Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure <= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt

Reestruturação produtiva no setor bancário brasileiro e sofrimento dos caixas executivos: um estudo de caso Restructuring in the work of Brazilian banks and the consequences on the psyche of their workers

este artigo tem por objetivo apresentar uma análise das repercussões das mudanças no psiquismo em trabalhadores que desempenham a função de caixas de um grande banco estatal brasileiro em processo de reestruturação produtiva, com uma atenção particular às formas de mobilização da inteligência, da personalidade no trabalho e na utilização de estratégias coletivas de defesa para enfrentar o sofrimento. Foi utilizada para a pesquisa e a análise dos dados, a metodologia da Psicodinâmica do Trabalho, disciplina que estuda em que situações as condições organizacionais determinam o sentido e a mobilização subjetiva no trabalho, e também as repercussões dessas condições sobre a saúde dos trabalhadores. Foi constatado que a mobilização psíquica provocada pelas mudanças é intensa, a partir de sentimentos de insegurança, estranhamento, desorientação e impotência diante das incertezas das propostas da empresa, sendo a perda do contato com o cliente uma das maiores fontes de sofrimento para o grupo. Há um sentimento de desvalorização, manifestado nas queixas sobre o achatamento salarial, na perda do status que a função proporcionava e na desestruturação de um saber acumulado ao longo dos anos de exercício da função. O sofrimento psíquico dos caixas, provocados pelas reestruturações no trabalho, atingem níveis preocupantes, pois as novas formas de organização do trabalho estão destruindo a imagem do caixa como um profissional e reduzindo a possibilidade de serem reconhecidos pelo exercício da atividade.<br>The objective of this article is to study the consequences in the work in Brazilian banks after the deep changes, mainly after the implementation of the economical plan from 1994 - "Plano Real". In their efforts to adapt themselves to the new economical contingency of the country and to the increase in competition in this sector, the banks have restructured their organisations, downsized their staff, replaced workforce for computerizing systems which allow the treatment of data using less workers. These changes have not occured without consequences for the workers. These people have had to adapt themselves to the new situation, to the increase of pressure of work, of the exposure to risks and, to the end of job stability. Based on a research carried out with cashiers from a bank, an analysis of the repercussion of those changes for the workers' psyche was done with particular attention to the ways of the mobilization of intelligence and of their personality in the work and in the use of collective strategies of defence to fight the suffering. In order to carry out the research and to analyse the data, we have used the theoretical and methodological approaches of the Psychodynamics of Work, a subject which studies in which situations the conditions of the organisations determine the direction and the subjective mobilization in the work as well as the consequences of those conditions on the workers' health

Infection and Immunity

Texto completo: acesso restrito. p. 1236-1243Most inbred strains of mice, like the BALB/c strain, are susceptible to Leishmania amazonensis infections and resistant to Leishmania braziliensis infections. This parasite-related difference could result from the activity of an L. amazonensis-specific virulence factor. In agreement with this hypothesis, it is shown here that the intravenous injection of BALB/c mice with L. amazonensis amastigote extract (LaE) but not the L. braziliensis extract confers susceptibility to L. braziliensis infection. This effect was associated with high circulating levels of IgG1 anti-L. amazonensis antibodies and with an increase in interleukin-4 (IL-4) production and a decrease in gamma interferon production by draining lymph node cells. Moreover, the effect was absent in IL-4-knockout mice. The biological activity in the LaE was not mediated by amphiphilic molecules and was inhibited by pretreatment of the extract with irreversible serine protease inhibitors. These findings indicate that the LaE contains a virulence-related factor that (i) enhances the Leishmania infection by promoting Th2-type immune responses, (ii) is not one of the immunomodulatory Leishmania molecules described so far, and (iii) is either a serine protease or has an effect that depends on that protease activity. In addition to being Leishmania species specific, the infection-enhancing activity was also shown to depend on the host genetic makeup, as LaE injections did not affect the susceptibility of C57BL/6 mice to L. braziliensis infection. The identification of Leishmania molecules with infection-enhancing activity could be important for the development of a vaccine, since the up- or downmodulation of the immune response against a virulence factor could well contribute to controlling the infection

Enhancement of Experimental Cutaneous Leishmaniasis by Leishmania Molecules Is Dependent on Interleukin-4, Serine Protease/Esterase Activity, and Parasite and Host Genetic Backgrounds ▿

Most inbred strains of mice, like the BALB/c strain, are susceptible to Leishmania amazonensis infections and resistant to Leishmania braziliensis infections. This parasite-related difference could result from the activity of an L. amazonensis-specific virulence factor. In agreement with this hypothesis, it is shown here that the intravenous injection of BALB/c mice with L. amazonensis amastigote extract (LaE) but not the L. braziliensis extract confers susceptibility to L. braziliensis infection. This effect was associated with high circulating levels of IgG1 anti-L. amazonensis antibodies and with an increase in interleukin-4 (IL-4) production and a decrease in gamma interferon production by draining lymph node cells. Moreover, the effect was absent in IL-4-knockout mice. The biological activity in the LaE was not mediated by amphiphilic molecules and was inhibited by pretreatment of the extract with irreversible serine protease inhibitors. These findings indicate that the LaE contains a virulence-related factor that (i) enhances the Leishmania infection by promoting Th2-type immune responses, (ii) is not one of the immunomodulatory Leishmania molecules described so far, and (iii) is either a serine protease or has an effect that depends on that protease activity. In addition to being Leishmania species specific, the infection-enhancing activity was also shown to depend on the host genetic makeup, as LaE injections did not affect the susceptibility of C57BL/6 mice to L. braziliensis infection. The identification of Leishmania molecules with infection-enhancing activity could be important for the development of a vaccine, since the up- or downmodulation of the immune response against a virulence factor could well contribute to controlling the infection