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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.

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 severe inflammatory reaction that occurs after brain death (BD) tends to amplify over time contributing to cardiovascular deterioration and occurrence of cardiac arrest (CA). Our purpose is to evaluate the effect of BD protocol duration (BDPD) on potential donor losses due to CA Methods This retrospective analysis included potential donors reported during the period from May 2012 to April 2014. The risk of losses due to CA was analyzed to identify the chronological threshold at which the probability of loss due to CA increases Results 384 potential donors were analyzed. There was a greater chance of CA after a 30-hour threshold (OR 1.67, 95% CI: 1.38-1.83), and the lowest risk of was identified for the range from 12 to 30 hours (OR 0.32, 95% CI: 0.19-0.52). Multivariate analysis identified the following variables as being associated with CA: BDPD between 12 and 30 hours, management of a potential donor outside the intensive care unit (ICU) and the adherence to a goal-directed protocol Conclusion A long duration between the first clinical test for BD diagnosis and the procurement of organs may be an important risk factor for the occurrence of cardiac arrest in deceased potential donors. This article is protected by copyright. All rights reserved.

RESUMO O transplante de órgãos é a única alternativa para muitos pacientes portadores de algumas doenças terminais. Ao mesmo tempo, é preocupante a crescente desproporção entre a alta demanda por transplantes de órgãos e o baixo índice de transplantes efetivados. Dentre as diferentes causas que alimentam essa desproporção, estão os equívocos na identificação do potencial doador de órgãos e as contraindicações mal atribuídas pela equipe assistente. Assim, o presente documento pretende fornecer subsídios à equipe multiprofissional da terapia intensiva para o reconhecimento, a avaliação e a validação do potencial doador de órgãos. ABSTRACT Organ transplantation is the only alternative for many patients with terminal diseases. The increasing disproportion between the high demand for organ transplants and the low rate of transplants actually performed is worrisome. Some of the causes of this disproportion are errors in the identification of potential organ donors and in the determination of contraindications by the attending staff. Therefore, the aim of the present document is to provide guidelines for intensive care multi-professional staffs for the recognition, assessment and acceptance of potential organ donors.

Background The disproportion between the large organ demand and the low number of transplantations performed represents a serious public health problem worldwide. Reducing the loss of transplantable organs from deceased potential donors as a function of cardiac arrest (CA) may contribute to an increase in organ donations. Our purpose was to test the hypothesis that a goal-directed protocol to guide the management of deceased donors may reduce the losses of potential brain-dead donors (PBDDs) due to CA. Methods The quality improvement project included 27 hospitals that reported deceased donors prospectively to the Transplant Center of the State of Santa Catarina, Brazil. All deceased donors reported prospectively between May 2012 and April 2014 were analyzed. Hospitals were encouraged to use the VIP approach checklist during the management of PBDDs. The checklist was composed of the following goals: protocol duration 12–24 hours, temperature > 35 °C, mean arterial pressure ≥ 65 mmHg, diuresis 1–4 ml/kg/h, corticosteroids, vasopressin, tidal volume 6–8 ml/kg, positive end-expiratory pressure 8–10 cmH2O, sodium

The disproportion between the large organ demand and the low number of transplantations performed represents a serious public health problem worldwide. In Brazil, the loss of transplantable organs from deceased potential donors as a function of cardiac arrest is notably high.

A morte encefálica induz várias alterações fisiopatológicas que podem causar lesões em rins, pulmões, coração e fígado. Portanto, a atuação do intensivista durante a manutenção do potencial doador falecido exige cuidados específicos com estes órgãos visando sua maior viabilidade para transplantes. O manejo hemodinâmico cuidadoso, os cuidados ventilatórios e de higiene brônquica minimizam a perda de rins e pulmões para o transplante. A avaliação da condição morfológica e funcional do coração auxilia na avaliação do potencial transplantável deste órgão. Por fim, a avaliação da função hepática, assim como o controle metabólico e a realização de sorologias virais são fundamentais para a orientação das equipes transplantadoras na seleção do órgão a ser doado e no cuidado com o receptor. Brain death (BD) alters the pathophysiology of patients and may damage the kidneys, the lungs, the heart and the liver. To obtain better quality transplant organs, intensive care physicians in charge of the maintenance of deceased donors should attentively monitor these organs. Careful hemodynamic, ventilatory and bronchial clearance management minimizes the loss of kidneys and lungs. The evaluation of cardiac function and morphology supports the transplant viability assessment of the heart. The monitoring of liver function, the management of the patient's metabolic status and the evaluation of viral serology are fundamental for organ selection by the transplant teams and for the care of the transplant recipient

A atuacao do intensivista durante a manutencao do potencial doador falecido na busca da reducao de perdas de doadores e do aumento da efetivacao de transplantes nao se restringe aos aspectos hemodinâmicos. O adequado controle endocrino-metabolico e essencial para a manutencao do aporte energetico aos tecidos e do controle hidro-eletrolitico, favorecendo inclusive a estabilidade hemodinâmica. A abordagem das alteracoes hematologicas e igualmente importante considerando as implicacoes da pratica transfusional inapropriada. Ressalta-se ainda o papel da ventilacao protetora na modulacao inflamatoria e consequente aumento do aproveitamento de pulmoes para transplante. Por fim, assinala-se a relevância da avaliacao criteriosa das evidencias de atividade infecciosa e da antibioticoterapia na busca do maior utilizacao de orgaos de potenciais doadores falecidos

A desproporção entre a grande demanda por transplantes de órgãos e a baixa realização de transplantes é um grave problema de saúde pública. O reconhecimento da morte encefálica, a adequada abordagem da família e a manutenção clínica do doador falecido são fundamentais para a diminuição desta desproporção. Neste cenário, o intensivista tem importância central e a aplicação do conjunto de informações disponíveis para manutenção do potencial doador falecido está claramente associada à redução de perdas de doadores e ao aumento da qualidade e da efetivação de transplantes There is a relative shortage of appropriate organs available for transplantation. The appropriate diagnosis of brain death, a suitable family approach and the maintenance of the deceased donor are fundamental in addressing this issue. The intensive care physician plays a key role in the maintenance of the deceased donor, thereby reducing losses and increasing the number of successful transplants

Introduction Consistent data about the incidence and outcome of sepsis in Latin American intensive care units (ICUs), including Brazil, are lacking. This study was designed to verify the actual incidence density and outcome of sepsis in Brazilian ICUs. We also assessed the association between the Consensus Conference criteria and outcome