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

Higher incidence of Zika in adult women than adult men in Rio de Janeiro suggests a significant contribution of sexual transmission from men to women

Submitted by Éder Freyre ([email protected]) on 2016-11-30T12:34:49Z No. of bitstreams: 1 va_Flavio_Coelho_etal_Presidencia_2016.pdf: 1480880 bytes, checksum: 04ec4b8aeec2a13453bf8bcfbaf57da6 (MD5)Submitted by Éder Freyre ([email protected]) on 2016-11-30T12:37:57Z No. of bitstreams: 1 va_Flavio_Coelho_etal_Presidencia_2016.pdf: 1480880 bytes, checksum: 04ec4b8aeec2a13453bf8bcfbaf57da6 (MD5)Submitted by Éder Freyre ([email protected]) on 2016-11-30T12:41:06Z No. of bitstreams: 1 va_Flavio_Coelho_etal_Presidencia_2016.pdf: 1480880 bytes, checksum: 04ec4b8aeec2a13453bf8bcfbaf57da6 (MD5)Approved for entry into archive by Claudete Fernandes ([email protected]) on 2016-11-30T12:44:38Z (GMT) No. of bitstreams: 1 va_Flavio_Coelho_etal_Presidencia_2016.pdf: 1480880 bytes, checksum: 04ec4b8aeec2a13453bf8bcfbaf57da6 (MD5)Made available in DSpace on 2016-11-30T12:44:38Z (GMT). No. of bitstreams: 1 va_Flavio_Coelho_etal_Presidencia_2016.pdf: 1480880 bytes, checksum: 04ec4b8aeec2a13453bf8bcfbaf57da6 (MD5) Previous issue date: 2016Fundação Getúlio Vargas. Rio de Janeiro, RJ, Brasil.Prefeitura do Rio de Janeiro. Secretaria Municipal de Saúde. Rio de Janeiro, RJ, Brasil.Prefeitura do Rio de Janeiro. Secretaria Municipal de Saúde. Rio de Janeiro, RJ, Brasil.Prefeitura do Rio de Janeiro. Secretaria Municipal de Saúde. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Programa de Computação Científica. Rio de Janeiro, RJ, Brasil.Fundação Getúlio Vargas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Programa de Computação Científica. Rio de Janeiro, RJ, Brasil.Fundação Getúlio Vargas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Programa de Computação Científica. Rio de Janeiro, RJ, Brasil / University of Edinburgh. Institute of Evolutionary Biology, Edinburgh, UK.Fundação Oswaldo Cruz. Presidência. Programa de Computação Científica. Rio de Janeiro, RJ, Brasil.Prefeitura do Rio de Janeiro. Secretaria Municipal de Saúde. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Presidência. Programa de Computação Científica. Rio de Janeiro, RJ, Brasil.Fundação Getúlio Vargas. Rio de Janeiro, RJ, Brasil / MINES Paristech. PSL Research University. CERNA Centre for Industrial Economy. Paris, France.The recent emergence of Zika in Brazil and its association with an increased rate of congenital malformations has raised concerns over its impact on the birth rate in the country. Using data on the incidence of Zika in 2015-2016 and dengue in 2013 and 2015-2016 for the city of Rio de Janeiro (population 6.4 million), a massive increase of Zika in women compared to men was documented.Objectives: The recent emergence of Zika in Brazil and its association with an increased rate of congenital malformations has raised concerns over its impact on the birth rate in the country. Using data on the incidence of Zika in 2015–2016 and dengue in 2013 and 2015–2016 for the city of Rio de Janeiro (population 6.4 million), a massive increase of Zika in women compared to men was documented. Methods: The age-adjusted incidence was compared between men and women. A negative binomial Poisson generalized linear model was fitted to the Zika incidence data to determine the significance of sexual transmission statistically. Results: Even after correcting for the bias due to the systematic testing of pregnant women for Zika, there were found to be 90% more registered cases per 100 000 women than men in the sexually active age group (15–65 years); this was not the case for age groups 65 years. Assuming that infected men transmit the disease to women in their semen, but that the converse is not true, some extra incidence in women is to be expected. An alternate hypothesis would be that women visit doctors more often than men. To test this, the incidence of dengue fever was compared in men and women in 2015 and in 2013 (before Zika reached Rio de Janeiro): in both years, women were 30% more likely to be reported with dengue. Conclusion: Women in the sexually active age group are far more likely to get Zika than men (+90% increase); sexual transmission is the most probable cause. Women in the 15–65 years age group are also 30% more likely to be reported with dengue than men, which is probably due to women being more careful with their health

Neurologic manifestations in emerging arboviral diseases in Rio de Janeiro City, Brazil, 2015-2016

Abstract INTRODUCTION Dengue has affected Rio de Janeiro City since the 1980s. The sequential Zika and chikungunya virus introductions during 2015 aggravated the health scenario, with 97,241 cases of arboviral diseases reported in 2015-2016, some with neurological disorders. METHODS Arbovirus-related neurologic cases were descriptively analyzed, including neurological syndromes and laboratory results. RESULTS In total, 112 cases with non-congenital neurologic manifestations (Guillain-Barré syndrome, 64.3%; meningoencephalitis, 24.1%; acute demyelinating encephalomyelitis, 8%) were arbovirus-related; 43.7% were laboratory-confirmed, of which 57.1% were chikungunya-positive. CONCLUSIONS Emerging arbovirus infections brought opportunities to study atypical, severe manifestations. Surveillance responses optimized case identification and better clinical approaches

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