Sodium citrate versus sodium bicarbonate for metabolic acidosis in patients with chronic kidney disease: A randomized controlled trial
Metabolic acidosis (MA) is frequently associated with chronic kidney disease (CKD) progression. Our aim was to compare the effect of oral sodium citrate (SC) with that of oral sodium bicarbonate (SB) on renal function and serum bicarbonate correction, as well as to evaluate their safety profile in p...
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| Veröffentlicht in: | Medicine (Baltimore) 2024-03, Vol.103 (10), p.e37475-e37475 |
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| creator | Sorohan, Bogdan Marian Obrișcă, Bogdan Jurubiță, Roxana Lupușoru, Gabriela Achim, Camelia Andronesi, Andreea Frățilă, Georgiana Berechet, Andreea Micu, Georgia Ismail, Gener |
| description | Metabolic acidosis (MA) is frequently associated with chronic kidney disease (CKD) progression. Our aim was to compare the effect of oral sodium citrate (SC) with that of oral sodium bicarbonate (SB) on renal function and serum bicarbonate correction, as well as to evaluate their safety profile in patients with MA of CKD.
We conducted a prospective, single-center, randomized 1:1, parallel, controlled, unblinded clinical trial of 124 patients with MA and CKD stages 3b and 4. The primary outcome was the mean change in estimated glomerular filtration rate (eGFR). The secondary outcomes were mean change in serum bicarbonate level, eGFR decrease by 30%, eGFR decrease by 50%, dialysis, death or prolonged hospitalization, and a combined endpoint.
No significant difference was found between the groups in terms of mean eGFR change [adjusted mean difference = -0.99 mL/min/1.73 m2 (95% CI: -2.51 to 0.93, P = .20)]. We observed a mean serum bicarbonate change of 6.15 mmol/L [(95% CI: 5.55-6.74), P |
| doi_str_mv | 10.1097/MD.0000000000037475 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10919529</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2954775591</sourcerecordid><originalsourceid>FETCH-LOGICAL-c356t-39d76111fc87753ab312a95f81c33186b8cc5ca4094bdf4f98a118e8ae3c21ba3</originalsourceid><addsrcrecordid>eNpdUctu1TAQtRCI3ha-AAl5ySbFju04ZoOqthSkViyAtTWxHe5AYl9sp6h8AN9NqlvKYzYzmnPmzNEMIc84O-bM6JdXZ8fsTwgttXpANlyJrlGmkw_JhrFWNdpoeUAOS_nCGBe6lY_Jgeil0krLDfn5IXlcZuqwZqiBXodclkLLvjuggzykeIuMKdM5VBjShI6CQ58KFoqR7qBiiLXQ71i31G1ziivjK_oYbqjHEqCEV_SEZog-zfgjeOpSrDlN01rWjDA9IY9GmEp4epePyKc35x9P3zaX7y_enZ5cNk6orjbCeN1xzkfXa60EDIK3YNTYcycE77uhd045kMzIwY9yND1w3ocegnAtH0Ackdd73d0yzMG71XaGye4yzpBvbAK0_yIRt_ZzurbrxblRrVkVXtwp5PRtCaXaGYsL0wQxpKXY1ii5elOGr1Sxp7qcSslhvN_D2a2gtldn9v8XrlPP_7Z4P_P7Z-IXRf6bAg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2954775591</pqid></control><display><type>article</type><title>Sodium citrate versus sodium bicarbonate for metabolic acidosis in patients with chronic kidney disease: A randomized controlled trial</title><source>DOAJ Directory of Open Access Journals</source><source>Wolters Kluwer Open Health</source><source>IngentaConnect Free/Open Access Journals</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Sorohan, Bogdan Marian ; Obrișcă, Bogdan ; Jurubiță, Roxana ; Lupușoru, Gabriela ; Achim, Camelia ; Andronesi, Andreea ; Frățilă, Georgiana ; Berechet, Andreea ; Micu, Georgia ; Ismail, Gener</creator><creatorcontrib>Sorohan, Bogdan Marian ; Obrișcă, Bogdan ; Jurubiță, Roxana ; Lupușoru, Gabriela ; Achim, Camelia ; Andronesi, Andreea ; Frățilă, Georgiana ; Berechet, Andreea ; Micu, Georgia ; Ismail, Gener</creatorcontrib><description>Metabolic acidosis (MA) is frequently associated with chronic kidney disease (CKD) progression. Our aim was to compare the effect of oral sodium citrate (SC) with that of oral sodium bicarbonate (SB) on renal function and serum bicarbonate correction, as well as to evaluate their safety profile in patients with MA of CKD.
We conducted a prospective, single-center, randomized 1:1, parallel, controlled, unblinded clinical trial of 124 patients with MA and CKD stages 3b and 4. The primary outcome was the mean change in estimated glomerular filtration rate (eGFR). The secondary outcomes were mean change in serum bicarbonate level, eGFR decrease by 30%, eGFR decrease by 50%, dialysis, death or prolonged hospitalization, and a combined endpoint.
No significant difference was found between the groups in terms of mean eGFR change [adjusted mean difference = -0.99 mL/min/1.73 m2 (95% CI: -2.51 to 0.93, P = .20)]. We observed a mean serum bicarbonate change of 6.15 mmol/L [(95% CI: 5.55-6.74), P < .001] in the SC group and of 6.19 mmol/L [(95% CI: 5.54-6.83), P < .001] in the SB group, but no significant difference between the 2 groups [adjusted mean difference = 0.31 mmol/L (-0.22 to 0.85), P = .25]. Cox proportional hazard analysis showed similar risks regarding eGFR decrease by 30% (P = .77), eGFR decrease by 50% (P = .50), dialysis (P = .85), death or prolonged hospitalization (P = .29), and combined endpoint (P = .57). Study drug discontinuation due to adverse events was significantly more common in the SB group (17.7% vs 4.8%, P = .02).
SC and SB have a similar effect on kidney function decline, both improve serum bicarbonate level, but SB is associated with higher rates of medication discontinuation due to adverse events.</description><identifier>ISSN: 0025-7974</identifier><identifier>EISSN: 1536-5964</identifier><identifier>DOI: 10.1097/MD.0000000000037475</identifier><identifier>PMID: 38457574</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins</publisher><subject>Clinical Trial/Experimental Study</subject><ispartof>Medicine (Baltimore), 2024-03, Vol.103 (10), p.e37475-e37475</ispartof><rights>Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.</rights><rights>Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c356t-39d76111fc87753ab312a95f81c33186b8cc5ca4094bdf4f98a118e8ae3c21ba3</cites><orcidid>0000-0003-3574-4635</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10919529/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10919529/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38457574$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sorohan, Bogdan Marian</creatorcontrib><creatorcontrib>Obrișcă, Bogdan</creatorcontrib><creatorcontrib>Jurubiță, Roxana</creatorcontrib><creatorcontrib>Lupușoru, Gabriela</creatorcontrib><creatorcontrib>Achim, Camelia</creatorcontrib><creatorcontrib>Andronesi, Andreea</creatorcontrib><creatorcontrib>Frățilă, Georgiana</creatorcontrib><creatorcontrib>Berechet, Andreea</creatorcontrib><creatorcontrib>Micu, Georgia</creatorcontrib><creatorcontrib>Ismail, Gener</creatorcontrib><title>Sodium citrate versus sodium bicarbonate for metabolic acidosis in patients with chronic kidney disease: A randomized controlled trial</title><title>Medicine (Baltimore)</title><addtitle>Medicine (Baltimore)</addtitle><description>Metabolic acidosis (MA) is frequently associated with chronic kidney disease (CKD) progression. Our aim was to compare the effect of oral sodium citrate (SC) with that of oral sodium bicarbonate (SB) on renal function and serum bicarbonate correction, as well as to evaluate their safety profile in patients with MA of CKD.
We conducted a prospective, single-center, randomized 1:1, parallel, controlled, unblinded clinical trial of 124 patients with MA and CKD stages 3b and 4. The primary outcome was the mean change in estimated glomerular filtration rate (eGFR). The secondary outcomes were mean change in serum bicarbonate level, eGFR decrease by 30%, eGFR decrease by 50%, dialysis, death or prolonged hospitalization, and a combined endpoint.
No significant difference was found between the groups in terms of mean eGFR change [adjusted mean difference = -0.99 mL/min/1.73 m2 (95% CI: -2.51 to 0.93, P = .20)]. We observed a mean serum bicarbonate change of 6.15 mmol/L [(95% CI: 5.55-6.74), P < .001] in the SC group and of 6.19 mmol/L [(95% CI: 5.54-6.83), P < .001] in the SB group, but no significant difference between the 2 groups [adjusted mean difference = 0.31 mmol/L (-0.22 to 0.85), P = .25]. Cox proportional hazard analysis showed similar risks regarding eGFR decrease by 30% (P = .77), eGFR decrease by 50% (P = .50), dialysis (P = .85), death or prolonged hospitalization (P = .29), and combined endpoint (P = .57). Study drug discontinuation due to adverse events was significantly more common in the SB group (17.7% vs 4.8%, P = .02).
SC and SB have a similar effect on kidney function decline, both improve serum bicarbonate level, but SB is associated with higher rates of medication discontinuation due to adverse events.</description><subject>Clinical Trial/Experimental Study</subject><issn>0025-7974</issn><issn>1536-5964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpdUctu1TAQtRCI3ha-AAl5ySbFju04ZoOqthSkViyAtTWxHe5AYl9sp6h8AN9NqlvKYzYzmnPmzNEMIc84O-bM6JdXZ8fsTwgttXpANlyJrlGmkw_JhrFWNdpoeUAOS_nCGBe6lY_Jgeil0krLDfn5IXlcZuqwZqiBXodclkLLvjuggzykeIuMKdM5VBjShI6CQ58KFoqR7qBiiLXQ71i31G1ziivjK_oYbqjHEqCEV_SEZog-zfgjeOpSrDlN01rWjDA9IY9GmEp4epePyKc35x9P3zaX7y_enZ5cNk6orjbCeN1xzkfXa60EDIK3YNTYcycE77uhd045kMzIwY9yND1w3ocegnAtH0Ackdd73d0yzMG71XaGye4yzpBvbAK0_yIRt_ZzurbrxblRrVkVXtwp5PRtCaXaGYsL0wQxpKXY1ii5elOGr1Sxp7qcSslhvN_D2a2gtldn9v8XrlPP_7Z4P_P7Z-IXRf6bAg</recordid><startdate>20240308</startdate><enddate>20240308</enddate><creator>Sorohan, Bogdan Marian</creator><creator>Obrișcă, Bogdan</creator><creator>Jurubiță, Roxana</creator><creator>Lupușoru, Gabriela</creator><creator>Achim, Camelia</creator><creator>Andronesi, Andreea</creator><creator>Frățilă, Georgiana</creator><creator>Berechet, Andreea</creator><creator>Micu, Georgia</creator><creator>Ismail, Gener</creator><general>Lippincott Williams & Wilkins</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-3574-4635</orcidid></search><sort><creationdate>20240308</creationdate><title>Sodium citrate versus sodium bicarbonate for metabolic acidosis in patients with chronic kidney disease: A randomized controlled trial</title><author>Sorohan, Bogdan Marian ; Obrișcă, Bogdan ; Jurubiță, Roxana ; Lupușoru, Gabriela ; Achim, Camelia ; Andronesi, Andreea ; Frățilă, Georgiana ; Berechet, Andreea ; Micu, Georgia ; Ismail, Gener</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-39d76111fc87753ab312a95f81c33186b8cc5ca4094bdf4f98a118e8ae3c21ba3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Clinical Trial/Experimental Study</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sorohan, Bogdan Marian</creatorcontrib><creatorcontrib>Obrișcă, Bogdan</creatorcontrib><creatorcontrib>Jurubiță, Roxana</creatorcontrib><creatorcontrib>Lupușoru, Gabriela</creatorcontrib><creatorcontrib>Achim, Camelia</creatorcontrib><creatorcontrib>Andronesi, Andreea</creatorcontrib><creatorcontrib>Frățilă, Georgiana</creatorcontrib><creatorcontrib>Berechet, Andreea</creatorcontrib><creatorcontrib>Micu, Georgia</creatorcontrib><creatorcontrib>Ismail, Gener</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Medicine (Baltimore)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sorohan, Bogdan Marian</au><au>Obrișcă, Bogdan</au><au>Jurubiță, Roxana</au><au>Lupușoru, Gabriela</au><au>Achim, Camelia</au><au>Andronesi, Andreea</au><au>Frățilă, Georgiana</au><au>Berechet, Andreea</au><au>Micu, Georgia</au><au>Ismail, Gener</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sodium citrate versus sodium bicarbonate for metabolic acidosis in patients with chronic kidney disease: A randomized controlled trial</atitle><jtitle>Medicine (Baltimore)</jtitle><addtitle>Medicine (Baltimore)</addtitle><date>2024-03-08</date><risdate>2024</risdate><volume>103</volume><issue>10</issue><spage>e37475</spage><epage>e37475</epage><pages>e37475-e37475</pages><issn>0025-7974</issn><eissn>1536-5964</eissn><abstract>Metabolic acidosis (MA) is frequently associated with chronic kidney disease (CKD) progression. Our aim was to compare the effect of oral sodium citrate (SC) with that of oral sodium bicarbonate (SB) on renal function and serum bicarbonate correction, as well as to evaluate their safety profile in patients with MA of CKD.
We conducted a prospective, single-center, randomized 1:1, parallel, controlled, unblinded clinical trial of 124 patients with MA and CKD stages 3b and 4. The primary outcome was the mean change in estimated glomerular filtration rate (eGFR). The secondary outcomes were mean change in serum bicarbonate level, eGFR decrease by 30%, eGFR decrease by 50%, dialysis, death or prolonged hospitalization, and a combined endpoint.
No significant difference was found between the groups in terms of mean eGFR change [adjusted mean difference = -0.99 mL/min/1.73 m2 (95% CI: -2.51 to 0.93, P = .20)]. We observed a mean serum bicarbonate change of 6.15 mmol/L [(95% CI: 5.55-6.74), P < .001] in the SC group and of 6.19 mmol/L [(95% CI: 5.54-6.83), P < .001] in the SB group, but no significant difference between the 2 groups [adjusted mean difference = 0.31 mmol/L (-0.22 to 0.85), P = .25]. Cox proportional hazard analysis showed similar risks regarding eGFR decrease by 30% (P = .77), eGFR decrease by 50% (P = .50), dialysis (P = .85), death or prolonged hospitalization (P = .29), and combined endpoint (P = .57). Study drug discontinuation due to adverse events was significantly more common in the SB group (17.7% vs 4.8%, P = .02).
SC and SB have a similar effect on kidney function decline, both improve serum bicarbonate level, but SB is associated with higher rates of medication discontinuation due to adverse events.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins</pub><pmid>38457574</pmid><doi>10.1097/MD.0000000000037475</doi><orcidid>https://orcid.org/0000-0003-3574-4635</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Clinical Trial/Experimental Study |
| title | Sodium citrate versus sodium bicarbonate for metabolic acidosis in patients with chronic kidney disease: A randomized controlled trial |
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