RISCO DE DOENÇA TROMBOLÍTICAS APÓS O USO DE ALGESTONA ACETOFENIDA E ENANTATO DE ESTRADIOL

Muitos estudos tem demonstrado que há um risco acentuado de doenças trombolíticas, que podem ser agravadas com predisposições a obesidade, fatores genéticos, fumantes e entre outros. No entanto, estes riscos não são, normalmente citados antes do uso métodos contraceptivos hormonais. Sendo assim, muitas mulheres estão expostas a riscos graves a saúde durante o uso de contraceptivos hormonais. Logo, o intuito do nosso estudo foi avaliar uso prolongado da substância algestona acetofenida e enantato de estradiol sobre o ciclo menstrual de fêmeas cativas de Sapajus libidinosus (macaco-prego). Para tal, foram usadas 06 fêmeas adultas de macaco-prego mantidas no Centro de Primatologia da Universidade de Brasília CP/UnB. Para fins experimentais, as fêmeas receberam uma dose única de 0,10 ml do contraceptivo injetável, que foi administrado a cada 21 dias. Sendo assim, cada fêmea recebeu 05 administrações de contraceptivo consecutivas. Também foram realizadas 12 coletas de sanguíneas de cada fêmea, por meio deste material biológico foram analisados os fatores de coagulação sanguínea, por exemplos, número de plaquetas, fibrinogênio e tempos de protrombina (TP) e tromboplastina (TTPa). Os resultados obtidos permitiram identificar que houve alterações nos fatores de coagulação sanguínea, pois foi registrado um aumento no número de plaquetas (F1,61=450.92; p<0.05) e redução nos tempos de TP (F1,61=91.77; p<0.001) e TTPa (F1,61=42.94; p<0.001). Diante disso é possível mencionar que o contraceptivo administrado nas fêmeas de macaco-prego promoveu alterações nos parâmetros fisiológicos, que são relacionados nos fatores de coagulação. Neste sentido, as fêmeas de macaco-prego podem ser um modelo animal importante, para estudos sobre o tema na medida em que os resultados aqui obtidos demonstram que, fisiologicamente, elas apresentam alterações semelhantes àquelas, que também são encontradas nas mulheres usuárias de contraceptivo hormonal combinado

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

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