Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2017 |
| Outros Autores: | , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da UNIFESP |
| Texto Completo: | https://ccr.cicm.org.au/file/download-article?id=a342bc41-95e2-4486-99a9-2dac08baa423&settings=litnzgC1RAsiHS43rCo4xsUivqk8CYwid1mDE5xgeFg%3D https://repositorio.unifesp.br/handle/11600/54381 |
Resumo: | Background: The effectiveness and safety of balanced crystalloid fluids compared with saline (0.9% sodium chloride) as a fluid of choice in critically ill patients remain unclear. The effects of different fluid infusion rates on outcomes are also unknown. Objectives: To test the hypothesis that a balanced crystalloid solution, compared with saline, decreases 90-day all-cause mortality among critically ill patients |
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Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trialBackground: The effectiveness and safety of balanced crystalloid fluids compared with saline (0.9% sodium chloride) as a fluid of choice in critically ill patients remain unclear. The effects of different fluid infusion rates on outcomes are also unknown. Objectives: To test the hypothesis that a balanced crystalloid solution, compared with saline, decreases 90-day all-cause mortality among critically ill patientsand to test the hypothesis that slow, compared with rapid, infusion rate decreases 90-day mortality in this population of patients. Methods: The Balanced Solution versus Saline in Intensive Care Study (BaSICS) is a pragmatic, 2 x 2 factorial, randomised controlled trial. A total of 11 000 patients will be recruited from at least 100 Brazilian intensive care units. Patients will be randomised to receive Plasma-Lyte 148 or saline, and to rapid infusion (999 mL/h) or slow infusion (333 mL/h). Study fluids will be used for resuscitation episodes (at rapid or slow infusion rates), dilution of compatible medications and maintenance solutions. Patients, health care providers and investigators will be blinded to the solutions being tested. The rate of bolus infusion will not be blinded. Outcomes: The primary outcome is 90-day all-cause mortality. Secondary outcomes are: incidence of renal failure requiring renal replacement therapy within 90 days, incidence of acute kidney injury (Kidney Disease: Improving Global Outcomes stages 2 and 3), incidence of non-renal organ dysfunction assessed by Sepsis-related Organ Failure Assessment score at Days 3 and 7, and number of mechanical ventilation free days within the first 28 days after randomisation. Results and conclusions: The BaSICS trial will provide robust evidence on whether a balanced crystalloid, compared with saline, improves important patient outcomes in critically ill patients. BaSICS will also provide relevant information on whether bolus infusion rate affects outcomes in this population.Hosp Coracao, Res Inst HCor, Sao Paulo, BrazilHosp Sirio Libanes, Intens Care Unit, Sao Paulo, BrazilUniv Sao Paulo, Emergency Med Discipline, Sao Paulo, BrazilHosp Israelita Albert Einstein, Intens Care Unit, Sao Paulo, BrazilHosp Moinhos de Vento, Porto Alegre, RS, BrazilUniv Fed Sao Paulo, Hosp Sao Paulo, Anesthesiol Intens Care Unit, Intens Care, Sao Paulo, BrazilFac Med, Intens Care, Sao Jose Do Rio Preto, BrazilFac Med, Intens Care Div, Sao Jose Do Rio Preto, BrazilUniv Pittsburgh, Ctr Crit Care Nephrol, Pittsburgh, PA USAFed Univ Hlth Sci, Sch Med, Porto Alegre, RS, BrazilUniv Fed Sao Paulo, Hosp Sao Paulo, Anesthesiol Intens Care Unit, Intens Care, Sao Paulo, BrazilWeb of ScienceBaxter BrazilAustralasian Med Publ Co Ltd2020-07-13T11:53:05Z2020-07-13T11:53:05Z2017info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion175-182https://ccr.cicm.org.au/file/download-article?id=a342bc41-95e2-4486-99a9-2dac08baa423&settings=litnzgC1RAsiHS43rCo4xsUivqk8CYwid1mDE5xgeFg%3DCritical Care And Resuscitation. Pyrmont, v. 19, n. 2, p. 175-182, 2017.1441-2772https://repositorio.unifesp.br/handle/11600/54381WOS:000402584300013engCritical Care And ResuscitationPyrmontinfo:eu-repo/semantics/openAccessZampieri, Fernando G.Azevedo, Luciano C. P.Correa, Thiago D.Falavigna, MaiconMachado, Flavia R. [UNIFESP]de Assuncao, Murillo S. C.Lobo, Suzana M. A.Dourado, Leticia K.Berwanger, OtavioKellum, John A.Brandao, NiltonCavalcanti, Alexandre B.reponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP2021-10-05T21:59:10Zoai:repositorio.unifesp.br/:11600/54381Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestbiblioteca.csp@unifesp.bropendoar:34652021-10-05T21:59:10Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false |
| dc.title.none.fl_str_mv |
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial |
| title |
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial |
| spellingShingle |
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial Zampieri, Fernando G. |
| title_short |
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial |
| title_full |
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial |
| title_fullStr |
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial |
| title_full_unstemmed |
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial |
| title_sort |
Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial |
| author |
Zampieri, Fernando G. |
| author_facet |
Zampieri, Fernando G. Azevedo, Luciano C. P. Correa, Thiago D. Falavigna, Maicon Machado, Flavia R. [UNIFESP] de Assuncao, Murillo S. C. Lobo, Suzana M. A. Dourado, Leticia K. Berwanger, Otavio Kellum, John A. Brandao, Nilton Cavalcanti, Alexandre B. |
| author_role |
author |
| author2 |
Azevedo, Luciano C. P. Correa, Thiago D. Falavigna, Maicon Machado, Flavia R. [UNIFESP] de Assuncao, Murillo S. C. Lobo, Suzana M. A. Dourado, Leticia K. Berwanger, Otavio Kellum, John A. Brandao, Nilton Cavalcanti, Alexandre B. |
| author2_role |
author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Zampieri, Fernando G. Azevedo, Luciano C. P. Correa, Thiago D. Falavigna, Maicon Machado, Flavia R. [UNIFESP] de Assuncao, Murillo S. C. Lobo, Suzana M. A. Dourado, Leticia K. Berwanger, Otavio Kellum, John A. Brandao, Nilton Cavalcanti, Alexandre B. |
| description |
Background: The effectiveness and safety of balanced crystalloid fluids compared with saline (0.9% sodium chloride) as a fluid of choice in critically ill patients remain unclear. The effects of different fluid infusion rates on outcomes are also unknown. Objectives: To test the hypothesis that a balanced crystalloid solution, compared with saline, decreases 90-day all-cause mortality among critically ill patients |
| publishDate |
2017 |
| dc.date.none.fl_str_mv |
2017 2020-07-13T11:53:05Z 2020-07-13T11:53:05Z |
| dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
| dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
| format |
article |
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publishedVersion |
| dc.identifier.uri.fl_str_mv |
https://ccr.cicm.org.au/file/download-article?id=a342bc41-95e2-4486-99a9-2dac08baa423&settings=litnzgC1RAsiHS43rCo4xsUivqk8CYwid1mDE5xgeFg%3D Critical Care And Resuscitation. Pyrmont, v. 19, n. 2, p. 175-182, 2017. 1441-2772 https://repositorio.unifesp.br/handle/11600/54381 WOS:000402584300013 |
| url |
https://ccr.cicm.org.au/file/download-article?id=a342bc41-95e2-4486-99a9-2dac08baa423&settings=litnzgC1RAsiHS43rCo4xsUivqk8CYwid1mDE5xgeFg%3D https://repositorio.unifesp.br/handle/11600/54381 |
| identifier_str_mv |
Critical Care And Resuscitation. Pyrmont, v. 19, n. 2, p. 175-182, 2017. 1441-2772 WOS:000402584300013 |
| dc.language.iso.fl_str_mv |
eng |
| language |
eng |
| dc.relation.none.fl_str_mv |
Critical Care And Resuscitation |
| dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
| eu_rights_str_mv |
openAccess |
| dc.format.none.fl_str_mv |
175-182 |
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Pyrmont |
| dc.publisher.none.fl_str_mv |
Australasian Med Publ Co Ltd |
| publisher.none.fl_str_mv |
Australasian Med Publ Co Ltd |
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reponame:Repositório Institucional da UNIFESP instname:Universidade Federal de São Paulo (UNIFESP) instacron:UNIFESP |
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Universidade Federal de São Paulo (UNIFESP) |
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UNIFESP |
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UNIFESP |
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Repositório Institucional da UNIFESP |
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Repositório Institucional da UNIFESP |
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Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP) |
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biblioteca.csp@unifesp.br |
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1814268447511543808 |