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Original Investigation
August 10, 2021

Effect of Slower vs Faster Intravenous Fluid Bolus Rates 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 (BRICNet), São Paulo, Brazil
  • 3Department of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP), 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 (UNESC), 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 Geral de Vitória da Conquista, Vitória da Conquista, Brazil
  • 13Hospital das Clínicas da Universidade Federal de Pernambuco, Recife, Brazil
  • 14HCor, São Paulo, Brazil
  • 15Hospital São José, Criciúma, Brazil
  • 16Hospital Geral de Caxias do Sul, Caxias do Sul, Brazil
  • 17Hospital SAMUR, Vitória da Conquista, Brazil
  • 18Centro Hospitar UNIMED, Joinville, Brazil
  • 19Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
  • 20Hospital Paulistano, São Paulo, Brazil
  • 21Hospital Evangélico Cachoeiro do Itapemirim, Cachoeiro do Itapemirim, Brazil
  • 22Hospital Distrital Doutor Evandro Ayres de Moura, Fortaleza, Brazil
  • 23Hospital Sírio Libanês, São Paulo, Brazil
  • 24Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 25School of Medicine, Federal University of Health Sciences, Porto Alegre, Brazil
JAMA. 2021;326(9):830-838. doi:10.1001/jama.2021.11444
Visual Abstract. Slower vs Faster Intravenous Fluid Bolus Rates and Mortality in Critically Ill Patients
Slower vs Faster Intravenous Fluid Bolus Rates and Mortality in Critically Ill Patients
Key Points

Question  Does a slower infusion rate compared with a control rate affect 90-day survival of critically ill patients requiring fluid challenges?

Findings  In this randomized clinical trial that included 10 520 patients in intensive care units, treatment with fluid boluses at 333 mL/h vs 999 mL/h resulted in 90-day mortality of 26.6% vs 27.0%, a difference that was not statistically significant.

Meaning  Among critically ill patients requiring fluid challenges, infusing at a slower rate compared with a faster rate did not reduce 90-day mortality.

Abstract

Importance  Slower intravenous fluid infusion rates could reduce the formation of tissue edema and organ dysfunction in critically ill patients; however, there are no data to support different infusion rates during fluid challenges for important outcomes such as mortality.

Objective  To determine the effect of a slower infusion rate vs control infusion rate on 90-day survival in patients in the intensive care unit (ICU).

Design, Setting, and Participants  Unblinded randomized factorial clinical trial in 75 ICUs in Brazil, involving 11 052 patients requiring at least 1 fluid challenge and with 1 risk factor for worse outcomes were randomized from May 29, 2017, to March 2, 2020. Follow-up was concluded on October 29, 2020. Patients were randomized to 2 different infusion rates (reported in this article) and 2 different fluid types (balanced fluids or saline, reported separately).

Interventions  Patients were randomized to receive fluid challenges at 2 different infusion rates; 5538 to the slower rate (333 mL/h) and 5514 to the control group (999 mL/h). Patients were also randomized to receive balanced solution or 0.9% saline using a factorial design.

Main Outcomes and Measures  The primary end point was 90-day survival.

Results  Of all randomized patients, 10 520 (95.2%) were analyzed (mean age, 61.1 years [SD, 17.0 years]; 44.2% were women) after excluding duplicates and consent withdrawals. Patients assigned to the slower rate received a mean of 1162 mL on the first day vs 1252 mL for the control group. By day 90, 1406 of 5276 patients (26.6%) in the slower rate group had died vs 1414 of 5244 (27.0%) in the control group (adjusted hazard ratio, 1.03; 95% CI, 0.96-1.11; P = .46). There was no significant interaction between fluid type and infusion rate (P = .98).

Conclusions and Relevance  Among patients in the intensive care unit requiring fluid challenges, infusing at a slower rate compared with a faster rate did not reduce 90-day mortality. These findings do not support the use of a slower infusion rate.

Trial Registration  ClinicalTrials.gov Identifier: NCT02875873

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