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

BiCARB Study Group

Research output: Contribution to journalArticle

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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 UK centres. Male and female patients aged 60 years and over with estimated glomerular filtration rate of <30 mL/min/1.73m2, 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.
Original languageEnglish
Article number326
Number of pages9
JournalTrials
Volume16
Early online date1 Aug 2015
DOIs
Publication statusPublished - 1 Aug 2015

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Sodium Bicarbonate
Acidosis
Chronic Renal Insufficiency
Randomized Controlled Trials
Quality of Life
Kidney
Bicarbonates
Cost-Benefit Analysis
Blood Vessels
Glomerular Filtration Rate
Health
Placebos
Therapeutics
Bone and Bones
Albuminuria
Bone Remodeling
Brain Natriuretic Peptide
Muscle Strength
Alkaline Phosphatase
Dialysis

Keywords

  • older
  • bicarbonate
  • metabolic acidosis
  • physical function
  • quality of life
  • chronic kidney disease
  • randomised controlled trial

Cite this

@article{a8783a77926f4ffaa726b07391a91e7d,
title = "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",
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 UK centres. Male and female patients aged 60 years and over with estimated glomerular filtration rate of <30 mL/min/1.73m2, 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.",
keywords = "older, bicarbonate, metabolic acidosis, physical function, quality of life, chronic kidney disease, randomised controlled trial",
author = "Witham, {Miles D} and Band, {Margaret M} and Littleford, {Roberta C} and Alison Avenell and Soiza, {Roy L} and McMurdo, {Marion E T} and Deepa Sumukadas and Ogston, {Simon A} and Lamb, {Edmund J} and Geeta Hampson and Paul MacNamee and {BiCARB Study Group}",
note = "Date of acceptance: 01/07/2015 {\circledC} 2015 Witham et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Acknowledgements UK NIHR HTA grant 10/71/01. We acknowledge the financial support of NHS Research Scotland in conducting this trial.",
year = "2015",
month = "8",
day = "1",
doi = "10.1186/s13063-015-0843-6",
language = "English",
volume = "16",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

}

TY - JOUR

T1 - 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)?

T2 - Study protocol for a randomized controlled trial

AU - Witham, Miles D

AU - Band, Margaret M

AU - Littleford, Roberta C

AU - Avenell, Alison

AU - Soiza, Roy L

AU - McMurdo, Marion E T

AU - Sumukadas, Deepa

AU - Ogston, Simon A

AU - Lamb, Edmund J

AU - Hampson, Geeta

AU - MacNamee, Paul

AU - BiCARB Study Group

N1 - Date of acceptance: 01/07/2015 © 2015 Witham et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Acknowledgements UK NIHR HTA grant 10/71/01. We acknowledge the financial support of NHS Research Scotland in conducting this trial.

PY - 2015/8/1

Y1 - 2015/8/1

N2 - 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 UK centres. Male and female patients aged 60 years and over with estimated glomerular filtration rate of <30 mL/min/1.73m2, 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.

AB - 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 UK centres. Male and female patients aged 60 years and over with estimated glomerular filtration rate of <30 mL/min/1.73m2, 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.

KW - older

KW - bicarbonate

KW - metabolic acidosis

KW - physical function

KW - quality of life

KW - chronic kidney disease

KW - randomised controlled trial

U2 - 10.1186/s13063-015-0843-6

DO - 10.1186/s13063-015-0843-6

M3 - Article

VL - 16

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 326

ER -