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

Corncob and active charcoal in the Laccase and Basidiome production of Pleurotus sp

O sabugo de milho é uma matéria prima lignocelulósica que pode ser uma opção viável para a produção de cogumelos comestíveis por fungos do gênero Pleurotus, considerando-se que existe uma enorme quantidade deste resíduo agrícola no Estado do Paraná e em todo o Brasil. Este trabalho avaliou três linhagens de Pleurotus sp., Pleurotus ostreatus (branco e CCB) e P. Eryngii (Salmão), como produtoras de lacase utilizando-se extrato líquido de sabugo de milho e em meio sólido à base de sabugo de milho, sem adicionar outras fontes de nutrientes. A linhagem de Pleurotus ostreatus (branco) produziu os maiores títulos de lacase no meio líquido (1,2 U L-1) e também no sólido (~ 2,8 U kg-1) dentre as três linhagens avaliadas. A adição de carvão ativo aumentou a eficiência biológica (30,3 %) do P. eryngii (salmão) quando comparada com a ausência do mesmo (12,7 %). Entretanto, a linhagem de P. ostreatus (branco) não apresentou diferença estatística entre os tratamentos, mostrando que a adição de carvão ativo ao meio sólido, para a produção de cogumelos, pode proporcionar um aumento na eficiência biológica, dependendo da linhagem utilizada.Corn cob as a lignocellulosic feedstock could be a viable option for edible mushroom production by fungi of the genus Pleurotus considering that there are enormous amounts of this agricultural waste in the State of Parana, as well in the whole Brazil territory. This work evaluated three strains of Pleurotus sp., Pleurotus ostreatus (white and CCB), P. Eryngii (salmon), as laccase producers using liquid extract of corn cob, and solid medium based on corn cob without adding other nutritional sources. A strain of Pleurotus ostreatus (white) produced the highest titres of laccase in liquid medium (1.2 U L-1) and also on solid medium (~ 2.8 U kg-1) among the three strains evaluated. The additon of active charcoal increased the biological efficency (30.3 %) of P. eryngii (salmon) when compared in its absence (12.7 %). However, the strain of P. ostreatus (white) did not present statistical difference among the treatments demonstrating that the addition of active charcoal to the solid medium for mushroom production can promote an increase in the biological efficiency depending upon the fungal strain used

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.13Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt