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.

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.

[Cancer disease should not be a limitative factor for admission of high risk surgical patients to an intensive care unit]. / A doença oncológica não deve ser um fator limitante para admissão na UTI de pacientes submetidos a cirurgias de alto risco.

BACKGROUND AND OBJECTIVES: Oncologic diseases are conditions that have influence in the treatment offered to affected patients. The aim of this study was to compare hospitalar outcome of oncologic and non oncologic patients submitted to high risk elective surgery. METHODS: Prospective, observational cohort study realized in an ICU of a tertiary hospital during the period between 04/01/2005 and 07/31/2005. Demographic data, APACHE II and MODS scores and laboratorial and hemodynamic variables were collected and complications like re-intervention need for mechanical ventilation, red blood cell transfusions and pulmonary artery catheter use during the post-operative period were evaluated. All patients were followed until hospital discharge or death. T student and Mann Whitney tests were used to compare numerical variables. Chi-square test was used to compare categorical variables. A p < 0.05 was considered as significant. RESULTS: 119 patients were included in the study. 43 were oncologic and 76 were non-oncologic. 52.9% were female. Mean age was 65.1 ± 14.1 years. Mean APACHE II score was 16.5 ± 5.8 and MODS median was 3 (2-6). Median length of surgery was 5 (3.3-7) hours and ICU and hospital mortality were 10.9% and 25.2%, respectively. Oncologic patients had greater length of hospital stay and length of stay before surgery. These results were statistically significant. Hospital mortality of oncologic patients was not greater than non-oncologic patients (22.4% versus 30.2%, p = 0.32). CONCLUSIONS: In this series, oncologic patients submitted to high risk surgery had the same mortality rate as non-onconlogic patients with similar disease severity.

[Hyperlactatemia at ICU admission is a morbid-mortality determinant in high risk non-cardiac surgeries]. / Hiperlactatemia à admissão na UTI é um determinante de morbimortalidade em intervenções cirúrgicas não cardíacas de alto risco.

BACKGROUND AND OBJECTIVES: One of the greatest challenges found by the intensivists in their daily activities is tissue hipoperfusion control. Blood lactate is generally accepted as a marker of tissular hypoxia and several studies have demonstrated good correlation between blood lactate and prognosis during shock and resuscitation. The aim of this study was to evaluate the clinical utility of arterial blood lactate as a marker of morbidity and mortality in critically ill patients in the post-operative period of high risk non-cardiac surgeries. METHODS: Prospective and observational cohort study realized in an ICU of a tertiary hospital during a four month period. Demographic data of the patients submitted to high risk surgeries were collected, besides arterial lactate measures and number and type of complications in the post-operative period. To the statistic analysis was considered as significant a p < 0.05. The predictive ability of the indexes to differentiate survivors from non-survivors was tested using ROC curves. Lenght of ICU stay estimation where calculated by Kaplan Meier method. RESULTS: Were included 202 patients. 50.2% were female and their mean age was 66.5 ± 13.6 years. APACHE II score was 17.4 ± 3.0 and the median of MODS score was 4 (2-6). Median lenght of surgeries was 4h (3-6h). 70.7% of the surgeries were elective ones. ICU and hospital mortality were 15.6% and 33.7%, respectively. The best lactate value to discriminate mortality was 3.2 mmol/L, with sensitivity of 62.5%, specificity of 78.8% and an area under the curve of 0.7. 62.5% of patients with lactate > 3.2 did not survive versus 21.2% of survivors (OR = 2.95 IC95% 1.98- 4.38, p < 0.0001). ICU lenght of stay was greater when > 3.2 mmol/L (log rank 0.007) lactate. CONCLUSIONS: High risk patients submitted to non cardiac surgeries and admitted to the ICU with hiperlactatemia, defined as an arterial lactate > 3.2 mmol/L, are prone to a longer ICU lenght of stay and to die.

A doença oncológica não deve ser um fator limitante para admissão na UTI de pacientes submetidos a cirurgias de alto risco / Cancer disease should not be a limitative factor for admission of high risk surgical patients to an intensive care unit

JUSTIFICATIVA E OBJETIVOS: A doença oncológica per se é uma condição que muitas vezes influencia no tratamento dispensado ao paciente. O objetivo do presente estudo foi comparar o desfecho hospitalar de pacientes oncológicos e não oncológicos submetidos à procedimentos cirúrgicos eletivos com alto risco de óbito. MÉTODO: Estudo de coorte prospectivo observacional, realizado em UTI de hospital terciário no período de 01 de abril a 31 de julho de 2005. Foram coletados dados demográficos, escore APACHE II, MODS, variáveis hemodinâmicas, laboratoriais e avaliadas complicações definidas como re-operação, necessidade de ventilação mecânica, transfusão sangüínea e uso de cateter de artéria pulmonar no pós-operatório desses pacientes. Todos foram acompanhados até alta ou o óbito hospitalar. Para variáveis numéricas foi utilizado o teste t de Student e Mann-Whitney, para variáveis categóricas o teste do Qui-quadrado sendo considerado significativo o valor de p < 0,05. RESULTADOS: Foram incluídos no estudo 119 pacientes, 43 não oncológicos e 76 oncológicos, 52,9 por cento eram do sexo feminino. A média de idade foi 65,1 ± 14,1 anos, o escore médio de APACHE II 16,5 ± 5,8 e a mediana do MODS de 3 (2-6). A duração mediana da intervenção cirúrgica foi de 5 (3,3-7) horas e a mortalidade na UTI e hospitalar foram 10,9 por cento e 25,2 por cento, respectivamente. Os pacientes oncológicos apresentaram maiores tempos de internação hospitalar e de internação antes da cirurgia, sendo estes resultados estatisticamente significativos. A mortalidade hospitalar dos pacientes oncológicos não foi superior a dos pacientes sem neoplasia (22,4 por cento versus 30,2 por cento, p = 0,32). CONCLUSÕES: Nesta observação os pacientes oncológicos, submetidos à procedimentos cirúrgicos de alto risco, apresentaram mortalidade semelhante aos pacientes não oncológicos com gravidade de doença similar.

BACKGROUND AND OBJECTIVES: Oncologic diseases are conditions that have influence in the treatment offered to affected patients. The aim of this study was to compare hospitalar outcome of oncologic and non oncologic patients submitted to high risk elective surgery. METHODS: Prospective, observational cohort study realized in an ICU of a tertiary hospital during the period between 04/01/2005 and 07/31/2005. Demographic data, APACHE II and MODS scores and laboratorial and hemodynamic variables were collected and complications like re-intervention need for mechanical ventilation, red blood cell transfusions and pulmonary artery catheter use during the post-operative period were evaluated. All patients were followed until hospital discharge or death. T student and Mann Whitney tests were used to compare numerical variables. Chi-square test was used to compare categorical variables. A p < 0.05 was considered as significant. RESULTS: 119 patients were included in the study. 43 were oncologic and 76 were non-oncologic. 52.9 percent were female. Mean age was 65.1 ± 14.1 years. Mean APACHE II score was 16.5 ± 5.8 and MODS median was 3 (2-6). Median length of surgery was 5 (3.3-7) hours and ICU and hospital mortality were 10.9 percent and 25.2 percent, respectively. Oncologic patients had greater length of hospital stay and length of stay before surgery. These results were statistically significant. Hospital mortality of oncologic patients was not greater than non-oncologic patients (22.4 percent versus 30.2 percent, p = 0.32). CONCLUSIONS: In this series, oncologic patients submitted to high risk surgery had the same mortality rate as non-onconlogic patients with similar disease severity.

Hiperlactatemia à admissão na UTI é um determinante de morbimortalidade em intervenções cirúrgicas não cardíacas de alto risco / Hyperlactatemia at ICU admission is a morbid-mortality determinant in high risk non-cardiac surgeries

JUSTIFICATIVA E OBJETIVOS: Um dos maiores desafios dos médicos intensivistas é o controle da hipoperfusão tecidual, sendo o lactato sérico classicamente aceito como indicador de hipóxia tecidual. Deste modo, estudos demonstraram boa correlação entre o lactato e o prognóstico no choque e durante a reanimação. O objetivo deste estudo foi avaliar a utilidade clínica do lactato arterial à admissão na UTI como indicador de morbimortalidade em pacientes críticos no pós-operatório de intervenções cirúrgicas não cardíacas de alto risco. MÉTODO: Estudo de coorte prospectivo observacional, realizado em UTI de hospital terciário no período de 4 meses. Foram coletados dados demográficos, lactato arterial e complicações no pós-operatório de pacientes submetidos à intervenções cirúrgicas de grande porte. Para análise estatística foi considerado significativo p < 0,05. A habilidade preditiva dos índices em diferenciar sobreviventes e não sobreviventes foi verificada utilizando curvas ROC. Estimativas de permanência na UTI foram calculadas utilizando o método de Kaplan Méier. RESULTADOS: Foram incluídos 202 pacientes, sendo 50,2 por cento do sexo feminino, com média da idade de 66,5 ± 13,6 anos, APACHE II 17,4 ± 3,0, mediana do MODS 4 (2-6). A duração mediana das intervenções foram 4h (3 a 6h), 70,7 por cento de cirurgias eletivas, a mortalidade na UTI e hospitalar foram 15,6 por cento e 33,7 por cento, respectivamente. O melhor valor de lactato que discriminou mortalidade foi 3,2 mmol/L, sensibilidade de 62,5 por cento e especificidade de 78,8 por cento, área sob a curva de 0,7. Não sobreviveram 62,5 por cento dos pacientes com lactato > 3,2 versus 21,2 por cento de sobreviventes (OR = 2,95 IC95 por cento 1,98 - 4,38, p < 0,0001). O tempo de permanência na UTI foi mais elevado quando lactato > 3,2 mmol/L (log rank 0,007). CONCLUSÕES: Os pacientes cirúrgicos não cardíacos de alto risco admitidos na UTI com hiperlactatemia, definida com...

BACKGROUND AND OBJECTIVES: One of the greatest challenges found by the intensivists in their daily activities is tissue hipoperfusion control. Blood lactate is generally accepted as a marker of tissular hypoxia and several studies have demonstrated good correlation between blood lactate and prognosis during shock and resuscitation. The aim of this study was to evaluate the clinical utility of arterial blood lactate as a marker of morbidity and mortality in critically ill patients in the post-operative period of high risk non-cardiac surgeries. METHODS: Prospective and observational cohort study realized in an ICU of a tertiary hospital during a four month period. Demographic data of the patients submitted to high risk surgeries were collected, besides arterial lactate measures and number and type of complications in the post-operative period. To the statistic analysis was considered as significant a p < 0.05. The predictive ability of the indexes to differentiate survivors from non-survivors was tested using ROC curves. Lenght of ICU stay estimation where calculated by Kaplan Meier method. RESULTS: Were included 202 patients. 50.2 percent were female and their mean age was 66.5 ± 13.6 years. APACHE II score was 17.4 ± 3.0 and the median of MODS score was 4 (2-6). Median lenght of surgeries was 4h (3-6h). 70.7 percent of the surgeries were elective ones. ICU and hospital mortality were 15.6 percent and 33.7 percent, respectively. The best lactate value to discriminate mortality was 3.2 mmol/L, with sensitivity of 62.5 percent, specificity of 78.8 percent and an area under the curve of 0.7. 62.5 percent of patients with lactate > 3.2 did not survive versus 21.2 percent of survivors (OR = 2.95 IC95 percent 1.98- 4.38, p < 0.0001). ICU lenght of stay was greater when > 3.2 mmol/L (log rank 0.007) lactate. CONCLUSIONS: High risk patients submitted to non cardiac surgeries and admitted to the ICU with hiperlactatemia, defined...