Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial

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dc.citation.issue2
dc.citation.volume19
dc.contributor.authorZampieri, Fernando G.
dc.contributor.authorAzevedo, Luciano C. P.
dc.contributor.authorCorrea, Thiago D.
dc.contributor.authorFalavigna, Maicon
dc.contributor.authorMachado, Flavia R. [UNIFESP]
dc.contributor.authorde Assuncao, Murillo S. C.
dc.contributor.authorLobo, Suzana M. A.
dc.contributor.authorDourado, Leticia K.
dc.contributor.authorBerwanger, Otavio
dc.contributor.authorKellum, John A.
dc.contributor.authorBrandao, Nilton
dc.contributor.authorCavalcanti, Alexandre B.
dc.coveragePyrmont
dc.date.accessioned2020-07-13T11:53:05Z
dc.date.available2020-07-13T11:53:05Z
dc.date.issued2017
dc.description.abstractBackground: 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 patientsen
dc.description.abstractand 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.en
dc.description.affiliationHosp Coracao, Res Inst HCor, Sao Paulo, Brazil
dc.description.affiliationHosp Sirio Libanes, Intens Care Unit, Sao Paulo, Brazil
dc.description.affiliationUniv Sao Paulo, Emergency Med Discipline, Sao Paulo, Brazil
dc.description.affiliationHosp Israelita Albert Einstein, Intens Care Unit, Sao Paulo, Brazil
dc.description.affiliationHosp Moinhos de Vento, Porto Alegre, RS, Brazil
dc.description.affiliationUniv Fed Sao Paulo, Hosp Sao Paulo, Anesthesiol Intens Care Unit, Intens Care, Sao Paulo, Brazil
dc.description.affiliationFac Med, Intens Care, Sao Jose Do Rio Preto, Brazil
dc.description.affiliationFac Med, Intens Care Div, Sao Jose Do Rio Preto, Brazil
dc.description.affiliationUniv Pittsburgh, Ctr Crit Care Nephrol, Pittsburgh, PA USA
dc.description.affiliationFed Univ Hlth Sci, Sch Med, Porto Alegre, RS, Brazil
dc.description.affiliationUnifespUniv Fed Sao Paulo, Hosp Sao Paulo, Anesthesiol Intens Care Unit, Intens Care, Sao Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipBaxter Brazil
dc.format.extent175-182
dc.identifierhttps://ccr.cicm.org.au/file/download-article?id=a342bc41-95e2-4486-99a9-2dac08baa423&settings=litnzgC1RAsiHS43rCo4xsUivqk8CYwid1mDE5xgeFg%3D
dc.identifier.citationCritical Care And Resuscitation. Pyrmont, v. 19, n. 2, p. 175-182, 2017.
dc.identifier.issn1441-2772
dc.identifier.urihttps://repositorio.unifesp.br/handle/11600/54381
dc.identifier.wosWOS:000402584300013
dc.language.isoeng
dc.publisherAustralasian Med Publ Co Ltd
dc.relation.ispartofCritical Care And Resuscitation
dc.rightsinfo:eu-repo/semantics/openAccess
dc.titleStudy protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trialen
dc.typeinfo:eu-repo/semantics/article
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