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Original Investigation
August 10, 2021

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

Author Affiliations
  • 1HCor Research Institute, São Paulo, Brazil
  • 2Brazilian Research in Intensive Care Network, São Paulo, Brazil
  • 3Department of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo, São Paulo, Brazil
  • 4Instituto de Cardiologia do Distrito Federal, Brasília, Brazil
  • 5Hospital SEPACO, São Paulo, Brazil
  • 6BP–A Beneficência Portuguesa de São Paulo, São Paulo, Brazil
  • 7Hospital Maternidade São José, Centro Universitário do Espírito Santo, Colatina, Brazil
  • 8Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil
  • 9Fundação Pio XII, Hospital de Câncer de Barretos, Barretos, Brazil
  • 10Hospital Israelita Albert Einstein, São Paulo, Brazil
  • 11Santa Casa de Misericórdia de São João Del Rei, São João Del Rei, Brazil
  • 12Hospital Ana Nery, Salvador, Brazil
  • 13Hospital São Francisco, Santa Casa de Porto Alegre, Porto Alegre, Brazil
  • 14Hospital Geral Clériston Andrade, Feira de Santana, Brazil
  • 15Hospital Santa Rita, Santa Casa de Porto Alegre, Porto Alegre, Brazil
  • 16Hospital da Luz, São Paulo, Brazil
  • 17Hospital Nereu Ramos, Florianópolis, Brazil
  • 18Hospital Universitário Regional do Norte do Paraná, Universidade Estadual de Londrina, Londrina, Brazil
  • 19Hospital Paulistano, São Paulo, Brazil
  • 20Hospital do Servidor Público Estadual, São Paulo, Brazil
  • 21Hospital Universitário de Cascavel, Cascavel, Brazil
  • 22Hospital Sírio Libanês, São Paulo, Brazil
  • 23Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 24School of Medicine, Federal University of Health Sciences, Porto Alegre, Brazil
JAMA. 2021;326(9):818-829. doi:10.1001/jama.2021.11684
Visual Abstract. Intravenous Treatment With a Balanced Solution vs Saline Solution on Mortality in Critically Ill Patients
Intravenous Treatment With a Balanced Solution vs Saline Solution on Mortality in Critically Ill Patients
Key Points

Question  Among intensive care patients requiring intravenous fluid challenges, does the use of a balanced solution compared with saline solution (0.9% sodium chloride) improve 90-day survival?

Findings  In this randomized clinical that included 10 520 patients in intensive care units, intravenous fluid bolus treatment with a balanced solution vs saline solution resulted in 90-day mortality of 26.4% vs 27.2%, respectively, a difference that was not statistically significant.

Meaning  Among critically ill patients requiring fluid challenges, treatment with a balanced solution compared with saline solution did not significantly reduce 90-day mortality.

Abstract

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

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    2 Comments for this article
    We've Been Here Before on Many Occasions
    Richard Reiling, Clinical Professor | Retired, Wright State University School of Medicine
    The question about use of saline vs a balanced solution for resuscitation and fluid management has been around for years. We did a similar study in the late sixties or early seventies in Boston and the result was the same. At that time, the balanced solution was Ringer's lactate, but the concept was the same.

    I suppose in 10 or more years other studies will be done and the result will be the same again.

    Maybe, just maybe, someone will come up with a more 'magical' solution, but that's a questionable probability.
    CONFLICT OF INTEREST: None Reported
    Balanced, Yes. Physiological, No!
    Jan van der Meulen, M.D., PhD. | General Practice deJagerweg, Dordrecht, the Netherlands.
    Why should one infuse a vasodilator to critically ill patients? The balanced solution contains per 100 ml 368 mg of sodium acetate trihydrate i.e. per liter 27 mEq acetate (1). In 1979 the following warning was given: acetate, used as a buffer in intravenous solutions, has vasoactive properties. This should be recognized when such solutions are administered to patients with limited capacity to compensate for sudden vasodilation (2).

    References:
    1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.pdf
    2. Olinger GN, Werner PH, Bonchek LI, Boerboom LE. Vasodilator effects of the sodium acetate in pooled protein fraction. Ann Surg. 1979;190(3):305-311. doi:10.1097/00000658-197909000-00005
    CONFLICT OF INTEREST: None Reported
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