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Clinical and cost-effectiveness of oral sodium bicarbonate therapy for older patients with chronic kidney disease and low-grade acidosis (BiCARB): a pragmatic randomised, double-blind, placebo-controlled trial
Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbona...
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| Published in: | BMC medicine 2020-04, Vol.18 (1), p.91-91, Article 91 |
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| creator | Duncan, Neill Sumukadas, Deepa Avenell, Alison Rauchhaus, Petra Mishra, Biswa Stevens, Paul E Warwick, Graham Balasubramaniam, Gowrie Hampson, Geeta Band, Margaret Lambie, Stewart Witham, Miles D Chong, Huey Yi Wilkie, Martin Tse, Wai Ahmed, Aimun McNamee, Paul Lamb, Edmund J Plews, Deirdre Kirk, Adam Bhatnagar, Deepak Winnett, Georgia Kennedy, Gwen Mitra, Sandip Donnan, Peter T Kalra, Philip A Soiza, Roy L Chan, Anthony Littleford, Roberta Basnayake, Kolitha Hu, May Khei Nicholas, Johann Almond, Michael K |
| description | Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbonate concentrations |
| doi_str_mv | 10.1186/s12916-020-01542-9 |
| format | article |
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Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m
, not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. Participants received oral sodium bicarbonate (up to 3 g/day) or matching placebo given for up to 2 years, randomised in a 1:1 ratio. The primary outcome was between-group difference in the Short Physical Performance Battery (SPPB) at 12 months, adjusted for baseline values, analysed by intention to treat. Secondary outcomes included generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained.
We randomised 300 participants between May 2013 and February 2017, mean age 74 years, 86 (29%) female. At 12 months, 116/152 (76%) participants allocated to bicarbonate and 104/148 (70%) allocated to placebo were assessed; primary outcome data were available for 187 participants. We found no significant treatment effect for the SPPB: bicarbonate arm 8.3 (SD 2.5) points, placebo arm 8.8 (SD 2.2) and adjusted treatment effect - 0.4 (95% CI - 0.9 to 0.1, p = 0.15). We found no significant treatment effect for glomerular filtration rate (0.6 mL/min/1.73 m
, 95% CI - 0.8 to 2.0, p = 0.39). The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses. Adverse events were more frequent in those randomised to bicarbonate (457 versus 400).
Oral sodium bicarbonate did not improve physical function or renal function, increased adverse events and is unlikely to be cost-effective for use by the UK NHS for this patient group.
European Clinical Trials Database (2011-005271-16) and ISRCTN09486651; registered 17 February 2012.</description><identifier>ISSN: 1741-7015</identifier><identifier>EISSN: 1741-7015</identifier><identifier>DOI: 10.1186/s12916-020-01542-9</identifier><identifier>PMID: 32268897</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Acidosis ; Acidosis - drug therapy ; Age ; Aged ; Anthropometry ; Batteries ; Bicarbonates - blood ; Biomarkers - blood ; Blood pressure ; Bone density ; Carbonates ; Chronic kidney failure ; Clinical medicine ; Clinical trials ; Cost-Benefit Analysis - methods ; Dialysis ; Double-Blind Method ; Double-blind studies ; Elderly patients ; Female ; Glomerular filtration rate ; Health care costs ; Health services ; Humans ; Hypertension ; Kidney diseases ; Kidneys ; Male ; Metabolic acidosis ; Metabolism ; Nephrology ; Older people ; Patients ; Phosphatase ; Quality of life ; Quality of Life - psychology ; Randomised controlled trial ; Randomization ; Renal function ; Renal insufficiency, chronic ; Renal Insufficiency, Chronic - drug therapy ; Sensitivity analysis ; Sodium ; Sodium bicarbonate ; Sodium Bicarbonate - administration & dosage ; Sodium Bicarbonate - economics</subject><ispartof>BMC medicine, 2020-04, Vol.18 (1), p.91-91, Article 91</ispartof><rights>COPYRIGHT 2020 BioMed Central Ltd.</rights><rights>2020. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c664t-95781d6333839033b13146d6efed475225ee68ce3113015d06185ba0fd747e6c3</citedby><cites>FETCH-LOGICAL-c664t-95781d6333839033b13146d6efed475225ee68ce3113015d06185ba0fd747e6c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7144058/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2391290804?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,25731,27901,27902,36989,36990,44566,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32268897$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Duncan, Neill</creatorcontrib><creatorcontrib>Sumukadas, Deepa</creatorcontrib><creatorcontrib>Avenell, Alison</creatorcontrib><creatorcontrib>Rauchhaus, Petra</creatorcontrib><creatorcontrib>Mishra, Biswa</creatorcontrib><creatorcontrib>Stevens, Paul E</creatorcontrib><creatorcontrib>Warwick, Graham</creatorcontrib><creatorcontrib>Balasubramaniam, Gowrie</creatorcontrib><creatorcontrib>Hampson, Geeta</creatorcontrib><creatorcontrib>Band, Margaret</creatorcontrib><creatorcontrib>Lambie, Stewart</creatorcontrib><creatorcontrib>Witham, Miles D</creatorcontrib><creatorcontrib>Chong, Huey Yi</creatorcontrib><creatorcontrib>Wilkie, Martin</creatorcontrib><creatorcontrib>Tse, Wai</creatorcontrib><creatorcontrib>Ahmed, Aimun</creatorcontrib><creatorcontrib>McNamee, Paul</creatorcontrib><creatorcontrib>Lamb, Edmund J</creatorcontrib><creatorcontrib>Plews, Deirdre</creatorcontrib><creatorcontrib>Kirk, Adam</creatorcontrib><creatorcontrib>Bhatnagar, Deepak</creatorcontrib><creatorcontrib>Winnett, Georgia</creatorcontrib><creatorcontrib>Kennedy, Gwen</creatorcontrib><creatorcontrib>Mitra, Sandip</creatorcontrib><creatorcontrib>Donnan, Peter T</creatorcontrib><creatorcontrib>Kalra, Philip A</creatorcontrib><creatorcontrib>Soiza, Roy L</creatorcontrib><creatorcontrib>Chan, Anthony</creatorcontrib><creatorcontrib>Littleford, Roberta</creatorcontrib><creatorcontrib>Basnayake, Kolitha</creatorcontrib><creatorcontrib>Hu, May Khei</creatorcontrib><creatorcontrib>Nicholas, Johann</creatorcontrib><creatorcontrib>Almond, Michael K</creatorcontrib><creatorcontrib>BiCARB study group</creatorcontrib><creatorcontrib>The BiCARB study group</creatorcontrib><title>Clinical and cost-effectiveness of oral sodium bicarbonate therapy for older patients with chronic kidney disease and low-grade acidosis (BiCARB): a pragmatic randomised, double-blind, placebo-controlled trial</title><title>BMC medicine</title><addtitle>BMC Med</addtitle><description>Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbonate concentrations < 22 mmol/L.
Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m
, not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. Participants received oral sodium bicarbonate (up to 3 g/day) or matching placebo given for up to 2 years, randomised in a 1:1 ratio. The primary outcome was between-group difference in the Short Physical Performance Battery (SPPB) at 12 months, adjusted for baseline values, analysed by intention to treat. Secondary outcomes included generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained.
We randomised 300 participants between May 2013 and February 2017, mean age 74 years, 86 (29%) female. At 12 months, 116/152 (76%) participants allocated to bicarbonate and 104/148 (70%) allocated to placebo were assessed; primary outcome data were available for 187 participants. We found no significant treatment effect for the SPPB: bicarbonate arm 8.3 (SD 2.5) points, placebo arm 8.8 (SD 2.2) and adjusted treatment effect - 0.4 (95% CI - 0.9 to 0.1, p = 0.15). We found no significant treatment effect for glomerular filtration rate (0.6 mL/min/1.73 m
, 95% CI - 0.8 to 2.0, p = 0.39). The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses. Adverse events were more frequent in those randomised to bicarbonate (457 versus 400).
Oral sodium bicarbonate did not improve physical function or renal function, increased adverse events and is unlikely to be cost-effective for use by the UK NHS for this patient group.
European Clinical Trials Database (2011-005271-16) and ISRCTN09486651; registered 17 February 2012.</description><subject>Acidosis</subject><subject>Acidosis - drug therapy</subject><subject>Age</subject><subject>Aged</subject><subject>Anthropometry</subject><subject>Batteries</subject><subject>Bicarbonates - blood</subject><subject>Biomarkers - blood</subject><subject>Blood pressure</subject><subject>Bone density</subject><subject>Carbonates</subject><subject>Chronic kidney failure</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Cost-Benefit Analysis - methods</subject><subject>Dialysis</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Elderly patients</subject><subject>Female</subject><subject>Glomerular filtration rate</subject><subject>Health care costs</subject><subject>Health services</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Kidney diseases</subject><subject>Kidneys</subject><subject>Male</subject><subject>Metabolic acidosis</subject><subject>Metabolism</subject><subject>Nephrology</subject><subject>Older people</subject><subject>Patients</subject><subject>Phosphatase</subject><subject>Quality of life</subject><subject>Quality of Life - psychology</subject><subject>Randomised controlled trial</subject><subject>Randomization</subject><subject>Renal function</subject><subject>Renal insufficiency, chronic</subject><subject>Renal Insufficiency, Chronic - drug therapy</subject><subject>Sensitivity analysis</subject><subject>Sodium</subject><subject>Sodium bicarbonate</subject><subject>Sodium Bicarbonate - administration & dosage</subject><subject>Sodium Bicarbonate - economics</subject><issn>1741-7015</issn><issn>1741-7015</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNptkl1rFDEUhgdRbK3-AS8kIEgFp-ZjJsl4IbSLH4WCIHodMsmZ3dTsZE1mWvoz_UeedmvtisxF5iTPeZO8eavqOaNHjGn5tjDeMVlTTmvK2obX3YNqn6mG1Qrrh_f-96onpZxTylulmsfVnuBcat2p_erXIoYxOBuJHT1xqUw1DAO4KVzACKWQNJCUcbkkH-Y16ZHNfRrtBGRaQbabKzKkTFL0kMnGTgHGqZDLMK2IW-WE2uRH8CNcER8K2AI3G8V0WS-z9Vi54FMJhRyehMXx15PX74glm2yXa9RyJCOd1tjp3xCf5j5C3eOJsdpE66BPtUvjlFOM4MmUg41Pq0eDjQWe3Y4H1fePH74tPtdnXz6dLo7PaidlM9VdqzTzUgihRUeF6JlgjfQSBvCNajlvAaR2IBgT6KCnkum2t3TwqlEgnTioTre6Ptlzs8lhbfOVSTaYm4mUl8ZmvEIEI_rOuoGrgXPfaOFtD7aTAri2HLSyqPV-q7WZ-zV4hx6i5zuiuytjWJllujCKNQ1tNQoc3grk9HOGMhn0zEGMdoQ0F8OF1pRS2VyjL_9Bz9OcR7QKqQ4jRTVt_lJLixcI45BwX3ctao4lV0JQJSlSR_-h8POwDvgwMASc32l4da9hBTZOq5LiPIU0ll2Qb0GXUykZhjszGDXX6Tfb9BtMv7lJv-mw6cV9G-9a_sRd_AasBwFV</recordid><startdate>20200409</startdate><enddate>20200409</enddate><creator>Duncan, Neill</creator><creator>Sumukadas, Deepa</creator><creator>Avenell, Alison</creator><creator>Rauchhaus, Petra</creator><creator>Mishra, Biswa</creator><creator>Stevens, Paul E</creator><creator>Warwick, Graham</creator><creator>Balasubramaniam, Gowrie</creator><creator>Hampson, Geeta</creator><creator>Band, Margaret</creator><creator>Lambie, Stewart</creator><creator>Witham, Miles D</creator><creator>Chong, Huey Yi</creator><creator>Wilkie, Martin</creator><creator>Tse, Wai</creator><creator>Ahmed, Aimun</creator><creator>McNamee, Paul</creator><creator>Lamb, Edmund J</creator><creator>Plews, Deirdre</creator><creator>Kirk, Adam</creator><creator>Bhatnagar, Deepak</creator><creator>Winnett, Georgia</creator><creator>Kennedy, Gwen</creator><creator>Mitra, Sandip</creator><creator>Donnan, Peter T</creator><creator>Kalra, Philip A</creator><creator>Soiza, Roy L</creator><creator>Chan, Anthony</creator><creator>Littleford, Roberta</creator><creator>Basnayake, Kolitha</creator><creator>Hu, May Khei</creator><creator>Nicholas, Johann</creator><creator>Almond, Michael K</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><general>BMC</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20200409</creationdate><title>Clinical and cost-effectiveness of oral sodium bicarbonate therapy for older patients with chronic kidney disease and low-grade acidosis (BiCARB): a pragmatic randomised, double-blind, placebo-controlled trial</title><author>Duncan, Neill ; Sumukadas, Deepa ; Avenell, Alison ; Rauchhaus, Petra ; Mishra, Biswa ; Stevens, Paul E ; Warwick, Graham ; Balasubramaniam, Gowrie ; Hampson, Geeta ; Band, Margaret ; Lambie, Stewart ; Witham, Miles D ; Chong, Huey Yi ; Wilkie, Martin ; Tse, Wai ; Ahmed, Aimun ; McNamee, Paul ; Lamb, Edmund J ; Plews, Deirdre ; Kirk, Adam ; Bhatnagar, Deepak ; Winnett, Georgia ; Kennedy, Gwen ; Mitra, Sandip ; Donnan, Peter T ; Kalra, Philip A ; Soiza, Roy L ; Chan, Anthony ; Littleford, Roberta ; Basnayake, Kolitha ; Hu, May Khei ; Nicholas, Johann ; Almond, Michael K</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c664t-95781d6333839033b13146d6efed475225ee68ce3113015d06185ba0fd747e6c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Acidosis</topic><topic>Acidosis - drug therapy</topic><topic>Age</topic><topic>Aged</topic><topic>Anthropometry</topic><topic>Batteries</topic><topic>Bicarbonates - blood</topic><topic>Biomarkers - blood</topic><topic>Blood pressure</topic><topic>Bone density</topic><topic>Carbonates</topic><topic>Chronic kidney failure</topic><topic>Clinical medicine</topic><topic>Clinical trials</topic><topic>Cost-Benefit Analysis - methods</topic><topic>Dialysis</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Elderly patients</topic><topic>Female</topic><topic>Glomerular filtration rate</topic><topic>Health care costs</topic><topic>Health services</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Kidney diseases</topic><topic>Kidneys</topic><topic>Male</topic><topic>Metabolic acidosis</topic><topic>Metabolism</topic><topic>Nephrology</topic><topic>Older people</topic><topic>Patients</topic><topic>Phosphatase</topic><topic>Quality of life</topic><topic>Quality of Life - psychology</topic><topic>Randomised controlled trial</topic><topic>Randomization</topic><topic>Renal function</topic><topic>Renal insufficiency, chronic</topic><topic>Renal Insufficiency, Chronic - drug therapy</topic><topic>Sensitivity analysis</topic><topic>Sodium</topic><topic>Sodium bicarbonate</topic><topic>Sodium Bicarbonate - administration & dosage</topic><topic>Sodium Bicarbonate - economics</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Duncan, Neill</creatorcontrib><creatorcontrib>Sumukadas, Deepa</creatorcontrib><creatorcontrib>Avenell, Alison</creatorcontrib><creatorcontrib>Rauchhaus, Petra</creatorcontrib><creatorcontrib>Mishra, Biswa</creatorcontrib><creatorcontrib>Stevens, Paul E</creatorcontrib><creatorcontrib>Warwick, Graham</creatorcontrib><creatorcontrib>Balasubramaniam, Gowrie</creatorcontrib><creatorcontrib>Hampson, Geeta</creatorcontrib><creatorcontrib>Band, Margaret</creatorcontrib><creatorcontrib>Lambie, Stewart</creatorcontrib><creatorcontrib>Witham, Miles D</creatorcontrib><creatorcontrib>Chong, Huey Yi</creatorcontrib><creatorcontrib>Wilkie, Martin</creatorcontrib><creatorcontrib>Tse, Wai</creatorcontrib><creatorcontrib>Ahmed, Aimun</creatorcontrib><creatorcontrib>McNamee, Paul</creatorcontrib><creatorcontrib>Lamb, Edmund J</creatorcontrib><creatorcontrib>Plews, Deirdre</creatorcontrib><creatorcontrib>Kirk, Adam</creatorcontrib><creatorcontrib>Bhatnagar, Deepak</creatorcontrib><creatorcontrib>Winnett, Georgia</creatorcontrib><creatorcontrib>Kennedy, Gwen</creatorcontrib><creatorcontrib>Mitra, Sandip</creatorcontrib><creatorcontrib>Donnan, Peter T</creatorcontrib><creatorcontrib>Kalra, Philip A</creatorcontrib><creatorcontrib>Soiza, Roy L</creatorcontrib><creatorcontrib>Chan, Anthony</creatorcontrib><creatorcontrib>Littleford, Roberta</creatorcontrib><creatorcontrib>Basnayake, Kolitha</creatorcontrib><creatorcontrib>Hu, May Khei</creatorcontrib><creatorcontrib>Nicholas, Johann</creatorcontrib><creatorcontrib>Almond, Michael K</creatorcontrib><creatorcontrib>BiCARB study group</creatorcontrib><creatorcontrib>The BiCARB study group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>BMC medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Duncan, Neill</au><au>Sumukadas, Deepa</au><au>Avenell, Alison</au><au>Rauchhaus, Petra</au><au>Mishra, Biswa</au><au>Stevens, Paul E</au><au>Warwick, Graham</au><au>Balasubramaniam, Gowrie</au><au>Hampson, Geeta</au><au>Band, Margaret</au><au>Lambie, Stewart</au><au>Witham, Miles D</au><au>Chong, Huey Yi</au><au>Wilkie, Martin</au><au>Tse, Wai</au><au>Ahmed, Aimun</au><au>McNamee, Paul</au><au>Lamb, Edmund J</au><au>Plews, Deirdre</au><au>Kirk, Adam</au><au>Bhatnagar, Deepak</au><au>Winnett, Georgia</au><au>Kennedy, Gwen</au><au>Mitra, Sandip</au><au>Donnan, Peter T</au><au>Kalra, Philip A</au><au>Soiza, Roy L</au><au>Chan, Anthony</au><au>Littleford, Roberta</au><au>Basnayake, Kolitha</au><au>Hu, May Khei</au><au>Nicholas, Johann</au><au>Almond, Michael K</au><aucorp>BiCARB study group</aucorp><aucorp>The BiCARB study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical and cost-effectiveness of oral sodium bicarbonate therapy for older patients with chronic kidney disease and low-grade acidosis (BiCARB): a pragmatic randomised, double-blind, placebo-controlled trial</atitle><jtitle>BMC medicine</jtitle><addtitle>BMC Med</addtitle><date>2020-04-09</date><risdate>2020</risdate><volume>18</volume><issue>1</issue><spage>91</spage><epage>91</epage><pages>91-91</pages><artnum>91</artnum><issn>1741-7015</issn><eissn>1741-7015</eissn><abstract>Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbonate concentrations < 22 mmol/L.
Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m
, not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. Participants received oral sodium bicarbonate (up to 3 g/day) or matching placebo given for up to 2 years, randomised in a 1:1 ratio. The primary outcome was between-group difference in the Short Physical Performance Battery (SPPB) at 12 months, adjusted for baseline values, analysed by intention to treat. Secondary outcomes included generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained.
We randomised 300 participants between May 2013 and February 2017, mean age 74 years, 86 (29%) female. At 12 months, 116/152 (76%) participants allocated to bicarbonate and 104/148 (70%) allocated to placebo were assessed; primary outcome data were available for 187 participants. We found no significant treatment effect for the SPPB: bicarbonate arm 8.3 (SD 2.5) points, placebo arm 8.8 (SD 2.2) and adjusted treatment effect - 0.4 (95% CI - 0.9 to 0.1, p = 0.15). We found no significant treatment effect for glomerular filtration rate (0.6 mL/min/1.73 m
, 95% CI - 0.8 to 2.0, p = 0.39). The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses. Adverse events were more frequent in those randomised to bicarbonate (457 versus 400).
Oral sodium bicarbonate did not improve physical function or renal function, increased adverse events and is unlikely to be cost-effective for use by the UK NHS for this patient group.
European Clinical Trials Database (2011-005271-16) and ISRCTN09486651; registered 17 February 2012.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>32268897</pmid><doi>10.1186/s12916-020-01542-9</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1741-7015 |
| ispartof | BMC medicine, 2020-04, Vol.18 (1), p.91-91, Article 91 |
| issn | 1741-7015 1741-7015 |
| language | eng |
| recordid | cdi_doaj_primary_oai_doaj_org_article_3b9acf27f22d483dabea963e28a2e87a |
| source | Publicly Available Content Database; PubMed Central |
| subjects | Acidosis Acidosis - drug therapy Age Aged Anthropometry Batteries Bicarbonates - blood Biomarkers - blood Blood pressure Bone density Carbonates Chronic kidney failure Clinical medicine Clinical trials Cost-Benefit Analysis - methods Dialysis Double-Blind Method Double-blind studies Elderly patients Female Glomerular filtration rate Health care costs Health services Humans Hypertension Kidney diseases Kidneys Male Metabolic acidosis Metabolism Nephrology Older people Patients Phosphatase Quality of life Quality of Life - psychology Randomised controlled trial Randomization Renal function Renal insufficiency, chronic Renal Insufficiency, Chronic - drug therapy Sensitivity analysis Sodium Sodium bicarbonate Sodium Bicarbonate - administration & dosage Sodium Bicarbonate - economics |
| title | Clinical and cost-effectiveness of oral sodium bicarbonate therapy for older patients with chronic kidney disease and low-grade acidosis (BiCARB): a pragmatic randomised, double-blind, placebo-controlled trial |
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