IntroductionThere is an increasing demand for multi-organ donors for organ transplantation programmes. This study protocol describes the Donation Network to Optimise Organ Recovery Study, a planned cluster randomised controlled trial that aims to evaluate the effectiveness of the implementation of an evidence-based, goal-directed checklist for brain-dead potential organ donor management in intensive care units (ICUs) in reducing the loss of potential donors due to cardiac arrest.Methods and analysisThe study will include ICUs of at least 60 Brazilian sites with an average of ≥10 annual notifications of valid potential organ donors. Hospitals will be randomly assigned (with a 1:1 allocation ratio) to the intervention group, which will involve the implementation of an evidence-based, goal-directed checklist for potential organ donor maintenance, or the control group, which will maintain the usual care practices of the ICU. Team members from all participating ICUs will receive training on how to conduct family interviews for organ donation. The primary outcome will be loss of potential donors due to cardiac arrest. Secondary outcomes will include the number of actual organ donors and the number of organs recovered per actual donor.Ethics and disseminationThe institutional review board (IRB) of the coordinating centre and of each participating site individually approved the study. We requested a waiver of informed consent for the IRB of each site. Study results will be disseminated to the general medical community through publications in peer-reviewed medical journals.Trial registration numberNCT03179020; Pre-results.
Background
The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest.
Methods/design
The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care). The primary outcome is loss of potential donors due to cardiac arrest. Secondary outcomes are the number of actual organ donors and the number of solid organs recovered per actual donor. Exploratory outcomes include the achievement of relevant clinical goals during the management of brain-dead potential organ donors. The present statistical analysis plan (SAP) describes all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of the trial.
Discussion
The SAP of the DONORS study aims to describe its analytic procedures, enhancing the transparency of the study. At the moment of SAP subsmission, 63 institutions have been randomised and were enrolling study participants. Thus, the analyses reported herein have been defined before the end of the study recruitment and database locking.
Trial registration
ClinicalTrials.gov, NCT03179020. Registered on 7 June 2017.
Introduction: Hepatocellular carcinoma is one of the most frequent types of malignant tumors in the world. There is growing evidence of the relationship between it development and obesity. The mechanism that links obesity to cancer is still not fully understood; however, it is essential to the understanding the adipose tissue in metabolic changes related to obesity and hepatocellular carcinoma. Objective: To review the influence of serum leptin levels in patients with hepatocelular carcinoma. Method: Systematic review of the literature based on the methodology of the Cochrane Institute. The search for articles was in the database: Science Direct, Scielo, Medline, Lilacs e Pubmed. The key words used were hepatocellular carcinoma, leptin, adipokine. Results: After evaluation of individual studies, were selected seven studies. The results previously studied are still inconsistent and contradictory, and leptin can be effectively involved in the occurrence and development of hepatocellular carcinoma. Conclusion: Therefore, it is necessary to develop prospective, well-designed and conducted focusing on the role and specific mechanisms of this hormone in patients with hepatocellular carcinoma, so that new correlations can be properly supported.
Recurrent aphthous stomatitis (RAS) is the most prevalent oral lesion in the mouth (Akintoye & Greenberg, 2005). It is important for human health due to the associated pain and compromised quality of life (Brocklehurst et al., 2012). The etiology of this condition remains unclear (Edgar et al., 2017), despite studies that have evaluated the possible association of RAS with a large range of risk factors.Smoking appears as a protective factor, while young age and female gender are reported risk factors (Tüzün et al., 2000).The association of Helicobacter pylori with RAS has been evaluated. Beyond the stomach, where this bacterium is typically found,
O objetivo deste trabalho é avaliar a influência da vitamina D no tratamento de hepatite C com interferon alfa peguilado e ribavirina. Foram utilizados artigos científicos relevantes publicados entre os anos de 2000 e 2015. Diversos estudos abrangidos observaram que níveis mais elevados de vitamina D estavam associados à rápida resposta ao tratamento e maior taxa de RVS, sugerindo que a deficiência de vitamina D pode estar ligada a uma falta de resposta ao tratamento antiviral. A influência do polimorfismo do gene IL28B em associação com a vitamina D também foi avaliada. Os estudos observaram que a vitamina D e o polimorfismo do gene IL28B são indicadores que agem de forma independente para o alcance da RVS. Quando avaliados, os estudos com suplementação de vitamina D observaram maior taxa de RVS para pacientes que receberam suplementação se comparados com os pacientes que só utilizaram a terapia convencional, demonstrando que a vitamina D pode ter um impacto positivo na eficácia do tratamento tanto em pacientes com genótipo de difícil resposta como nos genótipos de melhor prognóstico. Entretanto, os mecanismos de ação pelos quais a vitamina D e seus metabólitos aumentam a eficácia da terapia anti HCV e a RVS ainda não estão completamente claros. A alta prevalência de deficiência de vitamina D associada à baixa resposta ao tratamento e a alta RVS em pacientes que apresentam níveis séricos mais elevados de vitamina D demonstram que a vitamina D é um indicador independente fortemente associado à RVS.
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