Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients

医学重症监护室随机对照试验生理盐水麻醉病危急性肾损伤重症监护医学外科重症监护内科学

作者

Fernando G. Zampieri,Flávia Ribeiro Machado,Rodrigo Biondi,Flávio Geraldo Rezende Freitas,Viviane Cordeiro Veiga,Rodrigo C. Figueiredo,Wilson José Lovato,Cristina Prata Amêndola,Ary Serpa Neto,Jorge L. R. Paranhos,Marco A.V. Guedes,Eraldo A. Lúcio,Lúcio C. Oliveira-Júnior,Thiago Lisboa,Fábio Holanda Lacerda,Israel Silva Maia,Cíntia Magalhães Carvalho Grion,Murillo Santucci César de Assunção,Airton L. O. Manoel,João Manoel Silva,Péricles Almeida Delfino Duarte,Rafael Marques Soares,Tamiris Abait Miranda,Lucas M. de Lima,Rodrigo M. Gurgel,Denise Paisani,Thiago Domingos Corrêa,Luciano César Pontes Azevedo,John A. Kellum,Lucas Petri Damiani,Nilton Brandão da Silva,Alexandre Biasi Cavalcanti,Rodrigo Biondi,Renato Bueno Chaves,Amanda Ribeiro dos Santos,Vitor Salvatore Barzilai,Flávio Geraldo Rezende Freitas,Nathaly Fonseca Nunes,Rodrigo C. da Cunha,Elijane F. Alves,Rodrigo C. Figueiredo,Rodrigo B. Bortolini,Cintia L. Sartori,Eduardo S. Marques,Maria Auxiliadora de Sousa,Danieri Y. V. Tomotani,Airton L. O. Manoel,Wilson José Lovato,Bruno G. Dantas,Leonardo Carvalho Palma,Fabio Laurindo Silva,Cristina Prata Amêndola,Luciana Coelho Sanches,Fernanda A. M. Scuoteguazza,Ligia Z. de Britto,Ary Serpa,Niklas Söderberg Campos,Fábio Barlem Hohmann,Guilherme Benfatti Olivato,Jorge L. R. Paranhos,Iany G. da Silva,Adilson de C. Meireles,Viviane Cordeiro Veiga,Juliana Chaves Coelho,Maiko Moura Silveira,Agnes C. Lisboa,Marco A.V. Guedes,Luíz Carlos Santana Passos,Daniela C. Dorta,Ramana A. Rangel,Péricles Almeida Delfino Duarte,Eraldo de Azevedo Lúcio,Eduardo B. Tondo,Pablo A.A. Vaz,Paula K. de Oliveira,Lúcio Couto de Oliveira,Paulo H.P. Ferreira,Patrick Harrison Santana Sampaio,Maurício G.S. Serra,Thiago Lisboa,Caroline Fachini,André P. Torelly,Alldren Souza,Fábio Holanda Lacerda,Eliana V. N. Martins,Bruno Adler Maccagnan Pinheiro Besen,Carlos Eduardo Brandão,João Manoel Silva,Flávio W.F. Melo,Flávio A. dos Santos,Israel Silva Maia,Cássio Luis Zandonai,Eduardo Berbigier,Cíntia Magalhães Carvalho Grion,Josiane Festti,Ana Luiza Mezzaroba,José Andrade,Marianne Camargo,Adriano F. Teixeira,José de S. Andrade,Michele Maria Gonçalves de Godoy,Andréia de F. T. de Mendonça,Mara L.F.S. Mendes,Renata C.I.C. Beltrão,Edson Romano,Marcelo Luz Pereira Romano,André Falcão Pedrosa Costa,Jorge Farran,Felipe Dal‐Pizzol,Danusa Damásio,Renata C. Gonçalves,Emerson Boschi,Luiz de F. Ferreira,Rafael Lessa da Costa,Kellen Lopes,Miquéias M.L. Silva,Douglas L.A.B. de Matos,Renata de A. Marques,Glauco Adrieno Westphal,Miriam Machado,Juliano Ramos,Luíz Marcelo Sá Malbouisson,Bruno N. Lucena,Marlus M. Thompson,Lanese Medeiros de Figueiredo,Luana Feitosa Mourão,Thiago Santos Garcês,Israel da S. Maia,Jaqueline F. Rohr,Fernanda Fontanela,Cassia P. B. Martins,Álvaro Réa-Neto,Fernanda Baeumle Reese,Mirella Cristine de Oliveira,André Luiz Nunes Gobatto,Luciana S. de Mattos,Carolaine B. de Oliveira,Meton S. de Alencar,Jussara A. Arraes,João G.T. Alves,Thiago C. De Morais,Antônio A. P. Fagundes,Roberta T. Tallarico,Thais Coutinho,Ronald Torres,Fernando José Ramos,Fernanda C. Athalla,Mauricio H.C. dos Santos,Paulo Maurício Garcia Nosé,Cássia Righy Shinotsuka,Pedro Kurtz,Bruno Guimarães,Luciana Guilhermino Pereira,Raquel B. Jupato,Bruno de Arruda Bravim,Marcos Freitas Knibel,Allan S. da Silva,Vinícius G. de Luca,Niklas Soderberg,Roseny dos Reis Rodrigues,Luis E.P. Pfingsten,Cassiano Teixeira,José H.D. Barth,Giselle C. Pratini,Luiz Dalfior,Márcio H. Kai,S Blecher,Hugo C. A. Urbano,Lucas L. Carvalho,Danielle C. A. Moreira,Ana L. S. Bernardes,Vandack Nobre,Paula Frizera Vassallo,Cecilia Gómez Ravetti,Ho Y. Li,Vivian Vieira Tenório Sales,Renata Guazzelli,Rafael David de Oliveira,Leandro Pozzo,Leandro Utino Taniguchi,Pedro Vitale Mendes,Suzana M Lobo,Miriam Machado,Ana B. B. Camacho,Pablo Oscar Tomba,Fred C. T. Lizidatti,Walter C. G. Baptista,Aline R. Moreira,Manoela M. de Sousa,Marcelo de Oliveira 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 Penna Guimarães,Marcos Cesar Ramos Mello,Mirella Cristine de Oliveira,Fernanda Baeumle Reese,Denise Milioli Ferreira,Fernanda Alves Ferreira Gonçalves,Roberta Muriel Longo Roepke,Bruno Martins Tomazini,Sidiner Mesquita Vaz,Miria Bonjour Laviola,Thiago Domingos Corrêa,Roger Monteiro Alencar,Denise N. Freitas,Heitor P. Póvoas,Liliane B. S. Passos,Juliane de M. Silva

出处

期刊：JAMA [American Medical Association]
日期：2021-08-10 卷期号：326 (9): 818-818 被引量：142

链接

jamanetwork.com nih.gov nih.govdoi.org

标识

DOI：10.1001/jama.2021.11684

摘要

Importance

Intravenous fluids are used for almost all intensive care unit (ICU) patients. Clinical and laboratory studies have questioned whether specific fluid types result in improved outcomes, including mortality and acute kidney injury.

Objective

To determine the effect of a balanced solution vs saline solution (0.9% sodium chloride) on 90-day survival in critically ill patients.

Design, Setting, and Participants

Double-blind, factorial, randomized clinical trial conducted at 75 ICUs in Brazil. Patients who were admitted to the ICU with at least 1 risk factor for worse outcomes, who required at least 1 fluid expansion, and who were expected to remain in the ICU for more than 24 hours were randomized between May 29, 2017, and March 2, 2020; follow-up concluded on October 29, 2020. Patients were randomized to 2 different fluid types (a balanced solution vs saline solution reported in this article) and 2 different infusion rates (reported separately).

Interventions

Patients were randomly assigned 1:1 to receive either a balanced solution (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids.

Main Outcomes and Measures

The primary outcome was 90-day survival.

Results

Among 11 052 patients who were randomized, 10 520 (95.2%) were available for the analysis (mean age, 61.1 [SD, 17] years; 44.2% were women). There was no significant interaction between the 2 interventions (fluid type and infusion speed;P = .98). Planned surgical admissions represented 48.4% of all patients. Of all the patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment. Patients in both groups received a median of 1.5 L of fluid during the first day after enrollment. By day 90, 1381 of 5230 patients (26.4%) assigned to a balanced solution died vs 1439 of 5290 patients (27.2%) assigned to saline solution (adjusted hazard ratio, 0.97 [95% CI, 0.90-1.05];P = .47). There were no unexpected treatment-related severe adverse events in either group.

Conclusion and Relevance

Among critically ill patients requiring fluid challenges, use of a balanced solution compared with 0.9% saline solution did not significantly reduce 90-day mortality. The findings do not support the use of this balanced solution.

Trial Registration

ClinicalTrials.gov Identifier:NCT02875873

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