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平衡溶液静脉输注与生理盐水相比不能降低危重病人的90天死亡率
作者:小柯机器人 发布时间:2021/8/14 20:39:23

巴西圣保罗HCor研究所Alexandre B. Cavalcanti团队研究了平衡溶液与0.9%盐水静脉输注治疗对危重病人死亡率的影响。2021年8月10日,《美国医学会杂志》发表了这项成果。

几乎所有重症监护病房(ICU)病人都需要静脉输液。临床和实验室研究质疑特定的液体类型是否能改善预后,包括死亡率和急性肾损伤。

为了研究比较平衡溶液与生理盐水(0.9%氯化钠)对危重患者90天生存率的影响,研究组在巴西75个ICU病房进行了一项双盲、析因、随机临床试验。2017年5月29日至2020年3月2日,招募至少有1个危险因素导致预后更差、至少需要1次液体扩容且预计在ICU停留24小时以上的患者;后续随访于2020年10月29日结束。将患者按1:1随机分配输注两种不同的液体类型(本文中报道的平衡溶液和盐水溶液)和两种不同的输注速率(分别报道)。其中5522例接受静脉输注平衡溶液,5530例接受输注0.9%的生理盐水。主要结局为90天生存率。

11052名患者被随机分配,其中10520例(95.2%)可用于分析,平均年龄为61.1岁,44.2%是女性。两种干预措施之间没有显著交互作用(液体类型和输液速度)。计划手术入院的患者占48.4%。在所有患者中,60.6%有低血压或使用血管加压药,44.3%需要机械通气。

两组患者在入组后的第一天接受输注了中位1.5 L液体。到第90天,输注平衡溶液的5230名患者中有1381名(26.4%)死亡,而输注生理盐水的5290名患者中有1439名(27.2%)死亡,组间差异不显著。两组均未发生与治疗相关的意外严重不良事件。

研究结果表明,在需要液体输注的危重患者中,使用平衡溶液与0.9%盐水溶液相比,并没有显著降低90天死亡率。

附:英文原文

Title: Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial

Author: 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. Assuno, Airton L. O. Manoel, Joo 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 Brando da Silva, Alexandre B. Cavalcanti, BaSICS investigators and the BRICNet members, Rodrigo Biondi, Renato B. Chaves, Amanda R. Santos, Vitor S. Barzilai, 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, 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

Issue&Volume: 2021-08-10

Abstract:

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 11052 patients who were randomized, 10520 (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.

DOI: 10.1001/jama.2021.11684

Source: https://jamanetwork.com/journals/jama/fullarticle/2783039

期刊信息

JAMA-Journal of The American Medical Association:《美国医学会杂志》,创刊于1883年。隶属于美国医学协会,最新IF:51.273
官方网址:https://jamanetwork.com/
投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex