life measured using the EQ-5D score and KDQoL tools, cost effectiveness, renal function, presence of albuminuria and blood pressure. Markers of bone turnover (25-hydroxyvitamin D, 1,25-hydroxyvitamin D, tartrate-resistant acid phosphatase-5b and bone-specific alkaline phosphatase) and vascular health (B-type natriuretic peptide) will be measured. Participants will receive a total of 24 months of either bicarbonate or placebo. The results will provide the first robust test of the overall clinical and cost-effectiveness of this commonly used therapy in older patients with severely reduced kidney function.

Trial registration: www.isrctn.com; ISRCTN09486651, registered 17 February 2012.

No MeSH data available.


Related in: MedlinePlus

Participant flow through trial
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Related In: Results  -  Collection

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Fig1: Participant flow through trial

Mentions: Adverse events and medication changes will be sought at each study visit, as will data on hospitalisation, death (all-cause, cardiovascular and renal), commencement of renal replacement therapy, fractures, primary care and secondary care outpatient visits via participant health-utilisation diaries. Adherence to medication will be assessed by tablet count on bottles returned to the trial pharmacy. Detailed information on medical history, concomitant medications (including renal and cardiovascular medications such as renin-angiotensin system blockers), social and functional history will be collected at baseline. Participant flow through the trial is outlined in Fig. 1.


Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis (the BiCARB trial)? Study protocol for a randomized controlled trial.

Witham MD, Band MM, Littleford RC, Avenell A, Soiza RL, McMurdo ME, Sumukadas D, Ogston SA, Lamb EJ, Hampson G, McNamee P, BiCARB Study Gro - Trials (2015)

Participant flow through trial
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4522127&req=5

Fig1: Participant flow through trial
Mentions: Adverse events and medication changes will be sought at each study visit, as will data on hospitalisation, death (all-cause, cardiovascular and renal), commencement of renal replacement therapy, fractures, primary care and secondary care outpatient visits via participant health-utilisation diaries. Adherence to medication will be assessed by tablet count on bottles returned to the trial pharmacy. Detailed information on medical history, concomitant medications (including renal and cardiovascular medications such as renin-angiotensin system blockers), social and functional history will be collected at baseline. Participant flow through the trial is outlined in Fig. 1.

Bottom Line: Markers of bone turnover (25-hydroxyvitamin D, 1,25-hydroxyvitamin D, tartrate-resistant acid phosphatase-5b and bone-specific alkaline phosphatase) and vascular health (B-type natriuretic peptide) will be measured.Participants will receive a total of 24 months of either bicarbonate or placebo.The results will provide the first robust test of the overall clinical and cost-effectiveness of this commonly used therapy in older patients with severely reduced kidney function. www.isrctn.com; ISRCTN09486651, registered 17 February 2012.

View Article: PubMed Central - PubMed

Affiliation: Medical Research Institute, University of Dundee, Ninewells Hospital, Dundee, DD1 9SY, UK. m.witham@dundee.ac.uk.

ABSTRACT

Background: Metabolic acidosis is more common with advancing chronic kidney disease, and has been associated with impaired physical function, impaired bone health, accelerated decline in kidney function and increased vascular risk. Although oral sodium bicarbonate is widely used to correct metabolic acidosis, there exist potential risks of therapy including worsening hypertension and fluid overload. Little trial evidence exists to decide whether oral bicarbonate therapy is of net benefit in advanced chronic kidney disease, particularly in older people who are most commonly affected, and in whom physical function, quality of life and vascular health are at least as important outcomes as decline in renal function.

Methods/design: BiCARB is a multi-centre, double-blind, placebo controlled, randomised trial evaluating the clinical and cost-effectiveness of oral sodium bicarbonate in the management of older people with chronic kidney disease and severely reduced glomerular filtration rate (GFR) who have a mild degree of metabolic acidosis. The trial will recruit 380 patients from renal, Medicine for the Elderly, and primary care services across centres in the United Kingdom. Male and female patients aged 60 years and older with an estimated glomerular filtration rate of <30 mL/min/1.73 m(2), not on dialysis, and with serum bicarbonate concentrations <22 mmol/L will be eligible for participation. The primary clinical outcome for the trial is the between-group difference in the Short Physical Performance Battery score at 12 months. Secondary outcomes include muscle strength, quality of life measured using the EQ-5D score and KDQoL tools, cost effectiveness, renal function, presence of albuminuria and blood pressure. Markers of bone turnover (25-hydroxyvitamin D, 1,25-hydroxyvitamin D, tartrate-resistant acid phosphatase-5b and bone-specific alkaline phosphatase) and vascular health (B-type natriuretic peptide) will be measured. Participants will receive a total of 24 months of either bicarbonate or placebo. The results will provide the first robust test of the overall clinical and cost-effectiveness of this commonly used therapy in older patients with severely reduced kidney function.

Trial registration: www.isrctn.com; ISRCTN09486651, registered 17 February 2012.

No MeSH data available.


Related in: MedlinePlus