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.

THE SOCIOECONOMIC AND DEMOGRAPHIC CHARACTERIZATION OF CHILDREN AND ADOLESCENTS WHO STUDY AND WORK OUTSIDE THEIR HOME

The objective of this study was to identify the socioeconomic and demographic characteristics of children and adolescents who study and work outside their home. This non-experimental, correlational, cross-sectional study was performed using questionnaires applied to primary education students, enrolled in public schools in Ribeirao Preto (Brazil). Two schools were selected through a draw. Data analysis was performed using Statistical Package for Social Sciences, version 14.0. Of the 133 students who answered the questionnaire, 36 (27.7%) reported working outside their home, 20.6% were between 11 and 13 years of age, and 66.7% were male (p=0.000) and had started working early to help with the family income (p=0.003). The salary they received helped comprise the family income, and it was found that as the family income increased, the need for the youngsters to work was reduced. It was found that many factors contribute to these subjects' early start at work, including family size, structure and poverty.

Simultaneous Quantification of Lycopene, beta-Carotene, Retinol and alpha-Tocopherol in Plasma after a Simple Extraction Procedure: Stability Study and Application to Human Volunteers

A method for the simultaneous quantification of lycopene, beta-carotene, retinol and alpha-tocopherol by high-performance liquid chromatography (HPLC) with Vis/fluorescence detection with isocratic elution was optimized and validated. The method consists of a rapid and simple liquid-liquid extraction procedure and a posterior quantification of extracted supernatants by HPLC. Aliquots of plasma were stored at -20 degrees C for three months for stability study. The methodology was applied to samples from painters and individuals not exposed to paints (n = 75). The assay was linear for all vitamins (r > 0.99). Intra-and inter-run precisions were obtained with coefficient of variation smaller than 5%. The accuracies ranged from 0.29 to -5.80% and recoveries between 92.73 and 101.97%. Plasma samples and extracted supernatants were stable for 60 days at -20 degrees C. A significant decrease of lycopene, beta-carotene and retinol concentrations in plasma from exposed individuals compared to non-exposed individuals (p < 0.05) was observed. The method is simple, reproducible, precise, accurate and sensitive, and can be routinely utilized in clinical laboratories.

Depletion study and estimation of the withdrawal period for oxytetracycline in tilapia cultured in Brazil

Defining pharmacokinetic parameters and depletion intervals for antimicrobials used in fish represents important guidelines for future regulation by Brazilian agencies of the use of these substances in fish farming. This article presents a depletion study for oxytetracycline (OTC) in tilapias (Orechromis niloticus) farmed under tropical conditions during the winter season. High performance liquid chromatography, with fluorescence detection for the quantitation of OTC in tilapia fillets and medicated feed, was developed and validated. The depletion study with fish was carried out under monitored environmental conditions. OTC was administered in the feed for five consecutive days at daily dosages of 80 mg/kg body weight. Groups of ten fish were slaughtered at 1, 2, 3, 4, 5, 8, 10, 15, 20, and 25 days after medication. After the 8th day posttreatment, OTC concentrations in the tilapia fillets were below the limit of quantitation (13 ng/g) of the method. Linear regression of the mathematical model of data analysis presented a coefficient of 0.9962. The elimination half- life for OTC in tilapia fillet and the withdrawal period were 1.65 and 6 days, respectively, considering a percentile of 99% with 95% of confidence and a maximum residue limit of 100 ng/g. Even though the study was carried out in the winter under practical conditions where water temperature varied, the results obtained are similar to others from studies conducted under controlled temperature.

Comparative study and characterization of starches isolated from unconventional tuber sources

Some properties of canna (Canna indica L.) and bore (Alocasia macrorrhiza) starches were evaluated and compared using cassava starch (Manihot esculenta Crantz) as a reference. Proximate analysis, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), Fourier transform infrared spectroscopy (FTIR), X-ray diffraction (XRD) and viscosity measurements were performed. Canna and bore starches showed a similar degree of purity as that of the cassava starch. Canna starch exhibited higher thermal stability and viscosity of solution values than those of bore and cassava starches. XRD spectra showed that canna starch crystallizes as a B-type structure; however, bore and cassava starches crystallize as an A-type structure. Results proved that canna and bore starches are promising bio(materials), obtained from unconventional sources, to be used for industrial applications, as their physicochemical properties are similar to those of cassava starch, which it is known has potential applications in this area.

Simultaneous quantification of lycopene, β-carotene, retinol and α -tocopherol in plasma after a simple extraction procedure: stability study and application to human volunteers

A method for the simultaneous quantification of lycopene, β-carotene, retinol and α-tocopherol by high-performance liquid chromatography (HPLC) with Vis/fluorescence detection with isocratic elution was optimized and validated. The method consists of a rapid and simple liquid-liquid extraction procedure and a posterior quantification of extracted supernatants by HPLC. Aliquots of plasma were stored at -20°C for three months for stability study. The methodology was applied to samples from painters and individuals not exposed to paints (n = 75). The assay was linear for all vitamins (r > 0.99). Intra- and inter-run precisions were obtained with coefficient of variation smaller than 5%. The accuracies ranged from 0.29 to -5.80% and recoveries between 92.73 and 101.97%. Plasma samples and extracted supernatants were stable for 60 days at -20°C. A significant decrease of lycopene, β-carotene and retinol concentrations in plasma from exposed individuals compared to non-exposed individuals (p < 0.05) was observed. The method is simple, reproducible, precise, accurate and sensitive, and can be routinely utilized in clinical laboratories.