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.

Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial.

Importance: The effectiveness of goal-directed care to reduce loss of brain-dead potential donors to cardiac arrest is unclear. Objective: To evaluate the effectiveness of an evidence-based, goal-directed checklist in the clinical management of brain-dead potential donors in the intensive care unit (ICU). Design, Setting, and Participants: The Donation Network to Optimize Organ Recovery Study (DONORS) was an open-label, parallel-group cluster randomized clinical trial in Brazil. Enrollment and follow-up were conducted from June 20, 2017, to November 30, 2019. Hospital ICUs that reported 10 or more brain deaths in the previous 2 years were included. Consecutive brain-dead potential donors in the ICU aged 14 to 90 years with a condition consistent with brain death after the first clinical examination were enrolled. Participants were randomized to either the intervention group or the control group. The intention-to-treat data analysis was conducted from June 15 to August 30, 2020. Interventions: Hospital staff in the intervention group were instructed to administer to brain-dead potential donors in the intervention group an evidence-based checklist with 13 clinical goals and 14 corresponding actions to guide care, every 6 hours, from study enrollment to organ retrieval. The control group provided or received usual care. Main Outcomes and Measures: The primary outcome was loss of brain-dead potential donors to cardiac arrest at the individual level. A prespecified sensitivity analysis assessed the effect of adherence to the checklist in the intervention group. Results: Among the 1771 brain-dead potential donors screened in 63 hospitals, 1535 were included. These patients included 673 males (59.2%) and had a median (IQR) age of 51 (36.3-62.0) years. The main cause of brain injury was stroke (877 [57.1%]), followed by trauma (485 [31.6%]). Of the 63 hospitals, 31 (49.2%) were assigned to the intervention group (743 [48.4%] brain-dead potential donors) and 32 (50.8%) to the control group (792 [51.6%] brain-dead potential donors). Seventy potential donors (9.4%) at intervention hospitals and 117 (14.8%) at control hospitals met the primary outcome (risk ratio [RR], 0.70; 95% CI, 0.46-1.08; P = .11). The primary outcome rate was lower in those with adherence higher than 79.0% than in the control group (5.3% vs 14.8%; RR, 0.41; 95% CI, 0.22-0.78; P = .006). Conclusions and Relevance: This cluster randomized clinical trial was inconclusive in determining whether the overall use of an evidence-based, goal-directed checklist reduced brain-dead potential donor loss to cardiac arrest. The findings suggest that use of such a checklist has limited effectiveness without adherence to the actions recommended in this checklist. Trial Registration: ClinicalTrials.gov Identifier: NCT03179020.

Erratum: Evaluation of the characteristics of infection prevention and control programs and infection control committees in Brazilian hospitals: A countrywide cross-sectional study - CORRIGENDUM.

[This corrects the article DOI: 10.1017/ash.2023.136.].

Evaluation of the characteristics of infection prevention and control programs and infection control committees in Brazilian hospitals: A countrywide cross-sectional study.

Objective: Data are scarce regarding hospital infection control committees and compliance with infection prevention and control (IPC) recommendations in Brazil, a country of continental dimensions. We assessed the main characteristics of infection control committees (ICCs) on healthcare-associated infections (HAIs) in Brazilian hospitals. Methods: This cross-sectional study was conducted in ICCs of public and private hospitals distributed across all Brazilian regions. Data were collected directly from the ICC staff by completing an online questionnaire and during on-site visits through face-to-face interviews. Results: In total, 53 Brazilian hospitals were evaluated from October 2019 to December 2020. All hospitals had implemented the IPC core components in their programs. All centers had protocols for the prevention and control of ventilator-associated pneumonia as well as bloodstream, surgical site, and catheter-associated urinary tract infections. Most hospitals (80%) had no budget specifically allocated to the IPC program; 34% of the laundry staff had received specific IPC training; and only 7.5% of hospitals reported occupational infections in healthcare workers. Conclusions: In this sample, most ICCs complied with the minimum requirements for IPC programs. The main limitation regarding ICCs was the lack of financial support. The findings of this survey support the development of strategic plans to improve IPCs in Brazilian hospitals.

Risk factors for hospital mortality in intensive care unit survivors: a retrospective cohort study.

BACKGROUND: Deaths can occur after a patient has survived treatment for a serious illness in an intensive care unit (ICU). Mortality rates after leaving the ICU can be considered indicators of health care quality. This study aims to describe risk factors and mortality of surviving patients discharged from an ICU in a university hospital. METHODS: Retrospective cohort study carried out from January 2017 to December 2018. Data on age, sex, length of hospital stay, diagnosis on admission to the ICU, hospital discharge outcome, presence of infection, and Simplified Acute Physiology Score (SAPS) III prognostic score were collected. Infected patients were considered as those being treated for an infection on discharge from the ICU. Patients were divided into survivors and non-survivors on leaving the hospital. The association between the studied variables was performed using the logistic regression model. RESULTS: A total of 1,025 patients who survived hospitalization in the ICU were analyzed, of which 212 (20.7%) died after leaving the ICU. When separating the groups of survivors and non-survivors according to hospital outcome, the median age was higher among non-survivors. Longer hospital stays and higher SAPS III values were observed among non-survivors. In the logistic regression, the variables age, length of hospital stay, SAPS III, presence of infection, and readmission to the ICU were associated with hospital mortality. CONCLUSIONS: Infection on ICU discharge, ICU readmission, age, length of hospital stay, and SAPS III increased risk of death in ICU survivors.

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.

Recusa de leitos e triagem de pacientes admitidos nas unidades de terapia intensiva do Brasil: estudo transversal do tipo survey nacional / Refusal of beds and triage of patients admitted to intensive care units in Brazil: a cross-sectional national survey

RESUMO Objetivo: Conhecer dados sobre recusa de leitos nas unidades intensivas no Brasil, assim como avaliar o uso de sistemas de triagem pelos profissionais atuantes. Métodos: Estudo transversal do tipo survey. Com a metodologia Delphi, foi criado um questionário contemplando os objetivos do trabalho. Foram convidados médicos e enfermeiros inscritos na rede de pesquisa da Associação de Medicina Intensiva Brasileira (AMIBnet). Uma plataforma da web (SurveyMonkey®) foi a forma de aplicação do questionário. As variáveis deste trabalho foram mensuradas em categorias e expressas como proporção. Foram usados o teste do qui-quadrado ou o teste exato de Fisher, para verificar associações. O nível de significância foi de 5%. Resultados: No total, 231 profissionais responderam o questionário, representando todas as regiões do país. As unidades intensivas nacionais tinham mais de 90% de taxa de ocupação sempre ou frequentemente para 90,8% dos participantes. Dentre os participantes, 84,4% já deixaram de admitir pacientes em leito intensivo devido à lotação da unidade. Metade das instituições brasileiras (49,7%) não possuía protocolos de triagem de leitos intensivos instituídos. Conclusão: A recusa de leito pela alta taxa de ocupação é frequente nas unidades de terapia intensiva do Brasil. Ainda assim, metade dos serviços do Brasil não adota protocolos para triagem de leitos.

ABSTRACT Objective: To obtain data on bed refusal in intensive care units in Brazil and to evaluate the use of triage systems by professionals. Methods: A cross-sectional survey. Using the Delphi methodology, a questionnaire was created contemplating the objectives of the study. Physicians and nurses enrolled in the research network of the Associação de Medicina Intensiva Brasileira (AMIBnet) were invited to participate. A web platform (SurveyMonkey®) was used to distribute the questionnaire. The variables in this study were measured in categories and expressed as proportions. The chi-square test or Fisher's exact test was used to verify associations. The significance level was set at 5%. Results: In total, 231 professionals answered the questionnaire, representing all regions of the country. The national intensive care units had an occupancy rate of more than 90% always or frequently for 90.8% of the participants. Among the participants, 84.4% had already refused admitting patients to the intensive care unit due to the capacity of the unit. Half of the Brazilian institutions (49.7%) did not have triage protocols for admission to intensive beds. Conclusions: Bed refusal due to high occupancy rates is common in Brazilian intensive care units. Even so, half of the services in Brazil do not adopt protocols for triage of beds.

Associação entre nível de priorização na admissão da Unidade de Terapia Intensiva e desfecho hospitalar / Association between prioritization level at intensive care unit admission and hospital outcome

Objetivo: avaliar a associação entre os níveis de priorização para admissão na Unidade de Terapia Intensiva (UTI) e o prognóstico dos pacientes. Material e Método: estudo longitudinal retrospectivo que incluiu adultos internados na UTI de hospital universitário, ano de 2020. As variáveis, coletadas nos prontuários e banco de dados eletrônicos do hospital contemplam: identificação, data de entrada no hospital e de admissão na UTI, diagnósticos, antecedentes, data de alta, desfecho, cálculo do Simplified Acute Physiology Score 3 (SAPS 3) e nível de priorização da admissão. Resultados: o estudo avaliou 274 pacientes. As patologias respiratórias totalizaram 41,25% das admissões, sendo COVID-19 o diagnóstico mais frequente (65 casos confirmados e 2 suspeitos). Dentre as comorbidades, destacam-se hipertensão arterial sistêmica (64,32%), diabetes mellitus (25,82%) e tabagismo (18,78%). O SAPS 3 médio foi de 59,29 pontos, representando uma probabilidade de óbito de 39,00%. A respeito dos níveis de priorizações, 174 (63,50%) pacientes foram classificados como prioridade 1 (P1); 94 (34,31%) pacientes como prioridade 2 (P2); e 6 (2,19%) pacientes como prioridade 3 (P3). Comparando os grupos P1 e P2, a probabilidade de óbito foi, respectivamente, 51,95% e 13,75%. E o número de óbitos observado foi de 90 (60,81%) no grupo P1 e 19 no grupo P2 (25,30%; p<0,001)). Conclusão: os pacientes classificados como P1 foram mais frequentes na amostra de estudo. A classificação de prioridades identificou os pacientes mais graves e com maior taxa de mortalidade na primeira categoria, apesar de não haver diferença na idade, comorbidade e fragilidade.

Objective: to assess the association between levels of prioritization for admission to intensive care unit (ICU) and patients' prognosis. Material and Method: longitudinal retrospective study that included adult patients admitted to the ICU of a University Hospital during 2020. The data were collected from paper and electronic medical records, including identification, date of admission to the hospital, date of admission to ICU, diagnosis, medical history, date of hospital discharge, outcome, the Simplified Acute Physiology Score 3 (SAPS-3) and prioritization level. Results: the study evaluated 274 patients during 2020. Respiratory diseases represented 41.25% of admissions, COVID-19 being the most frequent diagnosis (totaling 65 confirmed and 2 suspected cases). Among the comorbidities, the following were highlighted: arterial hypertension (64.32%), diabetes mellitus (25.82%), and smoking (18.78%). The mean SAPS 3 score was 59.29 points, representing a probability of death of 39.00%. About prioritization levels, 174 (63.50%) patients were categorized as Priority 1 (P1); 94 (34.31%) patients as Priority 2 (P2) and 6 (2.19%) patients as Priority 3 (P3), which was not considered due to insufficient sample for testing. Comparing groups P1 and P2, the probability of death of each category was, respectively, 51.95% and 13.75%. During the study period, the number of deaths in each category was 90 (60.81%) for P1 and 19 (25.30%; p<0,001) for P2. Conclusion: the prioritization classification identified patients with more severity and with greater mortality rates in category P1 of prioritization to ICU admission, even though there was no difference on age, comorbidity and frailty.

Decreased plasma H2O2 levels are associated with the pathogenesis leading to COVID-19 worsening and mortality.

Oxidative Stress (OS) is involved in the pathogenesis of COVID-19 and in the mechanisms by which SARS-CoV-2 causes injuries to tissues, leading to cytopathic hypoxia and ultimately multiple organ failure. The measurement of blood glutathione (GSH), H2O2, and catalase activity may help clarify the pathophysiology pathways of this disease. We developed and standardized a sensitive and specific chemiluminescence technique for H2O2 and GSH measurement in plasma and red blood cells of COVID-19 patients admitted to the intensive care unit (ICU). Contrary to what was expected, the plasma concentration of H2O2 was substantially reduced (10-fold) in COVID-19 patients compared to the healthy control group. From the cohort of patients discharged from the hospital and those who were deceased, the former showed a 3.6-fold and the later 16-fold H2O2 reduction compared to the healthy control. There was a 4.4 reduction of H2O2 concentration in the deceased group compared to the discharged group. Interestingly, there was no variation in GSH levels between groups, and reduced catalase activity was found in discharged and deceased patients compared to control. These data represent strong evidence that H2O2 is converted into highly reactive oxygen species (ROS), leading to the worst prognosis and death outcome in COVID-19 patients admitted to ICU. Considering the difference in the levels of H2O2 between the control group and the deceased patients, it is proposed the quantification of plasma H2O2 as a marker of disease progression and the induction of the synthesis of antioxidant enzymes as a strategy to reduce the production of oxidative stress during severe COVID-19.HighlightsH2O2 plasma levels is dramatically reduced in patients who deceased compared to those discharged and to the control group.Plasmatic quantification of H2O2 can be possibly used as a predictor of disease progression.Catalase activity is reduced in COVID-19.GSH levels remain unchanged in COVID-19 compared to the control group.

Refusal of beds and triage of patients admitted to intensive care units in Brazil: a cross-sectional national survey. / Recusa de leitos e triagem de pacientes admitidos nas unidades de terapia intensiva do Brasil: estudo transversal do tipo survey nacional.

OBJECTIVE: To obtain data on bed refusal in intensive care units in Brazil and to evaluate the use of triage systems by professionals. METHODS: A cross-sectional survey. Using the Delphi methodology, a questionnaire was created contemplating the objectives of the study. Physicians and nurses enrolled in the research network of the Associação de Medicina Intensiva Brasileira (AMIBnet) were invited to participate. A web platform (SurveyMonkey®) was used to distribute the questionnaire. The variables in this study were measured in categories and expressed as proportions. The chi-square test or Fisher's exact test was used to verify associations. The significance level was set at 5%. RESULTS: In total, 231 professionals answered the questionnaire, representing all regions of the country. The national intensive care units had an occupancy rate of more than 90% always or frequently for 90.8% of the participants. Among the participants, 84.4% had already refused admitting patients to the intensive care unit due to the capacity of the unit. Half of the Brazilian institutions (49.7%) did not have triage protocols for admission to intensive beds. CONCLUSIONS: Bed refusal due to high occupancy rates is common in Brazilian intensive care units. Even so, half of the services in Brazil do not adopt protocols for triage of beds.

OBJETIVO: Conhecer dados sobre recusa de leitos nas unidades intensivas no Brasil, assim como avaliar o uso de sistemas de triagem pelos profissionais atuantes. MÉTODOS: Estudo transversal do tipo survey. Com a metodologia Delphi, foi criado um questionário contemplando os objetivos do trabalho. Foram convidados médicos e enfermeiros inscritos na rede de pesquisa da Associação de Medicina Intensiva Brasileira (AMIBnet). Uma plataforma da web (SurveyMonkey®) foi a forma de aplicação do questionário. As variáveis deste trabalho foram mensuradas em categorias e expressas como proporção. Foram usados o teste do qui-quadrado ou o teste exato de Fisher, para verificar associações. O nível de significância foi de 5%. RESULTADOS: No total, 231 profissionais responderam o questionário, representando todas as regiões do país. As unidades intensivas nacionais tinham mais de 90% de taxa de ocupação sempre ou frequentemente para 90,8% dos participantes. Dentre os participantes, 84,4% já deixaram de admitir pacientes em leito intensivo devido à lotação da unidade. Metade das instituições brasileiras (49,7%) não possuía protocolos de triagem de leitos intensivos instituídos. CONCLUSÃO: A recusa de leito pela alta taxa de ocupação é frequente nas unidades de terapia intensiva do Brasil. Ainda assim, metade dos serviços do Brasil não adota protocolos para triagem de leitos.

Percutaneous Coronary Intervention in Unprotected Left Main Coronary Artery Lesions. / Intervenção Coronariana Percutânea em Lesões não Protegidas de Tronco.

BACKGROUND: The advent of drug-eluting stents allowed the percutaneous coronary intervention to present safe results in lesions in the left main coronary artery. OBJECTIVES: To analyze the results of the percutaneous treatment of unprotected left main coronary artery lesion with the use of intravascular ultrasound. METHODS: Study of consecutive case series carried out from January 2010 to December 2018. Clinical data were collected from patients as well as prognostic scores and data on coronary lesion. Low-grade residual lesion (less than 50%) on angiography and minimum luminal area greater than 6 mm2on intravascular ultrasound were considered successful. The adopted significance level was 5%. RESULTS: 107 cases were analyzed. The multivessel lesion was predominant, with most (39.25%) of the lesions being found in three vessels in addition to the left main coronary artery. The SYNTAX score had a mean of 46.80 (SD: 22.95), and 70 (65.42%) patients had a SYNTAX score above 32 points. Angiographic success of percutaneous intervention was considered in 106 (99.06%) patients. The overall rate of major cardiac and cerebrovascular events in the hospital outcome was 6.54%, being similar in patients with SYNTAX score ≤ 32 (8.10%) and ≥ 33 (5.71%; p = 0.68). CONCLUSIONS: Percutaneous intervention in cases of unprotected left main coronary artery lesion was safely performed and presented excellent results. Considerable angiographic success of treatment guided by intravascular ultrasound was achieved. The rate of major cardiac and cerebrovascular events was similar between patients at low and high risks.

FUNDAMENTO: O advento dos stents farmacológicos permitiu que a intervenção coronariana percutânea apresentasse resultados seguros nas lesões de tronco da artéria coronária esquerda. OBJETIVOS: Analisar os resultados do tratamento percutâneo da lesão não protegida de tronco da artéria coronária com a utilização de ultrassom intravascular. MÉTODOS: Estudo de série de casos consecutivos realizado no período de janeiro de 2010 a dezembro de 2018. Coletaram-se dados clínicos dos pacientes, assim como escores prognósticos e dados da lesão coronariana. Considerou-se de sucesso a lesão residual menor que 50% à angiografia e a área mínima da luz maior que 6 mm 2 ao ultrassom intravascular. O nível de significância adotado foi de 5%. RESULTADOS: Analisaram-se 107 casos. A lesão multiarterial foi predominante, sendo com maior frequência (39,25%) encontradas lesões em três vasos além do tronco coronariano. O escore SYNTAX apresentou média de 46,80 (DP: 22,95), e 70 (65,42%) pacientes tiveram escore SYNTAX acima de 32 pontos. Considerou-se sucesso angiográfico da intervenção percutânea em 106 (99,06%) pacientes. A taxa geral de evento maior cardíaco e cerebrovascular no desfecho hospitalar foi 6,54%, sendo semelhante nos pacientes com escore SYNTAX ≤ 32 (8,10%) e ≥ 33 (5,71%; p = 0,68) . CONCLUSÕES: A intervenção percutânea em casos de lesão não protegida de tronco coronariano foi realizada com segurança e apresentou ótimos resultados. Atingiu-se alto sucesso angiográfico de tratamento guiado pelo ultrassom intravascular. A taxa de eventos cardíacos e cerebrovasculares maiores foi semelhante entre os pacientes de menor e de maior risco.

Managed clinical protocol: impact of implementation on sepsis treatment quality indicators.

OBJECTIVES: to assess the impact of the implementation of a managed sepsis protocol on quality indicators of treatment for septic patients in an emergency department of a university hospital. METHODS: an observational epidemiological study involving septic patients. The study was divided into two phases, pre-intervention and intervention, resulting from the implementation of the managed sepsis protocol. The study variables included sepsis treatment quality indicators. The results were statistically analyzed using the program Epi InfoTM. RESULTS: the study sample included 631 patients, 95 from pre-intervention phase and 536 from intervention phases. Implementing the protocol increased patients' chances of receiving the recommended treatment by 14 times. Implementing the protocol reduced the hospitalization period by 6 days (p <0.001) and decreased mortality (p <0.001). CONCLUSIONS: this study showed that implementing the managed protocol had an impact on the improvement of sepsis treatment quality indicators.

Intervenção Coronariana Percutânea em Lesões não Protegidas de Tronco / Percutaneous Coronary Intervention in Unprotected Left Main Coronary Artery Lesions

Resumo Fundamento O advento dos stents farmacológicos permitiu que a intervenção coronariana percutânea apresentasse resultados seguros nas lesões de tronco da artéria coronária esquerda. Objetivos Analisar os resultados do tratamento percutâneo da lesão não protegida de tronco da artéria coronária com a utilização de ultrassom intravascular. Métodos Estudo de série de casos consecutivos realizado no período de janeiro de 2010 a dezembro de 2018. Coletaram-se dados clínicos dos pacientes, assim como escores prognósticos e dados da lesão coronariana. Considerou-se de sucesso a lesão residual menor que 50% à angiografia e a área mínima da luz maior que 6 mm 2 ao ultrassom intravascular. O nível de significância adotado foi de 5%. Resultados Analisaram-se 107 casos. A lesão multiarterial foi predominante, sendo com maior frequência (39,25%) encontradas lesões em três vasos além do tronco coronariano. O escore SYNTAX apresentou média de 46,80 (DP: 22,95), e 70 (65,42%) pacientes tiveram escore SYNTAX acima de 32 pontos. Considerou-se sucesso angiográfico da intervenção percutânea em 106 (99,06%) pacientes. A taxa geral de evento maior cardíaco e cerebrovascular no desfecho hospitalar foi 6,54%, sendo semelhante nos pacientes com escore SYNTAX ≤ 32 (8,10%) e ≥ 33 (5,71%; p = 0,68) . Conclusões A intervenção percutânea em casos de lesão não protegida de tronco coronariano foi realizada com segurança e apresentou ótimos resultados. Atingiu-se alto sucesso angiográfico de tratamento guiado pelo ultrassom intravascular. A taxa de eventos cardíacos e cerebrovasculares maiores foi semelhante entre os pacientes de menor e de maior risco.

Abstract Background The advent of drug-eluting stents allowed the percutaneous coronary intervention to present safe results in lesions in the left main coronary artery. Objectives To analyze the results of the percutaneous treatment of unprotected left main coronary artery lesion with the use of intravascular ultrasound. Methods Study of consecutive case series carried out from January 2010 to December 2018. Clinical data were collected from patients as well as prognostic scores and data on coronary lesion. Low-grade residual lesion (less than 50%) on angiography and minimum luminal area greater than 6 mm2on intravascular ultrasound were considered successful. The adopted significance level was 5%. Results 107 cases were analyzed. The multivessel lesion was predominant, with most (39.25%) of the lesions being found in three vessels in addition to the left main coronary artery. The SYNTAX score had a mean of 46.80 (SD: 22.95), and 70 (65.42%) patients had a SYNTAX score above 32 points. Angiographic success of percutaneous intervention was considered in 106 (99.06%) patients. The overall rate of major cardiac and cerebrovascular events in the hospital outcome was 6.54%, being similar in patients with SYNTAX score ≤ 32 (8.10%) and ≥ 33 (5.71%; p = 0.68). Conclusions Percutaneous intervention in cases of unprotected left main coronary artery lesion was safely performed and presented excellent results. Considerable angiographic success of treatment guided by intravascular ultrasound was achieved. The rate of major cardiac and cerebrovascular events was similar between patients at low and high risks.

Managed clinical protocol: impact of implementation on sepsis treatment quality indicators / Protocolo clínico gestionado: impacto de la implementación en los indicadores de calidad del tratamiento de la sepsis / Protocolo clínico gerenciado: impacto da implementação nos indicadores de qualidade do tratamento da sepse

ABSTRACT Objectives: to assess the impact of the implementation of a managed sepsis protocol on quality indicators of treatment for septic patients in an emergency department of a university hospital. Methods: an observational epidemiological study involving septic patients. The study was divided into two phases, pre-intervention and intervention, resulting from the implementation of the managed sepsis protocol. The study variables included sepsis treatment quality indicators. The results were statistically analyzed using the program Epi InfoTM. Results: the study sample included 631 patients, 95 from pre-intervention phase and 536 from intervention phases. Implementing the protocol increased patients' chances of receiving the recommended treatment by 14 times. Implementing the protocol reduced the hospitalization period by 6 days (p <0.001) and decreased mortality (p <0.001). Conclusions: this study showed that implementing the managed protocol had an impact on the improvement of sepsis treatment quality indicators.

RESUMEN Objetivos: evaluar el impacto de la implementación de un protocolo de sepsis manejada sobre los indicadores de calidad del tratamiento del paciente séptico en el servicio de urgencia de un hospital universitario. Métodos: estudio epidemiológico observacional con pacientes sépticos. El estudio se dividió en dos fases, preintervención e intervención, resultado de la implementación del protocolo de sepsis manejada. Las variables de estudio incluyeron indicadores de calidad del tratamiento de la sepsis. Los resultados fueron analizados estadísticamente por el programa Epi InfoTM. Resultados: la muestra de estudio incluyó a 631 pacientes, 95 de la fase de preintervención y 536 de la fase de intervención. La implementación del protocolo aumentó 14 veces las posibilidades de que el paciente recibiera el tratamiento recomendado. La implementación del protocolo redujo el período de hospitalización en 6 días (p<0,001) y disminuyó la mortalidad (p<0,001). Conclusiones: el estudio mostró que la implementación del protocolo gestionado incidió en la mejora de los indicadores de calidad en el tratamiento de la sepsis.

RESUMO Objetivos: avaliar o impacto da implementação de protocolo clínico gerenciado de sepse nos indicadores de qualidade do tratamento de pacientes sépticos atendidos em setor de urgência e emergência de um hospital universitário. Métodos: estudo epidemiológico observacional envolvendo pacientes sépticos. O estudo se dividiu em duas fases, pré-intervenção e intervenção, decorrente da implementação do protocolo gerenciado de sepse. As variáveis do estudo contemplaram os indicadores de qualidade do tratamento da sepse. Os resultados foram analisados estatisticamente pelo programa Epi InfoTM. Resultados: a amostra do estudo contemplou 631 pacientes, 95 da fase pré-intervenção e 536 da fase intervenção. A implementação do protocolo aumentou em 14 vezes as chances de o paciente receber o tratamento recomendado. A implementação do protocolo reduziu em 6 dias o período de hospitalização (p<0,001) e diminuiu a mortalidade (p<0,001). Conclusões: o estudo evidenciou que a implementação do protocolo gerenciado impactou na melhoria dos indicadores de qualidade no tratamento da sepse.

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

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.

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.

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.

Non-recovery of renal function is a strong independent risk factor associated with mortality in AKI patients / A não recuperação da função renal é um forte fator de risco independente associado à mortalidade em pacientes com LRA

ABSTRACT Introduction: Acute kidney injury (AKI) is a recurrent complication in the intensive care unit (ICU) and is associated with negative outcomes. Objective: To investigate factors associated with mortality in critically ill AKI patients in a South Brazilian ICU. Methods: The study was observational retrospective involving AKI patients admitted to the ICU between January 2011 and December 2016 of at least 18 years old upon admission and who remained in the ICU at least 48 hours. Comparisons between selected characteristics of survivor and non-survivor groups were done using univariate analysis; multivariate logistic regression was applied to determine factors associated with patient mortality. Results: Of 838 eligible patients, 613 participated in the study. Men represented the majority (61.2%) of the patients, the median age was 53 years, and the global mortality rate was 39.6% (n= 243). Non-recovery of renal function after AKI (OR= 92.7 [38.43 - 223.62]; p <0.001), major surgery-associated AKI diagnosis (OR= 16.22 [3.49 - 75.38]; p <0.001), and the use of vasoactive drugs during the ICU stay (OR = 11.49 [2.46 - 53.70]; p <0.002) were the main factors independently associated with patient mortality. Conclusion: The mortality rate observed in this study was similar to that verified in other centers. Non-recovery of renal function was the variable most strongly associated with patient mortality, suggesting that the prevention of factors that aggravate or maintain the AKI episode should be actively identified and mitigated, possibly constituting an important strategy to reduce mortality in AKI patients.

RESUMO Introdução: A lesão renal aguda (LRA) é uma complicação recorrente na unidade de terapia intensiva (UTI), e está associada a desfechos desfavoráveis. Objetivo: Investigar fatores associados à mortalidade em pacientes com LRA, criticamente enfermos em uma UTI do Sul do Brasil. Métodos: O estudo foi retrospectivo observacional, envolvendo pacientes com LRA internados na UTI entre janeiro de 2011 e dezembro de 2016, com pelo menos 18 anos de idade na admissão e que permaneceram na UTI por pelo menos 48 horas. Comparações entre características selecionadas de grupos sobreviventes e não sobreviventes foram feitas usando análise univariada; regressão logística multivariada foi aplicada para determinar fatores associados à mortalidade dos pacientes. Resultados: Dos 838 pacientes elegíveis, 613 participaram do estudo. Os homens representaram a maioria (61,2%) dos pacientes, a idade média foi de 53 anos e a taxa de mortalidade global foi de 39,6% (n = 243). Não recuperação da função renal após LRA (OR = 92,7 [38,43 - 223,62]; p <0,001), diagnóstico de LRA associado à cirurgia (OR = 16,22 [3,49 - 75,38]; p <0,001) e uso de drogas vasoativas durante a internação na UTI (OR = 11,49 [2,46 - 53,70]; p <0,002) foram os principais fatores independentemente associados à mortalidade dos pacientes. Conclusão: A taxa de mortalidade observada neste estudo foi semelhante à verificada em outros centros. A não recuperação da função renal foi a variável mais fortemente associada à mortalidade dos pacientes, sugerindo que a prevenção de fatores que agravam ou mantêm o episódio de LRA deve ser ativamente buscada e incentivada, possivelmente constituindo uma estratégia importante para reduzir a mortalidade em pacientes com LRA.

Critical incidents as perceived by rapid response teams in emergency services.

OBJECTIVE: To analyze two hospital emergency services, one in a public institution and another in a philanthropic one, from the perspective of rapid response team professionals in the face of positive and negative critical incidents. METHOD: Descriptive, exploratory, qualitative study carried with 62 health professionals. Critical Incident Technique was employed as the theoretical-methodological framework, along with Content Analysis for analyzing data. RESULTS: Sixty-two health professionals - including 23 nurses, 20 physiotherapists and 19 doctors - took part in this study. Clusters for 89 critical incidents were obtained; 66 of them were considered positive, whereas 23 were negative. The situations associated to the provided services were discriminated in three categories: recognition of patient clinical deterioration; rapid response team activation in the unit; and time until rapid response team arrival at the ward. CONCLUSION: In spite of the difficulties faced by such professionals while providing care to patients who become severely ill in non-critical wards, positive reports were predominant in all categories, what legitimized this service's importance as a contribution to quality and safety of hospitalized patients.

Non-recovery of renal function is a strong independent risk factor associated with mortality in AKI patients.

INTRODUCTION: Acute kidney injury (AKI) is a recurrent complication in the intensive care unit (ICU) and is associated with negative outcomes. OBJECTIVE: To investigate factors associated with mortality in critically ill AKI patients in a South Brazilian ICU. METHODS: The study was observational retrospective involving AKI patients admitted to the ICU between January 2011 and December 2016 of at least 18 years old upon admission and who remained in the ICU at least 48 hours. Comparisons between selected characteristics of survivor and non-survivor groups were done using univariate analysis; multivariate logistic regression was applied to determine factors associated with patient mortality. RESULTS: Of 838 eligible patients, 613 participated in the study. Men represented the majority (61.2%) of the patients, the median age was 53 years, and the global mortality rate was 39.6% (n= 243). Non-recovery of renal function after AKI (OR= 92.7 [38.43 - 223.62]; p <0.001), major surgery-associated AKI diagnosis (OR= 16.22 [3.49 - 75.38]; p <0.001), and the use of vasoactive drugs during the ICU stay (OR = 11.49 [2.46 - 53.70]; p <0.002) were the main factors independently associated with patient mortality. CONCLUSION: The mortality rate observed in this study was similar to that verified in other centers. Non-recovery of renal function was the variable most strongly associated with patient mortality, suggesting that the prevention of factors that aggravate or maintain the AKI episode should be actively identified and mitigated, possibly constituting an important strategy to reduce mortality in AKI patients.