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To evaluate factors affecting corneal endothelial cell density (ECD) under enucleation and preservation time studies at Eye Bank of the Federal District of Brazil. We conducted a case–control study collecting data from 1128 corneas where death-to-enucleation time and enucleation-to-preservation time were within 24 h. Low cell count were those corneas with an ECD less than 2000 cells/mm2 and high cell count was defined as those with ECD greater than 2000 cells/mm2. We calculated the independent risk factors related to: cause of death, donor age, death-to-enucleation time, enucleation-to-preservation time and primary graft failure. Correlation analysis was used to assess which parameters influence ECD: death-to-enucleation time, enucleation-to-preservation time, average cell area (AVE), coefficient of variation and percentage of hexagonal cells. Of the total number of corneas, 1004 had ECD data and were selected for the study. 87.4% (n = 877) had high cell counts with 2699 ± 412 cells/mm2. The mean donor age was 38.8 ± 16 years. The most common causes of death were external causes (48.6%, n = 488). Longer times from death-to-enucleation, up to 24 h were not associated with a decrease in ECD (OR 0.58; P = 0.44) or risk of graft survival (P = 0.74). Enucleation-to-preservation intervals greater than 12 h showed increased risk of graft survival (P = 0.04). AVE was the main parameter for ECD (R2 = 0.96, P

RESUMO Objetivo: Fornecer recomendações para nortear o manejo clínico do potencial doador em morte encefálica. Métodos: O presente documento foi formulado em dois painéis compostos por uma força tarefa integrada por 27 especialistas de diferentes áreas que responderam a questões dirigidas aos seguintes temas: ventilação mecânica, hemodinâmica, suporte endócrino-metabólico, infecção, temperatura corporal, transfusão sanguínea, e uso de checklists. Os desfechos considerados foram: parada cardíaca, número de órgãos retirados ou transplantados e função/sobrevida dos órgãos transplantados. A qualidade das evidências das recomendações foi avaliada pelo sistema Grading of Recommendations Assessment, Development, and Evaluation. Resultados: Foram geradas 19 recomendações a partir do painel de especialistas. Dessas, 7 foram classificadas como fortes, 11 fracas e uma foi considerada boa prática clínica. Conclusão: Apesar da concordância entre os membros do painel em relação à maior parte das recomendações, o grau de recomendação é fraco em sua maioria. Abstract Objective: To contribute to updating the recommendations for brain-dead potential organ donor management. Methods: A group of 27 experts, including intensivists, transplant coordinators, transplant surgeons, and epidemiologists, answered questions related to the following topics were divided into mechanical ventilation, hemodynamics, endocrine-metabolic management, infection, body temperature, blood transfusion, and checklists use. The outcomes considered were cardiac arrests, number of organs removed or transplanted as well as function / survival of transplanted organs. The quality of evidence of the recommendations was assessed using the Grading of Recommendations Assessment, Development, and Evaluation system to classify the recommendations. Results: A total of 19 recommendations were drawn from the expert panel. Of these, 7 were classified as strong, 11 as weak and 1 was considered a good clinical practice. Conclusion: Despite the agreement among panel members on most recommendations, the grade of recommendation was mostly weak.

Background: The effectiveness of evidence-based, goal-directed care to reduce losses of brain-dead potential organ donors through cardiac arrest is unclear. DONORS aimed to determine whether guiding clinical management with an evidence-based goal-directed checklist can reduce losses of potential organ donors to cardiac arrest. Methods: This open cluster randomized trial assigned adult intensive care units from hospitals across Brazil with 10 or more annual brain death reports to guide the management of potential donors with the checklist (intervention group) or to maintain usual care without the checklist (control group). Intervention group was instructed to apply a checklist with 13 clinical goals and 14 corresponding actions, every six hours, from study enrollment to organ retrieval. Consecutive potential donors between 14 and 90 years of age were included. Primary outcome was incidence of loss of brain-dead potential organ donors to cardiac arrest at the individual level. A prespecified sensitivity analysis assessed checklist adherence as an effect modifier. Findings: Among 1771 potential donors screened, 1535 were included from 63 hospitals: 31 assigned to checklist guidance (743 potential donors) and 32 to usual care (792 potential donors). Seventy (9.4%) potential donors at intervention hospitals and 117 (14.8%) at control met the primary outcome (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.53 to 1.05; P=0.09). Median checklist adherence was 79% (interquartile range, 64% to 90%). Among those with adherence greater than 79%, primary outcome rate was lower than control group (5.3% vs. 14.8%; HR, 0.45; 9% CI, 0.26 to 0.75). Among those with low adherence, primary outcome rate was comparable to the control group. Interpretation: Overall use of the checklist in preventing donor loss due to cardiac arrest was inconclusive. However, predefined subgroup analysis suggests that high adherence to the checklist may reduce donor losses to cardiac arrest. Funding: Brazilian Ministry of Health through PROADI-SUS. Declaration of Interests: The authors have no conflicts of interest to disclose. Ethics Approval Statement: In accordance with ethical principles stated in the Resolution No. 466/2012 of the Brazilian National Health Council/Ministry of Health, the Research Ethics Committee of each participating hospital approved the conduct of this study with a waiver of consent for eligible potential donors. Trial Registration: ClinicalTrials.gov number, NCT03179020 (https://clinicaltrials.gov/ct2/show/NCT03179020)

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.

Objective To contribute to updating the recommendations for brain-dead potential organ donor management. Method A group of 27 experts, including intensivists, transplant coordinators, transplant surgeons, and epidemiologists, joined a task force formed by the General Coordination Office of the National Transplant System/Brazilian Ministry of Health (CGSNT-MS), the Brazilian Association of Intensive Care Medicine (AMIB), the Brazilian Association of Organ Transplantation (ABTO), and the Brazilian Research in Intensive Care Network (BRICNet). The questions were developed within the scope of the 2011 Brazilian Guidelines for Management of Adult Potential Multiple-Organ Deceased Donors. The topics were divided into mechanical ventilation, hemodynamic support, endocrine-metabolic management, infection, body temperature, blood transfusion, and use of checklists. The outcomes considered for decision-making were cardiac arrest, number of organs recovered or transplanted per donor, and graft function/survival. Rapid systematic reviews were conducted, and the quality of evidence of the recommendations was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Two expert panels were held in November 2016 and February 2017 to classify the recommendations. A systematic review update was performed in June 2020, and the recommendations were reviewed through a Delphi process with the panelists between June and July 2020. Results A total of 19 recommendations were drawn from the expert panel. Of these, 7 were classified as strong (lung-protective ventilation strategy, vasopressors and combining arginine vasopressin to control blood pressure, antidiuretic hormones to control polyuria, serum potassium and magnesium control, and antibiotic use), 11 as weak (alveolar recruitment maneuvers, low-dose dopamine, low-dose corticosteroids, thyroid hormones, glycemic and serum sodium control, nutritional support, body temperature control or hypothermia, red blood cell transfusion, and goal-directed protocols), and 1 was considered a good clinical practice (volemic expansion). Conclusion Despite the agreement among panel members on most recommendations, the grade of recommendation was mostly weak. The observed lack of robust evidence on the topic highlights the importance of the present guideline to improve the management of brain-dead potential organ donors.

To evaluate factors affecting corneal endothelial cell density (ECD) under enucleation and preservation time studies at Eye Bank of the Federal District of Brazil. We conducted a case-control study collecting data from 1128 corneas where death-to-enucleation time and enucleation-to-preservation time were within 24 h. Low cell count were those corneas with an ECD less than 2000 cells/mm