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

Variables associated with the post-treatment healing of lesions in patients with American cutaneous leishmaniasis in Paraná State, Brazil

The purpose of this study was to investigate the relationship of several variables to the healing of lesions in patients with American cutaneous leishmaniasis (ACL). The patients with clinical and/or laboratorial diagnoses of the disease were followed up for varying periods after treatment by clinical evaluation and indirect immunofluorescence assay (IFA), from September 2000 to December 2003. The lesions of 85.3% of the 163 patients had healed by their last return for clinical evaluation, and of these, 82.7% had negative IFA results, indicating an association between the healing of lesions and IFA negativity (p=0.000). In patients evaluated up to 120 days after treatment, there was a significant association between negative IFA results and the healing of lesions (p=0.0000). Logistic regression analysis showed that negative IFA results on patients' first return after treatment predicted a 2.175 fold greater chance of lesion healing (p=0.0001). These results indicate an association between IFA negativity at the first return up to a period of 120 days, and the healing of lesions, and that the chances of healing are significantly higher in patients with negative IFA results at their first return after treatment.<br>O objetivo deste estudo foi investigar a associação de algumas variáveis para a cicatrização de lesões em pacientes com leishmaniose tegumentar americana (LTA). Os pacientes com diagnóstico clínico e laboratorial foram acompanhados depois do tratamento por avaliação clínica e reação de imunofluorescência indireta (IFI), de setembro de 2000 a dezembro de 2003. Dos 163 pacientes 85,3% apresentaram cicatrização das lesões no último retorno para a avaliação clínica e 82,7% destes tiveram a IFI negativa indicando uma associação entre a cicatrização das lesões e a negativação da IFI (p=0,000). Nos pacientes acompanhados até 120 dias depois do tratamento houve associação significativa entre os resultados negativos da IFI e a cicatrização das lesões (p=0,0000). A análise pela regressão logística mostrou que quando a IFI do primeiro retorno após o tratamento foi negativa, o paciente tinha 2,175 mais chance de cicatrização (p=0,0001). Os resultados mostram associação entre a negativação da IFI e a cicatrização das lesões quando o primeiro retorno foi até 120 dias e que as chances de cicatrização são significativamente maiores nos pacientes que apresentaram IFI negativa no primeiro retorno depois do tratamento