Fernando G Zampieri1, Luciano C P Azevedo2, Thiago D Corrêa3, Maicon Falavigna4, Flavia R Machado5, Murillo S C de Assunção3, Suzana M A Lobo6, Letícia K Dourado7, Otavio Berwanger7, John A Kellum8, Nilton Brandão9, Alexandre B Cavalcanti7. 1. Research Institute HCor, Hospital of Coração, São Paulo, Brazil. abiasi@hcor.com.br. 2. Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, Brazil. 3. Intensive Care Unit, Hospital Israelita Albert Einstein, São Paulo, Brazil. 4. Hospital Moinhos de Vento, Porto Alegre, Brazil. 5. Anesthesiology Intensive Care Unit, Hospital São Paulo, Federal University of São Paulo, São Paulo, Brazil. 6. Faculty of Medicine, São José do Rio Preto, Brazil. 7. Research Institute HCor, Hospital of Coração, São Paulo, Brazil. 8. Center for Critical Care Nephrology, University of Pittsburgh, Pittsburgh, Penn, USA. 9. School of Medicine, Federal University of Health Sciences, Porto Alegre, Brazil.
Abstract
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; and 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 ??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 ventilationfree 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02875873.
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; and 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 ??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 ventilationfree 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02875873.
Authors: Fernando G Zampieri; Flávia R Machado; Rodrigo S Biondi; Flávio G R Freitas; Viviane C Veiga; Rodrigo C Figueiredo; Wilson J Lovato; Cristina P Amêndola; Ary Serpa-Neto; Jorge L R Paranhos; Marco A V Guedes; Eraldo A Lúcio; Lúcio C Oliveira-Júnior; Thiago C Lisboa; Fábio H Lacerda; Israel S Maia; Cintia M C Grion; Murillo S C Assunção; Airton L O Manoel; João M Silva-Junior; Péricles Duarte; Rafael M Soares; Tamiris A Miranda; Lucas M de Lima; Rodrigo M Gurgel; Denise M Paisani; Thiago D Corrêa; Luciano C P Azevedo; John A Kellum; Lucas P Damiani; Nilton Brandão da Silva; Alexandre B Cavalcanti Journal: JAMA Date: 2021-08-10 Impact factor: 56.272
Authors: Fernando G Zampieri; Flávia R Machado; Rodrigo S Biondi; Flávio G R Freitas; Viviane C Veiga; Rodrigo C Figueiredo; Wilson J Lovato; Cristina P Amêndola; Murillo S C Assunção; Ary Serpa-Neto; Jorge L R Paranhos; José Andrade; Michele M G Godoy; Edson Romano; Felipe Dal Pizzol; Emerson B Silva; Miqueias M L Silva; Miriam C V Machado; Luiz Marcelo S Malbouisson; Airton L O Manoel; Marlus M Thompson; Lanese M Figueiredo; Rafael M Soares; Tamiris A Miranda; Lucas M de Lima; Eliana V Santucci; Thiago D Corrêa; Luciano C P Azevedo; John A Kellum; Lucas P Damiani; Nilton B Silva; Alexandre B Cavalcanti Journal: JAMA Date: 2021-09-07 Impact factor: 56.272
Authors: Laura Evans; Andrew Rhodes; Waleed Alhazzani; Massimo Antonelli; Craig M Coopersmith; Craig French; Flávia R Machado; Lauralyn Mcintyre; Marlies Ostermann; Hallie C Prescott; Christa Schorr; Steven Simpson; W Joost Wiersinga; Fayez Alshamsi; Derek C Angus; Yaseen Arabi; Luciano Azevedo; Richard Beale; Gregory Beilman; Emilie Belley-Cote; Lisa Burry; Maurizio Cecconi; John Centofanti; Angel Coz Yataco; Jan De Waele; R Phillip Dellinger; Kent Doi; Bin Du; Elisa Estenssoro; Ricard Ferrer; Charles Gomersall; Carol Hodgson; Morten Hylander Møller; Theodore Iwashyna; Shevin Jacob; Ruth Kleinpell; Michael Klompas; Younsuck Koh; Anand Kumar; Arthur Kwizera; Suzana Lobo; Henry Masur; Steven McGloughlin; Sangeeta Mehta; Yatin Mehta; Mervyn Mer; Mark Nunnally; Simon Oczkowski; Tiffany Osborn; Elizabeth Papathanassoglou; Anders Perner; Michael Puskarich; Jason Roberts; William Schweickert; Maureen Seckel; Jonathan Sevransky; Charles L Sprung; Tobias Welte; Janice Zimmerman; Mitchell Levy Journal: Intensive Care Med Date: 2021-10-02 Impact factor: 17.440
Authors: Wesley H Self; Matthew W Semler; Jonathan P Wanderer; Li Wang; Daniel W Byrne; Sean P Collins; Corey M Slovis; Christopher J Lindsell; Jesse M Ehrenfeld; Edward D Siew; Andrew D Shaw; Gordon R Bernard; Todd W Rice Journal: N Engl J Med Date: 2018-02-27 Impact factor: 91.245
Authors: Anders Perner; Maurizio Cecconi; Maria Cronhjort; Michael Darmon; Stephan M Jakob; Ville Pettilä; Iwan C C van der Horst Journal: Intensive Care Med Date: 2018-04-25 Impact factor: 17.440