Fernando G Zampieri1,2, Flávia R Machado2,3, Rodrigo S Biondi2,4, Flávio G R Freitas2,5, Viviane C Veiga2,6, Rodrigo C Figueiredo7, Wilson J Lovato8, Cristina P Amêndola9, Murillo S C Assunção10, Ary Serpa-Neto2,10, Jorge L R Paranhos11, José Andrade12, Michele M G Godoy13, Edson Romano14, Felipe Dal Pizzol2,15, Emerson B Silva16, Miqueias M L Silva17, Miriam C V Machado18, Luiz Marcelo S Malbouisson19, Airton L O Manoel20, Marlus M Thompson21, Lanese M Figueiredo22, Rafael M Soares1, Tamiris A Miranda1, Lucas M de Lima1, Eliana V Santucci1, Thiago D Corrêa2,10, Luciano C P Azevedo2,23, John A Kellum24, Lucas P Damiani1, Nilton B Silva25, Alexandre B Cavalcanti1,2. 1. HCor Research Institute, São Paulo, Brazil. 2. Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil. 3. Department of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil. 4. Instituto de Cardiologia do Distrito Federal, Brasília, Brazil. 5. Hospital SEPACO, São Paulo, Brazil. 6. BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil. 7. Hospital Maternidade São José, Centro Universitário do Espírito Santo (UNESC), Colatina, Brazil. 8. Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, Brazil. 9. Fundação Pio XII, Hospital de Câncer de Barretos, Barretos, Brazil. 10. Hospital Israelita Albert Einstein, São Paulo, Brazil. 11. Santa Casa de Misericórdia de São João Del Rei, São João Del Rei, Brazil. 12. Hospital Geral de Vitória da Conquista, Vitória da Conquista, Brazil. 13. Hospital das Clínicas da Universidade Federal de Pernambuco, Recife, Brazil. 14. HCor, São Paulo, Brazil. 15. Hospital São José, Criciúma, Brazil. 16. Hospital Geral de Caxias do Sul, Caxias do Sul, Brazil. 17. Hospital SAMUR, Vitória da Conquista, Brazil. 18. Centro Hospitar UNIMED, Joinville, Brazil. 19. Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil. 20. Hospital Paulistano, São Paulo, Brazil. 21. Hospital Evangélico Cachoeiro do Itapemirim, Cachoeiro do Itapemirim, Brazil. 22. Hospital Distrital Doutor Evandro Ayres de Moura, Fortaleza, Brazil. 23. Hospital Sírio Libanês, São Paulo, Brazil. 24. Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. 25. School of Medicine, Federal University of Health Sciences, Porto Alegre, Brazil.
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.
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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