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Randomized Controlled Trial Multicenter Study Comparative Study
Effect of Slower vs Faster Intravenous Fluid Bolus Rates on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial.
- Fernando G Zampieri, Flávia R Machado, Rodrigo S Biondi, FreitasFlávio G RFGRBrazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.Hospital SEPACO, São Paulo, Brazil., 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, GodoyMichele M GMMGHospital das Clínicas da Universidade Federal de Pernambuco, Recife, Brazil., 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, AzevedoLuciano C PLCPBrazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.Hospital Sírio Libanês, São Paulo, Brazil., John A Kellum, Lucas P Damiani, Nilton B Silva, Alexandre B Cavalcanti, and BaSICS investigators and the BRICNet members.
- HCor Research Institute, São Paulo, Brazil.
- JAMA. 2021 Sep 7; 326 (9): 830-838.
ImportanceSlower 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.ObjectiveTo 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 ParticipantsUnblinded 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).InterventionsPatients 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 MeasuresThe primary end point was 90-day survival.ResultsOf 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 RelevanceAmong 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 RegistrationClinicalTrials.gov Identifier: NCT02875873.
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