Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation.

BACKGROUND: Kidney transplantation is the optimal treatment for kidney failure. Donation, transport and transplant of kidney grafts leads to significant ischaemia reperfusion injury. Static cold storage (SCS), whereby the kidney is stored on ice after removal from the donor until the time of implantation, represents the simplest preservation method. However, technology is now available to perfuse or "pump" the kidney during the transport phase ("continuous") or at the recipient centre ("end-ischaemic"). This can be done at a variety of temperatures and using different perfusates. The effectiveness of these treatments manifests as improved kidney function post-transplant. OBJECTIVES: To compare machine perfusion (MP) technologies (hypothermic machine perfusion (HMP) and (sub) normothermic machine perfusion (NMP)) with each other and with standard SCS. SEARCH METHODS: We contacted the information specialist and searched the Cochrane Kidney and Transplant Register of Studies until 15 June 2024 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov. SELECTION CRITERIA: All randomised controlled trials (RCTs) and quasi-RCTs comparing machine perfusion techniques with each other or versus SCS for deceased donor kidney transplantation were eligible for inclusion. All donor types were included (donor after circulatory death (DCD) and brainstem death (DBD), standard and extended/expanded criteria donors). Both paired and unpaired studies were eligible for inclusion. DATA COLLECTION AND ANALYSIS: The results of the literature search were screened, and a standard data extraction form was used to collect data. Both of these steps were performed by two independent authors. Dichotomous outcome results were expressed as risk ratios (RR) with 95% confidence intervals (CI). Survival analyses (time-to-event) were performed with the generic inverse variance meta-analysis of hazard ratios (HR). Continuous scales of measurement were expressed as a mean difference (MD). Random effects models were used for data analysis. The primary outcome was the incidence of delayed graft function (DGF). Secondary outcomes included graft survival, incidence of primary non-function (PNF), DGF duration, economic implications, graft function, patient survival and incidence of acute rejection. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. MAIN RESULTS: Twenty-two studies (4007 participants) were included. The risk of bias was generally low across all studies and bias domains. The majority of the evidence compared non-oxygenated HMP with standard SCS (19 studies). The use of non-oxygenated HMP reduces the rate of DGF compared to SCS (16 studies, 3078 participants: RR 0.78, 95% CI 0.69 to 0.88; P < 0.0001; I2 = 31%; high certainty evidence). Subgroup analysis revealed that continuous (from donor hospital to implanting centre) HMP reduces DGF (high certainty evidence). In contrast, this benefit over SCS was not seen when non-oxygenated HMP was not performed continuously (low certainty evidence). Non-oxygenated HMP reduces DGF in both DCD and DBD settings in studies performed in the 'modern era' and when cold ischaemia times (CIT) were short. The number of perfusions required to prevent one episode of DGF was 7.69 and 12.5 in DCD and DBD grafts, respectively. Continuous non-oxygenated HMP versus SCS also improves one-year graft survival (3 studies, 1056 participants: HR 0.46, 0.29 to 0.75; P = 0.002; I2 = 0%; high certainty evidence). Assessing graft survival at maximal follow-up confirmed a benefit of continuous non-oxygenated HMP over SCS (4 studies, 1124 participants (follow-up 1 to 10 years): HR 0.55, 95% CI 0.40 to 0.77; P = 0.0005; I2 = 0%; high certainty evidence). This effect was not seen in studies where HMP was not continuous. The effect of non-oxygenated HMP on our other outcomes (PNF, incidence of acute rejection, patient survival, hospital stay, long-term graft function, duration of DGF) remains uncertain. Studies performing economic analyses suggest that HMP is either cost-saving (USA and European settings) or cost-effective (Brazil). One study investigated continuous oxygenated HMP versus non-oxygenated HMP (low risk of bias in all domains); the simple addition of oxygen during continuous HMP leads to additional benefits over non-oxygenated HMP in DCD donors (> 50 years), including further improvements in graft survival, improved one-year kidney function, and reduced acute rejection. One large, high-quality study investigated end-ischaemic oxygenated HMP versus SCS and found end-ischaemic oxygenated HMP (median machine perfusion time 4.6 hours) demonstrated no benefit compared to SCS. The impact of longer periods of end-ischaemic HMP is unknown. One study investigated NMP versus SCS (low risk of bias in all domains). One hour of end ischaemic NMP did not improve DGF compared with SCS alone. An indirect comparison revealed that continuous non-oxygenated HMP (the most studied intervention) was associated with improved graft survival compared with end-ischaemic NMP (indirect HR 0.31, 95% CI 0.11 to 0.92; P = 0.03). No studies investigated normothermic regional perfusion (NRP) or included any donors undergoing NRP. AUTHORS' CONCLUSIONS: Continuous non-oxygenated HMP is superior to SCS in deceased donor kidney transplantation, reducing DGF, improving graft survival and proving cost-effective. This is true for both DBD and DCD kidneys, both short and long CITs, and remains true in the modern era (studies performed after 2008). In DCD donors (> 50 years), the simple addition of oxygen to continuous HMP further improves graft survival, kidney function and acute rejection rate compared to non-oxygenated HMP. Timing of HMP is important, and benefits have not been demonstrated with short periods (median 4.6 hours) of end-ischaemic HMP. End-ischaemic NMP (one hour) does not confer meaningful benefits over SCS alone and is inferior to continuous HMP in an indirect comparison of graft survival. Further studies assessing NMP for viability assessment and therapeutic delivery are warranted and in progress.

Morphological comparison of the larynx and trachea of Chelonia mydas (Linnaeus, 1758), Caiman yacare (Daudin, 1802) and Caiman latirostris (Daudin, 1802).

The larynx is in the lower respiratory tract and has the function of protecting the airways, controlling, and modulating breathing, assisting the circulatory system, and vocalizing. This study aims to describe the anatomy and histology of the skeleton of the larynx and trachea of the species Chelonia mydas, Caiman yacare and Caiman latirostris. The study was conducted at the Federal University of Espírito Santo (UFES), using nine specimens of Ch. mydas, 20 of Ca. yacare and four of Ca. latirostris. Samples of the larynx and trachea were collected, fixed, and sent for dissection of the structures and subsequent macroscopic analysis. For histology, samples were processed by the routine paraffin embedding method and stained with hematoxylin-eosin and Verhoeff. For the three species, two arytenoid cartilages, a cricoid cartilage, a hyoid apparatus composed of a base and two horns were found. In Ch. mydas, two structures called thyroid wings were observed, not found in crocodilians. The trachea of crocodilians presented incomplete tracheal rings and musculature, while the trachea of Ch. mydas presented complete tracheal rings. Histologically, the entire cartilaginous skeleton of the larynx of the three species, as well as the tracheal rings, are constituted by hyaline cartilage.

Dapagliflozin for Critically Ill Patients With Acute Organ Dysfunction: The DEFENDER Randomized Clinical Trial.

Importance: Sodium-glucose cotransporter 2 (SGLT-2) inhibitors improve outcomes in patients with type 2 diabetes, heart failure, and chronic kidney disease, but their effect on outcomes of critically ill patients with organ failure is unknown. Objective: To determine whether the addition of dapagliflozin, an SGLT-2 inhibitor, to standard intensive care unit (ICU) care improves outcomes in a critically ill population with acute organ dysfunction. Design, Setting, and Participants: Multicenter, randomized, open-label, clinical trial conducted at 22 ICUs in Brazil. Participants with unplanned ICU admission and presenting with at least 1 organ dysfunction (respiratory, cardiovascular, or kidney) were enrolled between November 22, 2022, and August 30, 2023, with follow-up through September 27, 2023. Intervention: Participants were randomized to 10 mg of dapagliflozin (intervention, n = 248) plus standard care or to standard care alone (control, n = 259) for up to 14 days or until ICU discharge, whichever occurred first. Main Outcomes and Measures: The primary outcome was a hierarchical composite of hospital mortality, initiation of kidney replacement therapy, and ICU length of stay through 28 days, analyzed using the win ratio method. Secondary outcomes included the individual components of the hierarchical outcome, duration of organ support-free days, ICU, and hospital stay, assessed using bayesian regression models. Results: Among 507 randomized participants (mean age, 63.9 [SD, 15] years; 46.9%, women), 39.6% had an ICU admission due to suspected infection. The median time from ICU admission to randomization was 1 day (IQR, 0-1). The win ratio for dapagliflozin for the primary outcome was 1.01 (95% CI, 0.90 to 1.13; P = .89). Among all secondary outcomes, the highest probability of benefit found was 0.90 for dapagliflozin regarding use of kidney replacement therapy among 27 patients (10.9%) in the dapagliflozin group vs 39 (15.1%) in the control group. Conclusion and Relevance: The addition of dapagliflozin to standard care for critically ill patients and acute organ dysfunction did not improve clinical outcomes; however, confidence intervals were wide and could not exclude relevant benefits or harms for dapagliflozin. Trial Registration: ClinicalTrials.gov Identifier: NCT05558098.

Redescription of three fossil baleen whale skulls from the Miocene of Portugal reveals new cetotheriid phylogenetic insights.

Cetotheriidae is a family of baleen whales that went nearly extinct during the Pleistocene (excluding Caperea marginata). For a long time, the Cetotheriidae family has been seen as a problematic clade, but in the past two decades there have been various studies trying to resolve the phylogeny of this group. In 1831, Alexandre Vandelli described three cetotheriid skulls, found during a gold exploration at Adiça beach (Portugal). These specimens constituted the first Portuguese vertebrate fossils ever published in the literature. Another skull was added to the "Vandelli skulls" by Jacinto Pedro Gomes, in 1914, during a survey of the Museu Nacional de História Natural collections without giving information on the origin of this skull. In 1941, Remington Kellogg states that one of the original "Vandelli skulls" is no longer present in the Museu Nacional de História Natural collections. Until today, there is no information on how, or exactly when, the fourth skull and one of the original three "Vandelli skulls" appeared and disappeared, respectively. Since their discovery, all the attempts to describe these specimens were not based on direct observations and no comprehensive phylogenetic analysis have included the three skulls. Here we provide a detailed anatomic description, a new phylogenetic analysis and a palaeoecological reconstruction of these specimens, clarifying their relationships within the Cetotheriidae family and fostering the importance of these historical specimens to the modern comprehension of fossil whale evolution. In addition, our results support that Cephalotropis nectus is a valid species with an emended diagnosis. We also concluded that two specimens belong to a new genus, forming two new fossil species (new combinations).

Correction: Redescription of three fossil baleen whale skulls from the Miocene of Portugal reveals new cetotheriid phylogenetic insights.

[This corrects the article DOI: 10.1371/journal.pone.0298658.].

Does Time to Asystole in Donors After Circulatory Death Impact Recipient Outcome in Liver Transplantation?

BACKGROUND: The agonal phase can vary following treatment withdrawal in donor after circulatory death (DCD). There is little evidence to support when procurement teams should stand down in relation to donor time to death (TTD). We assessed what impact TTD had on outcomes following DCD liver transplantation. METHODS: Data were extracted from the UK Transplant Registry on DCD liver transplant recipients from 2006 to 2021. TTD was the time from withdrawal of life-sustaining treatment to asystole, and functional warm ischemia time was the time from donor systolic blood pressure and/or oxygen saturation falling below 50 mm Hg and 70%, respectively, to aortic perfusion. The primary endpoint was 1-y graft survival. Potential predictors were fitted into Cox proportional hazards models. Adjusted restricted cubic spline models were generated to further delineate the relationship between TTD and outcome. RESULTS: One thousand five hundred fifty-eight recipients of a DCD liver graft were included. Median TTD in the entire cohort was 13 min (interquartile range, 9-17 min). Restricted cubic splines revealed that the risk of graft loss was significantly greater when TTD ≤14 min. After 14 min, there was no impact on graft loss. Prolonged hepatectomy time was significantly associated with graft loss (hazard ratio, 1.87; 95% confidence interval, 1.23-2.83; P = 0.003); however, functional warm ischemia time had no impact (hazard ratio, 1.00; 95% confidence interval, 0.44-2.27; P > 0.9). CONCLUSIONS: A very short TTD was associated with increased risk of graft loss, possibly because of such donors being more unstable and/or experiencing brain stem death as well as circulatory death. Expanding the stand down times may increase the utilization of donor livers without significantly impairing graft outcome.

Convolutional neural network misclassification analysis in oral lesions: an error evaluation criterion by image characteristics.

OBJECTIVE: This retrospective study analyzed the errors generated by a convolutional neural network (CNN) when performing automated classification of oral lesions according to their clinical characteristics, seeking to identify patterns in systemic errors in the intermediate layers of the CNN. STUDY DESIGN: A cross-sectional analysis nested in a previous trial in which automated classification by a CNN model of elementary lesions from clinical images of oral lesions was performed. The resulting CNN classification errors formed the dataset for this study. A total of 116 real outputs were identified that diverged from the estimated outputs, representing 7.6% of the total images analyzed by the CNN. RESULTS: The discrepancies between the real and estimated outputs were associated with problems relating to image sharpness, resolution, and focus; human errors; and the impact of data augmentation. CONCLUSIONS: From qualitative analysis of errors in the process of automated classification of clinical images, it was possible to confirm the impact of image quality, as well as identify the strong impact of the data augmentation process. Knowledge of the factors that models evaluate to make decisions can increase confidence in the high classification potential of CNNs.

Prospective, randomized, controlled trial assessing the effects of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome due to community-acquired pneumonia (STAMINA trial): protocol and statistical analysis plan.

BACKGROUND: Driving pressure has been suggested to be the main driver of ventilator-induced lung injury and mortality in observational studies of acute respiratory distress syndrome. Whether a driving pressure-limiting strategy can improve clinical outcomes is unclear. OBJECTIVE: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia. METHODS: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance. OUTCOMES: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide. CONCLUSION: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial.

Prospective, randomized, controlled trial assessing the effects of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome due to community-acquired pneumonia (STAMINA trial): protocol and statistical analysis plan / Estudo randomizado prospectivo e controlado de avaliação dos efeitos de uma estratégia de limitação da driving pressure em pacientes com síndrome do desconforto respiratório agudo devido à pneumonia adquirida na comunidade (estudo STAMINA): protocolo e plano de análise estatística

ABSTRACT Background: Driving pressure has been suggested to be the main driver of ventilator-induced lung injury and mortality in observational studies of acute respiratory distress syndrome. Whether a driving pressure-limiting strategy can improve clinical outcomes is unclear. Objective: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia. Methods: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance. Outcomes: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide. Conclusion: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial.

RESUMO Contexto: Em estudos observacionais sobre a síndrome do desconforto respiratório agudo, sugeriu-se que a driving pressure é o principal fator de lesão pulmonar induzida por ventilador e de mortalidade. Não está claro se uma estratégia de limitação da driving pressure pode melhorar os desfechos clínicos. Objetivo: Descrever o protocolo e o plano de análise estatística que serão usados para testar se uma estratégia de limitação da driving pressure envolvendo a titulação da pressão positiva expiratória final de acordo com a melhor complacência respiratória e a redução do volume corrente é superior a uma estratégia padrão envolvendo o uso da tabela de pressão positiva expiratória final baixa do protocolo ARDSNet, em termos de aumento do número de dias sem ventilador em pacientes com síndrome do desconforto respiratório agudo devido à pneumonia adquirida na comunidade. Métodos: O estudo STAMINA (ventilator STrAtegy for coMmunIty acquired pNeumoniA) é randomizado, multicêntrico e aberto e compara uma estratégia de limitação da driving pressure com a tabela de pressão positiva expiratória final baixa do protocolo ARDSnet em pacientes com síndrome do desconforto respiratório agudo moderada a grave devido à pneumonia adquirida na comunidade internados em unidades de terapia intensiva. Esperamos recrutar 500 pacientes de 20 unidades de terapia intensiva brasileiras e duas colombianas. Eles serão randomizados para um grupo da estratégia de limitação da driving pressure ou para um grupo de estratégia padrão usando a tabela de pressão positiva expiratória final baixa do protocolo ARDSnet. No grupo da estratégia de limitação da driving pressure, a pressão positiva expiratória final será titulada de acordo com a melhor complacência do sistema respiratório. Desfechos: O desfecho primário é o número de dias sem ventilador em 28 dias. Os desfechos secundários são a mortalidade hospitalar e na unidade de terapia intensiva e a necessidade de terapias de resgate, como suporte de vida extracorpóreo, manobras de recrutamento e óxido nítrico inalado. Conclusão: O STAMINA foi projetado para fornecer evidências sobre se uma estratégia de limitação da driving pressure é superior à estratégia da tabela de pressão positiva expiratória final baixa do protocolo ARDSnet para aumentar o número de dias sem ventilador em 28 dias em pacientes com síndrome do desconforto respiratório agudo moderada a grave. Aqui, descrevemos a justificativa, o desenho e o status do estudo.

Efeitos da solução balanceada em desfechos de curto prazo em pacientes com traumatismo craniencefálico: uma análise secundária do ensaio clínico randomizado BaSICS / Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial

RESUMO Objetivo: Descrever os efeitos do uso de soluções balanceadas nos desfechos de curto prazo de pacientes com traumatismo craniencefálico incluídos no estudo BaSICS. Métodos: Os pacientes foram randomizados para receber solução salina 0,9% ou solução balanceada durante a internação em unidade de terapia intensiva. O desfecho primário foi mortalidade em 90 dias, já os desfechos secundários foram dias de vida e sem internação em unidade de terapia intensiva aos 28 dias. O desfecho primário foi avaliado por regressão logística bayesiana. O desfecho secundário foi avaliado usando regressão beta-binomial inflada de zeros bayesiana. Resultados: Incluímos 483 pacientes (236 no braço de solução salina 0,9% e 247 no braço de solução balanceada). Foram incluídos 338 pacientes (70%) com pontuação na escala de coma de Glasgow ≤ 12. A probabilidade geral de que soluções balanceadas estivessem associadas a maior mortalidade em 90 dias foi de 0,98 (RC de 1,48; ICr95% 1,04 - 2,09). Esse aumento de mortalidade foi particularmente perceptível em pacientes com pontuação na escala de coma de Glasgow abaixo de 6 no momento da inclusão (probabilidade de dano de 0,99). Soluções balanceadas foram associadas a -1,64 dia de vida e sem internação em unidade de terapia intensiva aos 28 dias (ICr95% -3,32 - 0,00) com probabilidade de dano de 0,97. Conclusão: Houve alta probabilidade de que soluções balanceadas estivessem associadas a alta mortalidade em 90 dias, menos dias de vida e sem internação em unidade de terapia intensiva aos 28 dias. ClinicalTrials.gov:NCT02875873

ABSTRACT Objective: To describe the effects of balanced solution use on the short-term outcomes of patients with traumatic brain injury enrolled in BaSICS trial. Methods: Patients were randomized to receive either 0.9% saline or balanced solution during their intensive care unit stay. The primary endpoint was 90-day mortality, and the secondary outcomes were days alive and free of intensive care unit stay at 28 days. The primary endpoint was assessed using Bayesian logistic regression. The secondary endpoint was assessed using a Bayesian zero-inflated beta binomial regression. Results: We included 483 patients (236 in the 0.9% saline arm and 247 in the balanced solution arm). A total of 338 patients (70%) with a Glasgow coma scale score ≤ 12 were enrolled. The overall probability that balanced solutions were associated with higher 90-day mortality was 0.98 (OR 1.48; 95%CrI 1.04 - 2.09); this mortality increment was particularly noticeable in patients with a Glasgow coma scale score below 6 at enrollment (probability of harm of 0.99). Balanced solutions were associated with -1.64 days alive and free of intensive care unit at 28 days (95%CrI -3.32 - 0.00) with a probability of harm of 0.97. Conclusion: There was a high probability that balanced solutions were associated with high 90-day mortality and fewer days alive and free of intensive care units at 28 days. ClinicalTrials.gov:NCT02875873

IMPACTO-MR: um estudo brasileiro de plataforma nacional para avaliar infecções e multirresistência em unidades de terapia intensiva / IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units

RESUMO Objetivo: Descrever o IMPACTO-MR, um estudo brasileiro de plataforma nacional em unidades de terapia intensiva focado no impacto das infecções por bactérias multirresistentes relacionadas à assistência à saúde. Métodos: Descrevemos a plataforma IMPACTO-MR, seu desenvolvimento, critérios para seleção das unidades de terapia intensiva, caracterização da coleta de dados, objetivos e projetos de pesquisa futuros a serem realizados na plataforma. Resultados: Os dados principais foram coletados por meio do Epimed Monitor System® e consistiram em dados demográficos, dados de comorbidades, estado funcional, escores clínicos, diagnóstico de internação e diagnósticos secundários, dados laboratoriais, clínicos e microbiológicos e suporte de órgãos durante a internação na unidade de terapia intensiva, entre outros. De outubro de 2019 a dezembro de 2020, 33.983 pacientes de 51 unidades de terapia intensiva foram incluídos no banco de dados principal. Conclusão: A plataforma IMPACTO-MR é um banco de dados clínico brasileiro de unidades de terapia intensiva focado na pesquisa do impacto das infecções por bactérias multirresistentes relacionadas à assistência à saúde. Essa plataforma fornece dados para o desenvolvimento e pesquisa de unidades de terapia intensiva individuais e ensaios clínicos observacionais e prospectivos multicêntricos.

ABSTRACT Objective: To describe the IMPACTO-MR, a Brazilian nationwide intensive care unit platform study focused on the impact of health care-associated infections due to multidrug-resistant bacteria. Methods: We described the IMPACTO-MR platform, its development, criteria for intensive care unit selection, characterization of core data collection, objectives, and future research projects to be held within the platform. Results: The core data were collected using the Epimed Monitor System® and consisted of demographic data, comorbidity data, functional status, clinical scores, admission diagnosis and secondary diagnoses, laboratory, clinical, and microbiological data, and organ support during intensive care unit stay, among others. From October 2019 to December 2020, 33,983 patients from 51 intensive care units were included in the core database. Conclusion: The IMPACTO-MR platform is a nationwide Brazilian intensive care unit clinical database focused on researching the impact of health care-associated infections due to multidrug-resistant bacteria. This platform provides data for individual intensive care unit development and research and multicenter observational and prospective trials.

Plano de análise estatística para o estudo Balanced Solution versus Saline in Intensive Care Study (BaSICS) / Statistical analysis plan for the Balanced Solution versus Saline in Intensive Care Study (BaSICS)

RESUMO Objetivo: Relatar o plano de análise estatística (primeira versão) para o estudo Balanced Solutions versus Saline in Intensive Care Study (BaSICS). Métodos: O estudo BaSICS é um ensaio multicêntrico fatorial e randomizado que avaliará os efeitos da administração dos fluidos Plasma-Lyte 148 em comparação com solução salina 0,9% como fluido de escolha em pacientes críticos, assim como os efeitos de uma velocidade de infusão lenta (333mL/hora) em comparação com uma velocidade de infusão rápida (999mL/hora) durante desafios com volume, em importantes desfechos do paciente. O tipo de fluido será mantido cego para os investigadores, pacientes e nas análises. Não será possível, entretanto, ocultar dos investigadores a velocidade de infusão, mas os procedimentos de análise serão mantidos cegos quanto a esse aspecto. Resultados: O estudo BaSICS terá como parâmetro primário a mortalidade em 90 dias, que será testada com utilização de modelos de risco proporcional de Cox de efeitos mistos, considerando os centros de estudo como variável randômica (modelos de fragilidade) ajustada por idade, disfunção de órgãos e tipo de admissão. Os parâmetros secundários importantes incluem terapia de substituição renal até 90 dias, insuficiência renal aguda, disfunção de órgãos nos dias 3 e 7 e dias sem ventilação mecânica em 28 dias. Conclusão: Este artigo fornece detalhes referentes à primeira versão do plano de análise estatística para o estudo BaSICS e orientará a análise do estudo após a conclusão do seguimento.

Abstract Objective: To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS). Methods: BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure. Results: BaSICS will have 90-day mortality as its primary endpoint, which will be tested using mixed-effects Cox proportional hazard models, considering sites as a random variable (frailty models) adjusted for age, organ dysfunction and admission type. Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days. Conclusion: This manuscript provides details on the first version of the statistical analysis plan for the BaSICS trial and will guide the study's analysis when follow-up is finished.

Psychoactive substances and sexually transmitted infections among military police officers from central- western, brazil / Substâncias psicoativas e infecções sexualmente transmissíveis em servidores da força policial do centro-oeste, Brasil

The aim of this work was to evaluate the profile of military police officers regarding the use of psychoactive substances and the presence of Sexually Transmitted Infections (STI). Cross-sectional study carried out with military police officers in 2015 in the central-western, Brazil. The ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) questionnaire was applied to investigate the use of psychoactive substances and serology was performed for syphilis, viral B and C hepatitis and HIV. Cronbach's alpha and Pearson Correlation Coefficient were employed. The ASSIST presented alpha coefficients of Cronbach almost perfect for tobacco (α=0.83) and substantial for the use of alcohol (α=0.70). Of 657 police officers, 78.5% consumed psychoactive substances at some point in their lives, with 76.7% alcohol, 28.5% tobacco, and 5.2% illegal psychoactive substances. A short intervention was required for 23.3% of police officers who used psychoactive substances, and 1.4% should be referred for treatment. Tobacco use was strongly associated with the use of more than one psychoactive substances in life (φ=0.9327), and the use of marijuana showed a moderate correlation with cocaine/crack (φ=0.5241). The prevalence of STI was 14.0%, being 7.6% for HBV, 6.8% syphilis, 0.5% HIV, and 0.3% HCV. HBV/syphilis and HBV/HIV co-infection were observed in 1.1% and 0.1%, respectively. There was no correlation between STI and use of psychoactive substances. The prevalence of HBV and syphilis was higher among police officers than in the general population. The ASSIST questionnaire was consistent when applied to this group and can be a significant tool for monitoring and decision making for timely intervention.

O objetivo deste trabalho foi avaliar o perfil dos policiais militares quanto ao uso de substâncias psicoativas e a presença de Infecções Sexualmente Transmissíveis (IST). Estudo transversalrealizado com policiais militares em 2015 no centro-oeste do Brasil. O questionário ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) foi aplicado para investigar o uso de substâncias psicoativas e foi realizada sorologia para sífilis, Hepatites virais, B e C ,e HIV. O alfa de Cronbach e o coeficiente de correlação de Pearson foram empregados. O ASSIST apresentou coeficientes alfa de Cronbach quase perfeitos para o tabaco (α=0,83) e substancial para o uso de álcool (α=0,70). Dos 657 policiais, 78,5% usaram alguma substância psicoativa em algum momento da vida, sendo 76,7% álcool, 28,5% tabaco e 5,2% substâncias ilícitas. Uma intervenção breve foi necessária para 23,3% dos policiais que usavam substâncias psicoativas, e 1,4% deveriam ser encaminhados para tratamento. O uso de tabaco foi fortemente associado ao uso de mais de uma substância psicoativa na vida (φ=0,9327), e o uso de maconha mostrou uma correlação moderada com a cocaína/crack (φ=0,5241). A prevalência de IST foi de 14,0%, sendo 7,6% para HBV, 6,8% sífilis, 0,5% HIV e 0,3% HCV. A coinfecção HBV/sífilis e HBV/HIV foi observada em 1,1% e 0,1%, respectivamente. Não houve correlação entre IST e uso de substâncias psicoativas. A prevalência de HBV e sífilis foi maior entre policiais do que na população geral. O questionário ASSIST mostrou-se consistente quando aplicado a este grupo e pode ser uma ferramenta importante para monitoramento e tomada de decisão para intervenção oportuna.

Fotogrametria na identificação de assimetrias posturais em cadetes e pilotos da academia da força aérea brasileira / Photogrammetry on the identification of postural asymmetries in cadets and pilots of the Brazilian air force academy

OBJETIVO: Identificar se a atividade de treino de voo pode desencadear alterações posturais em cadetes e pilotos da Academia da Força Aérea Brasileira (AFA). MÉTODOS: Os sujeitos foram avaliados por meio de registro fotográfico em vista anterior e lateral direita, tendo como casuística 80 cadetes da AFA, divididos em quatro grupos, 20 em cada, e 15 pilotos do Esquadrão de Demonstração Aérea (EDA), formando o quinto grupo. As fotos foram transferidas para o Software de Avaliação Postural (SAPO), sendo traçados ângulos relacionados ao alinhamento vertical da cabeça (AVC), alinhamento horizontal da cabeça (AHC), alinhamento horizontal dos acrômios (AHA) e alinhamento horizontal das espinhas ilíacas ântero-superiores (AHE). RESULTADOS: Os resultados mostraram que, após comparação das médias das assimetrias posturais entre os grupos, não houve diferença estatisticamente significante em relação aos ângulos AVC, AHC e AHA. No entanto, na variável AHE, observou-se que o grupo de pilotos apresentou valores significativamente menores que os dos cadetes, sugerindo maior estabilidade postural em relação a essa variável. CONCLUSÃO: O AHE foi a única medida que apresentou diferença estatisticamente significate na comparação entre os pilotos e cadetes dos diferentes anos. Quanto aos demais alinhamentos, não houve diferença, podendo atribuir esse fato aos critérios exigentes de ingresso dos cadetes na AFA e a eficiência do treinamento físico realizado periodicamente.

OBJECTIVE: To identify whether flight training activities cause postural changes in cadets and pilots of the Brazilian Air Force Academy (AFA). METHODS: Eighty subjects were assessed through photographic images in anterior and right side views. Four groups of cadets (n=20 per group) divided according to the year since enlistment and a fifth group of fifteen pilots from the Air Demonstration Squadron (ADS) were included. Pictures were analyzed using the Postural Analysis Program (SAPO) and angles related to head vertical alignment (HVA), head horizontal alignment (HHA), acromion horizontal alignment (AHA) and anterior-superior iliac spine horizontal alignment (HAS) were plotted. RESULTS: We did not find statistical significant differences in the angles: HVA, HHA and AHA. However, a significant difference was found for the HAS angle with pilots having lower values than cadets, suggesting greater postural stability for this variable in pilots. CONCLUSION: The horizontal alignment of the anterior-superior iliac spine was the only measure that showed significant difference in the comparison between pilots and cadets. The remaining alignments were not different, possibility because of the strict criteria used for admission of cadets at the AFA and the efficiency of the physical training that is performed periodically.

On a new peirosaurid crocodyliform from the Upper Cretaceous, Bauru Group, southeastern Brazil

A new crocodyliform from the Upper Cretaceous (Campanian-Maastrichtian) Presidente Prudente Formation of the Bauru Group is described based on two almost complete skulls and mandibles. The material comes from the "Tartaruguito" site, situated at an old railroad between the cities of Pirapozinho and Presidente Prudente, state of São Paulo, Brazil. The new species, Pepesuchus deiseae gen. et sp. nov., is classified in the clade Peirosauridae on the basis of three synapomorphies: the presence of five premaxillary teeth, the anterior two premaxillary alveoli nearly confluent, and the oval cross-section of the jugal along the lower temporal bar. The new taxon increases the outstanding crocodyliform diversity of the Bauru Group, particularly of the Peirosauridae, which might turn out to be one of the most representative clades of gondwanan mesoeucrocodylians.

Um novo crocodilomorfo da Formação Presidente Prudente, Cretáceo Superior (Campaniano-Maastrichtiano) do Grupo Bauru é descrito com base em dois exemplares, consistindo de crânio e mandíbulas quase completos. O material é procedente da localidade conhecida como "Tartaruguito", situada em um antigo ramal ferroviário que ligava as cidades de Pirapozinho e Presidente Prudente, Estado de São Paulo, Brasil. A nova espécie, denominada de Pepesuchus deiseae gen. et sp. nov., é classificada no clado Peirosauridae, com base em três sinapomorfias: presença de cinco dentes pré-maxilares, os dois primeiros alvéolos da pré-maxila quase confluentes e a secção transversal do jugal ao longo da barra temporal inferior oval. O novo táxon aumenta a marcante diversidade de crocodiliformes do Grupo Bauru e dos Peirosauridae, que poderá vir a ser um dos clados mais representativos de mesoeucrocodilianos gondwânicos.