Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial.

Autor:	Zampieri FG; HCor Research Institute, São Paulo, Brazil.; Brazilian Research in Intensive Care Network, São Paulo, Brazil., Machado FR; Brazilian Research in Intensive Care Network, São Paulo, Brazil.; Department of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo, São Paulo, Brazil., Biondi RS; Brazilian Research in Intensive Care Network, São Paulo, Brazil.; Instituto de Cardiologia do Distrito Federal, Brasília, Brazil., Freitas FGR; Brazilian Research in Intensive Care Network, São Paulo, Brazil.; Hospital SEPACO, São Paulo, Brazil., Veiga VC; Brazilian Research in Intensive Care Network, São Paulo, Brazil.; BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil., Figueiredo RC; Hospital Maternidade São José, Centro Universitário do Espírito Santo, Colatina, Brazil., Lovato WJ; Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil., Amêndola CP; Fundação Pio XII, Hospital de Câncer de Barretos, Barretos, Brazil., Serpa-Neto A; Brazilian Research in Intensive Care Network, São Paulo, Brazil.; Hospital Israelita Albert Einstein, São Paulo, Brazil., Paranhos JLR; Santa Casa de Misericórdia de São João Del Rei, São João Del Rei, Brazil., Guedes MAV; Hospital Ana Nery, Salvador, Brazil., Lúcio EA; Hospital São Francisco, Santa Casa de Porto Alegre, Porto Alegre, Brazil., Oliveira-Júnior LC; Hospital Geral Clériston Andrade, Feira de Santana, Brazil., Lisboa TC; Brazilian Research in Intensive Care Network, São Paulo, Brazil.; Hospital Santa Rita, Santa Casa de Porto Alegre, Porto Alegre, Brazil., Lacerda FH; Hospital da Luz, São Paulo, Brazil., Maia IS; Brazilian Research in Intensive Care Network, São Paulo, Brazil.; Hospital Nereu Ramos, Florianópolis, Brazil., Grion CMC; Brazilian Research in Intensive Care Network, São Paulo, Brazil.; Hospital Universitário Regional do Norte do Paraná, Universidade Estadual de Londrina, Londrina, Brazil., Assunção MSC; Hospital Israelita Albert Einstein, São Paulo, Brazil., Manoel ALO; Hospital Paulistano, São Paulo, Brazil., Silva-Junior JM; Hospital do Servidor Público Estadual, São Paulo, Brazil., Duarte P; Hospital Universitário de Cascavel, Cascavel, Brazil., Soares RM; HCor Research Institute, São Paulo, Brazil., Miranda TA; HCor Research Institute, São Paulo, Brazil., de Lima LM; HCor Research Institute, São Paulo, Brazil., Gurgel RM; HCor Research Institute, São Paulo, Brazil., Paisani DM; HCor Research Institute, São Paulo, Brazil., Corrêa TD; Brazilian Research in Intensive Care Network, São Paulo, Brazil.; Hospital Israelita Albert Einstein, São Paulo, Brazil., Azevedo LCP; Brazilian Research in Intensive Care Network, São Paulo, Brazil.; Hospital Sírio Libanês, São Paulo, Brazil., Kellum JA; Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania., Damiani LP; HCor Research Institute, São Paulo, Brazil., Brandão da Silva N; School of Medicine, Federal University of Health Sciences, Porto Alegre, Brazil., Cavalcanti AB; HCor Research Institute, São Paulo, Brazil.; Brazilian Research in Intensive Care Network, São Paulo, Brazil.
Jazyk:	angličtina
Zdroj:	JAMA [JAMA] 2021 Aug 10. Date of Electronic Publication: 2021 Aug 10.
DOI:	10.1001/jama.2021.11684
Abstrakt:	Importance: Intravenous fluids are used for almost all intensive care unit (ICU) patients. Clinical and laboratory studies have questioned whether specific fluid types result in improved outcomes, including mortality and acute kidney injury. Objective: To determine the effect of a balanced solution vs saline solution (0.9% sodium chloride) on 90-day survival in critically ill patients. Design, Setting, and Participants: Double-blind, factorial, randomized clinical trial conducted at 75 ICUs in Brazil. Patients who were admitted to the ICU with at least 1 risk factor for worse outcomes, who required at least 1 fluid expansion, and who were expected to remain in the ICU for more than 24 hours were randomized between May 29, 2017, and March 2, 2020; follow-up concluded on October 29, 2020. Patients were randomized to 2 different fluid types (a balanced solution vs saline solution reported in this article) and 2 different infusion rates (reported separately). Interventions: Patients were randomly assigned 1:1 to receive either a balanced solution (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids. Main Outcomes and Measures: The primary outcome was 90-day survival. Results: Among 11 052 patients who were randomized, 10 520 (95.2%) were available for the analysis (mean age, 61.1 [SD, 17] years; 44.2% were women). There was no significant interaction between the 2 interventions (fluid type and infusion speed; P = .98). Planned surgical admissions represented 48.4% of all patients. Of all the patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment. Patients in both groups received a median of 1.5 L of fluid during the first day after enrollment. By day 90, 1381 of 5230 patients (26.4%) assigned to a balanced solution died vs 1439 of 5290 patients (27.2%) assigned to saline solution (adjusted hazard ratio, 0.97 [95% CI, 0.90-1.05]; P = .47). There were no unexpected treatment-related severe adverse events in either group. Conclusion and Relevance: Among critically ill patients requiring fluid challenges, use of a balanced solution compared with 0.9% saline solution did not significantly reduce 90-day mortality. The findings do not support the use of this balanced solution. Trial Registration: ClinicalTrials.gov Identifier: NCT02875873.
Databáze:	MEDLINE
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