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, 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, BaSICS investigators and the BRICNet members, Rodrigo Biondi, Bruno C R Amaral, Edvar Ferreira R Junior, Andrea Z Abdalla, Flávio G R de Freitas, Nathaly F Nunes, Rodrigo C da Cunha, Elijane F Alves, Rodrigo C Figueiredo, Rodrigo B Bortolini, Cintia L Sartori, Eduardo S Marques, Maria A de Sousa, Danieri Y V Tomotani, Airton L O Manoel, Wilson J Lovato, Bruno G Dantas, Leonardo C Palma, Fábio L da Silva, Cristina P Amendola, Luciana C Sanches, Fernanda A M Scuoteguazza, Ligia Z de Britto, Ary Serpa Neto, Niklas S Campos, Fabio B Hohmann, Guilherme B Olivato, Jorge L R Paranhos, Iany G da Silva, Adilson de C Meireles, Viviane C Veiga, Juliana C Coelho, Maiko M Silveira, Agnes C Lisboa, Marco A V Guedes, Luiz C S Passos, Daniela C Dorta, Ramana A Rangel, Péricles Duarte, Eraldo de A Lúcio, Eduardo B Tondo, Pablo A A Vaz, Paula K de Oliveira, Lúcio C de Oliveira Junior, Paulo H P Ferreira, Patrick H S Sampaio, Maurício G S Serra, Thiago C Lisboa, Caroline Fachini, André P Torelly, Alldren Souza, Fábio H Lacerda, Eliana V N Martins, Bruno A M P Besen, Carlos E Brandão, João M Silva Junior, Flávio W F Melo Junior, Flávio A Dos Santos, Israel S Maia, Cássio L Zandonai, Eduardo Berbigier, Cíntia M C Grion, Josiane Festti, Ana Luiza Mezzaroba, José Andrade, Marianne S Camargo, Adriano F Teixeira, José de S Andrade Neto, Michele M G de Godoy, Andréia de F T de Mendonça, Mara L F S Mendes, Renata C I C Beltrão, Edson Romano, Marcelo L P Romano, Andre F Costa, Jorge Farran, Felipe Dal-Pizzol, Danusa Damásio, Renata Gonçalves, Émerson B da Silva, Luiz de F Ferreira, Rafael L da Costa, Kellen Lopes, Miquéias M L Silva, Douglas L A B de Matos, Renata de A Marques, Glauco A Westphal, Miriam C Machado, Juliano Ramos, Luiz M S Malbouisson, Bruno N Lucena, Marlus M Thompson, Lanese M Figueiredo, Luana F Mourão, Thiago S Garces, Israel da S Maia, Jaqueline F Rohr, Fernanda Fontanela, Cassia P B Martins, Álvaro Rea Neto, Fernanda Reese, Mirella Oliveira, André L N Gobatto, Luciana S de Mattos, Carolaine B de Oliveira, Meton S de Alencar Filho, Jussara A Arraes, João G T Alves, Thiago C De Morais, Antônio A P Fagundes Jr, Roberta T Tallarico, Thais Coutinho, Ronald Torres, Fernando J S Ramos, Fernanda C Athalla, Mauricio H C Dos Santos, Paulo M G Nose, Cássia R Shinotsuka, Pedro Kurtz, Bruno Guimarães, Luciana G Pereira, Raquel B Jupato, Bruno de A Bravim, Marcos F Knibel, Allan S da Silva, Vinícius G de Luca, Niklas Soderberg, Roseny Dos R Rodrigues, Luis E P Pfingsten, Cassiano Teixeira, José H D Barth, Giselle C Pratini, Luiz Dalfior Junior, Márcio H Kai, Sérgio Blecher, Hugo C A Urbano, Lucas L Carvalho, Danielle C A Moreira, Ana L S Bernardes, Vandack A Nobre Júnior, Paula F Vassallo, Cecília G Ravetti, Ho Y Li, Vivian V T Sales, Renata Guazzelli, Rafael D de Oliveira, Leandro Pozzo, Leandro U Taniguchi, Pedro V Mendes, Suzana M A Lobo, Miriam Machado, Ana B B Camacho, Pablo O Tomba, Fred C T Lizidatti, Walter C G Baptista, Aline R Moreira, Manoela M de Sousa, Marcelo O Santos, Karla Moretto, Priscilla A de Martins, Liz M L de Souza, Thiago R Sequeira, Manoel M S Pedrinha, Marcone L S da Rocha, Francisco R V Saleiro, Tatiana M Clementino, Hélio P Guimarães, Marcos C R Mello, Mirella C de Oliveira, Fernanda B Reese, Denise M Ferreira, Fernanda A F Gonçalves, Roberta M L Roepke, Bruno M Tomazini, Sidiner M Vaz, Miria Bonjour Laviola, Thiago D Correa, Roger M Alencar, Denise N Freitas, Heitor P Póvoas Filho, Liliane B S Passos, Juliane de M Silva, 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, BaSICS investigators and the BRICNet members, Rodrigo Biondi, Bruno C R Amaral, Edvar Ferreira R Junior, Andrea Z Abdalla, Flávio G R de Freitas, Nathaly F Nunes, Rodrigo C da Cunha, Elijane F Alves, Rodrigo C Figueiredo, Rodrigo B Bortolini, Cintia L Sartori, Eduardo S Marques, Maria A de Sousa, Danieri Y V Tomotani, Airton L O Manoel, Wilson J Lovato, Bruno G Dantas, Leonardo C Palma, Fábio L da Silva, Cristina P Amendola, Luciana C Sanches, Fernanda A M Scuoteguazza, Ligia Z de Britto, Ary Serpa Neto, Niklas S Campos, Fabio B Hohmann, Guilherme B Olivato, Jorge L R Paranhos, Iany G da Silva, Adilson de C Meireles, Viviane C Veiga, Juliana C Coelho, Maiko M Silveira, Agnes C Lisboa, Marco A V Guedes, Luiz C S Passos, Daniela C Dorta, Ramana A Rangel, Péricles Duarte, Eraldo de A Lúcio, Eduardo B Tondo, Pablo A A Vaz, Paula K de Oliveira, Lúcio C de Oliveira Junior, Paulo H P Ferreira, Patrick H S Sampaio, Maurício G S Serra, Thiago C Lisboa, Caroline Fachini, André P Torelly, Alldren Souza, Fábio H Lacerda, Eliana V N Martins, Bruno A M P Besen, Carlos E Brandão, João M Silva Junior, Flávio W F Melo Junior, Flávio A Dos Santos, Israel S Maia, Cássio L Zandonai, Eduardo Berbigier, Cíntia M C Grion, Josiane Festti, Ana Luiza Mezzaroba, José Andrade, Marianne S Camargo, Adriano F Teixeira, José de S Andrade Neto, Michele M G de Godoy, Andréia de F T de Mendonça, Mara L F S Mendes, Renata C I C Beltrão, Edson Romano, Marcelo L P Romano, Andre F Costa, Jorge Farran, Felipe Dal-Pizzol, Danusa Damásio, Renata Gonçalves, Émerson B da Silva, Luiz de F Ferreira, Rafael L da Costa, Kellen Lopes, Miquéias M L Silva, Douglas L A B de Matos, Renata de A Marques, Glauco A Westphal, Miriam C Machado, Juliano Ramos, Luiz M S Malbouisson, Bruno N Lucena, Marlus M Thompson, Lanese M Figueiredo, Luana F Mourão, Thiago S Garces, Israel da S Maia, Jaqueline F Rohr, Fernanda Fontanela, Cassia P B Martins, Álvaro Rea Neto, Fernanda Reese, Mirella Oliveira, André L N Gobatto, Luciana S de Mattos, Carolaine B de Oliveira, Meton S de Alencar Filho, Jussara A Arraes, João G T Alves, Thiago C De Morais, Antônio A P Fagundes Jr, Roberta T Tallarico, Thais Coutinho, Ronald Torres, Fernando J S Ramos, Fernanda C Athalla, Mauricio H C Dos Santos, Paulo M G Nose, Cássia R Shinotsuka, Pedro Kurtz, Bruno Guimarães, Luciana G Pereira, Raquel B Jupato, Bruno de A Bravim, Marcos F Knibel, Allan S da Silva, Vinícius G de Luca, Niklas Soderberg, Roseny Dos R Rodrigues, Luis E P Pfingsten, Cassiano Teixeira, José H D Barth, Giselle C Pratini, Luiz Dalfior Junior, Márcio H Kai, Sérgio Blecher, Hugo C A Urbano, Lucas L Carvalho, Danielle C A Moreira, Ana L S Bernardes, Vandack A Nobre Júnior, Paula F Vassallo, Cecília G Ravetti, Ho Y Li, Vivian V T Sales, Renata Guazzelli, Rafael D de Oliveira, Leandro Pozzo, Leandro U Taniguchi, Pedro V Mendes, Suzana M A Lobo, Miriam Machado, Ana B B Camacho, Pablo O Tomba, Fred C T Lizidatti, Walter C G Baptista, Aline R Moreira, Manoela M de Sousa, Marcelo O Santos, Karla Moretto, Priscilla A de Martins, Liz M L de Souza, Thiago R Sequeira, Manoel M S Pedrinha, Marcone L S da Rocha, Francisco R V Saleiro, Tatiana M Clementino, Hélio P Guimarães, Marcos C R Mello, Mirella C de Oliveira, Fernanda B Reese, Denise M Ferreira, Fernanda A F Gonçalves, Roberta M L Roepke, Bruno M Tomazini, Sidiner M Vaz, Miria Bonjour Laviola, Thiago D Correa, Roger M Alencar, Denise N Freitas, Heitor P Póvoas Filho, Liliane B S Passos, Juliane de M Silva
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.
Conflict of interest statement
Conflict of Interest Disclosures: Dr Zampieri reported receiving grants from Ionis Pharmaceuticals US and Bactiguard Sweden. Dr Veiga reported receiving personal fees from Aspen and Pfizer. Dr Serpa-Neto reported receiving personal fees from Drager. Dr Azevedo reported receiving lecture fees from Pfizer and Baxter, consulting fees from Halex-Istar, and research grants from Ache Pharmaceutical. Dr Kellum reported receiving grants and personal fees from Baxter. No other disclosures were reported.
Figures
Source: PubMed