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

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

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.

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.

Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care Unit: The ICU Visits Randomized Clinical Trial.

Importance: The effects of intensive care unit (ICU) visiting hours remain uncertain. Objective: To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium. Design, Setting and Participants: Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018. Interventions: Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation. Main Outcomes and Measures: Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory). Results: Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, -1.7% [95% CI, -6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, -0.8% [95% CI, -2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, -3.8% [95% CI, -4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, -1.6 [95% CI, -2.3 to -0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, -1.2 [95% CI, -2.0 to -0.4]; P = .003) were significantly better with flexible visitation. Conclusions and Relevance: Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium. Trial Registration: ClinicalTrials.gov Identifier: NCT02932358.

Rationale and design for a cluster randomized quality improvement trial to increase the uptake of evidence based therapies for patients at high cardiovascular risk: The bridge cardiovascular prevention trial

BACKGROUND: Translating evidence into clinical practice in the management of high cardiovascular risk patients is challenging. Few quality improvement interventions have rigorously evaluated their impact on both patient care and clinical outcomes. OBJECTIVES: The main objectives are to evaluate the impact of a multifaceted educational intervention on adherence to local guidelines for the prescription of statins, antiplatelets and angiotensin converting enzyme inhibitors or angiotensin II receptor blockers for high cardiovascular risk patients, as well as on the incidence of major cardiovascular events. DESIGN: We designed a pragmatic two arm cluster randomized trial involving 40 clusters. Clusters are randomized to receive a multifaceted quality improvement intervention or to routine practice (control). The multifaceted intervention includes: reminders, care algorithms, training of a case manager, audit and feedback reports, and distribution of educational materials to health care providers. The primary endpoint is the adherence to combined evidence-based therapies (statins, antiplatelet therapy and angiotensin converting enzyme inhibitors or angiotensin receptor blockers) at 12 months after the intervention period in patients without contra-indications for these medications. All analyses follow the intention-to-treat principle and take the cluster design into account using linear mixed logistic regression modeling. SUMMARY: If proven effective, this multifaceted intervention would have wide utility as a means of promoting optimal usage of evidence-based interventions for the management of high cardiovascular risk patients. (AU)

Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study).

BACKGROUND: Most adult intensive care units (ICUs) worldwide adopt restrictive family visitation models (RFVMs). However, evidence, mostly from non-randomized studies, suggests that flexible adult ICU visiting hours are safe policies that can result in benefits such as prevention of delirium and increase in satisfaction with care. Accordingly, the ICU Visits Study was designed to compare the effectiveness and safety of a flexible family visitation model (FFVM) vs. an RFVM on delirium prevention among ICU patients, and also to analyze its potential effects on family members and ICU professionals. METHODS/DESIGN: The ICU Visits Study is a cluster-randomized crossover trial which compares an FFVM (12 consecutive ICU visiting hours per day) with an RFVM (< 4.5 ICU visiting hours per day) in 40 Brazilian adult ICUs. Participant ICUs are randomly assigned to either an FFVM or RFVM in a 1:1 ratio. After enrollment and follow-up of 25 patients, each ICU is crossed over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome is the cumulative incidence of delirium measured by the Confusion Assessment Method for the ICU. Secondary and tertiary outcomes include relevant measures of effectiveness and safety of ICU visiting policies among patients, family members, and ICU professionals. Herein, we describe all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of this study. This pre-specified statistical analysis plan was written and submitted without knowledge of the study data. DISCUSSION: This a priori statistical analysis plan aims to enhance the transparency of our study, facilitating unbiased analyses of ICU visit study data, and provide guidance for statistical analysis for groups conducting studies in the same field. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02932358 . Registered on 11 October 2016.

Pulmonary complications after non-cardiac surgeries: temporal patterns and risk factors.

BACKGROUND: Postoperative complications are the primary determinants of survival following major surgery. We aimed to characterize the early perioperative risk factors for postoperative pulmonary complications (POPCs) in patients undergoing major non-cardiac surgeries. METHODS: This study utilized a multicenter prospective observational cohort design. Adult patients undergoing non-cardiac surgeries and admitted to 21 Brazilian ICUs were screened for inclusion in the study. POPCs were defined as the presence of acute pulmonary oedema, nosocomial pneumonia, and extubation failure in the postoperative period. RESULTS: Of the 581 patients enrolled, 110 (19%) had at least one POPC, of whom 5% had acute pulmonary oedema, 10% extubation failure while 10% had pneumonia. Most cases of pulmonary oedema occurred in the first week after surgery, while pneumonia was more frequently a later occurrence. The mortality rate was significantly higher in the group with POPCs compared to the group of patients without POPCs (62% vs. 11%, RR: 5.1, 95% CI: 4.23-7.69; P < 0.001). A low functional capacity (RR: 4.6, 95% CI: 2.1-10.0), major surgery (RR: 3.6, 95% CI: 1.2-10.7), preoperative hemodynamic instability (RR: 3.4, 95% CI: 1.1-10.6), alcoholism (RR: 3.3, 95% CI: 1.0-10.7), unplanned surgery (RR: 2.3, 95% CI: 1.0-5.2), the SOFA score (RR: 1.1, 95% CI: 1.0-1.2), and increased central venous pressure (RR: 1.1, 95% CI: 1.0-1.1) were independent predictors of POPCs. CONCLUSIONS: Pulmonary complications are common in intensive care units after major non-cardiac surgeries. Awareness of the risk factors for POPCs may help multidisciplinary teams develop strategies to prevent these complications.

A cluster randomized trial of a multifaceted quality improvement intervention in Brazilian intensive care units: study protocol.

BACKGROUND: The uptake of evidence-based therapies in the intensive care environment is suboptimal, particularly in limited-resource countries. Checklists, daily goal assessments, and clinician prompts may improve compliance with best practice processes of care and, in turn, improve clinical outcomes. However, the available evidence on the effectiveness of checklists is unreliable and inconclusive, and the mechanisms are poorly understood. We aim to evaluate whether the use of a multifaceted quality improvement intervention, including the use of a checklist and the definition of daily care goals during multidisciplinary daily rounds and clinician prompts, can improve the in-hospital mortality of patients admitted to intensive care units (ICUs). Our secondary objectives are to assess the effects of the study intervention on specific processes of care, clinical outcomes, and the safety culture and to determine which factors (the processes of care and/or safety culture) mediate the effect of the study intervention on mortality. METHODS/DESIGN: This is a cluster randomized trial involving 118 ICUs in Brazil conducted in two phases. In the observational preparatory phase, we collect baseline data on processes of care and clinical outcomes from 60 consecutive patients with lengths of ICU stay longer than 48 h and apply the Safety Attitudes Questionnaire (SAQ) to 75% or more of the health care staff in each ICU. In the randomized phase, we assign ICUs to the experimental or control arm and repeat data collection. Experimental arm ICUs receive the multifaceted quality improvement intervention, including a checklist and definition of daily care goals during daily multidisciplinary rounds, clinician prompting, and feedback on rates of adherence to selected care processes. Control arm ICUs maintain usual care. The primary outcome is in-hospital mortality, truncated at 60 days. Secondary outcomes include the rates of adherence to appropriate care processes, rates of other clinical outcomes, and scores on the SAQ domains. Analysis follows the intention-to-treat principle, and the primary outcome is analyzed using mixed effects logistic regression. DISCUSSION: This is a large scale, pragmatic cluster-randomized trial evaluating whether a multifaceted quality improvement intervention, including checklists applied during the multidisciplinary daily rounds and clinician prompting, can improve the adoption of proven therapies and decrease the mortality of critically ill patients. If this study finds that the intervention reduces mortality, it may be widely adopted in intensive care units, even those in limited-resource settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT01785966.

Percepção dos profissionais sobre o tratamento no fim da vida, nas unidades de terapia intensiva da Argentina, Brasil e Uruguai / Perceptions about end of life treatment in Argentina, Brazil and Uruguay intensive care units

OBJETIVO: Avaliar as condutas tomadas nas Unidades de Terapia Intensiva (UTI) com os pacientes críticos terminais. MÉTODOS: Os membros do grupo de estudo do final da vida das sociedades Argentina, Brasileira e Uruguaia de Terapia Intensiva elaboraram um questionário no qual constavam avaliações demográficas sobre os participantes, sobre as instituições em que os mesmos trabalhavam e decisões sobre limite de esforço terapêutico (LET). Neste estudo de corte transversal os membros da equipe multiprofissional das sociedades responderam o questionário durante eventos científicos e, via on line. As variáveis foram analisadas através do teste qui-quadrado sendo considerado significativa p<0,05. RESULTADOS: Participaram do estudo 420 profissionais. No Brasil as UTI tinham mais leitos, foi mais rara a permissão irrestrita de visitas, os profissionais eram mais jovens, trabalhavam a menos tempo na UTI e houve maior participação de não médicos. Três visitas/dia foi o número mais frequente nos três países. Os fatores que mais influíram nas decisões de LET foram prognóstico da doença, co-morbidades e futilidade terapêutica. Nos três países mais de 90 por cento dos participantes já havia decidido por LET. Reanimação cardiorrespiratória, administração de drogas vaso-ativas, métodos dialíticos e nutrição parenteral foram as terapias mais suspensas/recusadas nos três países. Houve diferença significativa quanto à suspensão da ventilação mecânica, mais frequente na Argentina, seguida do Uruguai. Analgesia e sedação foram as terapias menos suspensas nos três países. Definições legais e éticas foram apontadas como as principais barreiras para a tomada de decisão. CONCLUSÃO: Decisões de LET são frequentemente utilizados entre os profissionais que atuam nas UTI dos três países. Existe uma tendência da ação de LET mais pró-ativa na Argentina, e uma maior equidade na distribuição das decisões no Uruguai. Essa diferença parece estar relacionada às diferenças...

ABSTRACT OBJECTIVE: To evaluate end-of-life procedures in intensive care units. METHODS: A questionnaire was prepared by the End-of-Life Study Group of the Argentinean, Brazilian and Uruguayan Intensive Care societies, collecting data on the participants’ demographics, institutions and limit therapeutic effort (LTE) decision making process. During this cross sectional study, the societies’ multidisciplinary teams members completed the questionnaire either during scientific meetings or online. The variables were analyzed with the Chi-square test, with a p<0.05 significance level. RESULTS: 420 professionals completed the questionnaire. The Brazilian units had more beds, unrestricted visit was less frequent, their professionals were younger and worked more recently in intensive care units, and more non-medical professionals completed the questionnaire. Three visits daily was the more usual number of visits for the three countries. The most influencing LTE factors were prognosis, co-morbidities, and therapeutic futility. In the three countries, more than 90 percent of the completers had already made LTE decisions. Cardiopulmonary resuscitation, vasoactive drugs administration, dialysis and parenteral nutrition were the most suspended/refused therapies in the three countries. Suspension of mechanic ventilation was more frequent in Argentina, followed by Uruguay. Sedation and analgesia were the less suspended therapies in the three countries. Legal definement and ethical issues were mentioned as the main barriers for the LTE decision making process. CONCLUSION: LTE decisions are frequent among the professionals working in the three countries’ intensive care units. We found a more proactive LTE decision making trend In Argentina, and more equity for decisions distribution in Uruguay. This difference appears to be related to the participants’ different ages, experiences, professional types and genders.

Perceptions about end of life treatment in Argentina, Brazil and Uruguay intensive care units. / Percepção dos profissionais sobre o tratamento no fim da vida, nas unidades de terapia intensiva da Argentina, Brasil e Uruguai.

ABSTRACT OBJECTIVE: To evaluate end-of-life procedures in intensive care units. METHODS: A questionnaire was prepared by the End-of-Life Study Group of the Argentinean, Brazilian and Uruguayan Intensive Care societies, collecting data on the participants’ demographics, institutions and limit therapeutic effort (LTE) decision making process. During this cross sectional study, the societies’ multidisciplinary teams members completed the questionnaire either during scientific meetings or online. The variables were analyzed with the Chi-square test, with a p<0.05 significance level. RESULTS: 420 professionals completed the questionnaire. The Brazilian units had more beds, unrestricted visit was less frequent, their professionals were younger and worked more recently in intensive care units, and more non-medical professionals completed the questionnaire. Three visits daily was the more usual number of visits for the three countries. The most influencing LTE factors were prognosis, co-morbidities, and therapeutic futility. In the three countries, more than 90% of the completers had already made LTE decisions. Cardiopulmonary resuscitation, vasoactive drugs administration, dialysis and parenteral nutrition were the most suspended/refused therapies in the three countries. Suspension of mechanic ventilation was more frequent in Argentina, followed by Uruguay. Sedation and analgesia were the less suspended therapies in the three countries. Legal definement and ethical issues were mentioned as the main barriers for the LTE decision making process. CONCLUSION: LTE decisions are frequent among the professionals working in the three countries’ intensive care units. We found a more proactive LTE decision making trend In Argentina, and more equity for decisions distribution in Uruguay. This difference appears to be related to the participants’ different ages, experiences, professional types and genders.

Central venous saturation is a predictor of reintubation in difficult-to-wean patients.

OBJECTIVE: To evaluate the predictive value of central venous saturation to detect extubation failure in difficult-to-wean patients. DESIGN: Cohort, multicentric, clinical study. SETTING: Three medical-surgical intensive care units. PATIENTS: All difficult-to-wean patients (defined as failure to tolerate the first 2-hr T-tube trial), mechanically ventilated for >48 hrs, were extubated after undergoing a two-step weaning protocol (measurements of predictors followed by a T-tube trial). Extubation failure was defined as the need of reintubation within 48 hrs. INTERVENTIONS: The weaning protocol evaluated hemodynamic and ventilation parameters, and arterial and venous gases during mechanical ventilation (immediately before T-tube trial), and at the 30th min of spontaneous breathing trial. MEASUREMENTS AND MAIN RESULTS: Seventy-three patients were enrolled in the study over a 6-mo period. Reintubation rate was 42.5%. Analysis by logistic regression revealed that central venous saturation was the only variable able to discriminate outcome of extubation. Reduction of central venous saturation by >4.5% was an independent predictor of reintubation, with odds ratio of 49.4 (95% confidence interval 12.1-201.5), a sensitivity of 88%, and a specificity of 95%. Reduction of central venous saturation during spontaneous breathing trial was associated with extubation failure and could reflect the increase of respiratory muscles oxygen consumption. CONCLUSIONS: Central venous saturation was an early and independent predictor of extubation failure and may be a valuable accurate parameter to be included in weaning protocols of difficult-to-wean patients.

1º Forum do Grupo de Estudos do Fim da Vida do Cone Sul: proposta para atendimento do paciente portador de doença terminal internado em UTI / 1st Forum of the Southern Cone End-of-Life Study Group: proposal for care of patients, bearers of terminal disease staying in the ICU

As condutas de limitação de tratamento oferecidas a pacientes portadores de doenças terminais, internados em Unidades de Terapia Intensiva, tem aumentado a sua freqüência nos últimos anos em todo o mundo. Apesar disto, ainda existe uma grande dificuldade dos intensivistas brasileiros em oferecer o melhor tratamento àqueles pacientes que não se beneficiariam com terapêuticas curativas. O objetivo deste comentário é apresentar uma sugestão de fluxograma para atendimento de pacientes com doenças terminais que foi elaborado, baseado na literatura e experiência de experts, pelos membros do comitê de ética e de terminalidade da AMIB.

Withholding of treatment in patients with terminal disease is increasingly common in intensive care units, throughout the world. Notwithstanding, Brazilian intensivists still have a great difficulty to offer the best treatment to patients that have not benefited from curative care. The objective of this comment is to suggest an algorithm for the care of terminally ill patients. It was formulated based upon literature and the experience of experts, by members of the ethics committee and end-of-life of AMIB - Brazilian Association of Intensive Care.

1st Forum of the Southern Cone End-of-Life Study Group: proposal for care of patients, bearers of terminal disease staying in the ICU. / 1º Forum do Grupo de Estudos do Fim da Vida do Cone Sul: proposta para atendimento do paciente portador de doença terminal internado em UTI.

Withholding of treatment in patients with terminal disease is increasingly common in intensive care units, throughout the world. Notwithstanding, Brazilian intensivists still have a great difficulty to offer the best treatment to patients that have not benefited from curative care. The objective of this comment is to suggest an algorithm for the care of terminally ill patients. It was formulated based upon literature and the experience of experts, by members of the ethics committee and end-of-life of AMIB - Brazilian Association of Intensive Care.

Terminalidade e cuidados paliativos na unidade de terapia intensiva: [revisão] / End of life and palliative care in intensive care unit: [review]

O objetivo da presente revisão foi avaliar o estado atual do conhecimento sobre doença terminal e cuidados paliativos em unidade de terapia intensiva. Identificar as questões-chave e sugerir uma agenda de pesquisa sobre essas questões. A Associação Brasileira de Medicina Intensiva organizou um fórum especifico para o debate de doenças terminais na unidade de terapia intensiva, onde participaram profissionais experientes em medicina intensiva. Esses profissionais foram subdivididos em 3 subgrupos, que discutiram: comunicação em unidade de terapia intensiva, decisões diante de um doente terminal e cuidados/ações paliativas na unidade de terapia intensiva. As informações e referências bibliográficas foram copiladas e trabalhadas através de um site de acesso restrito. Os trabalhos ocorreram em 12 horas quando foram realizadas discussões sistematizadas seguindo o método Delphi modificado. Foram elaboradas definições sobre a terminalidade. A adequada comunicação foi considerada de primordial importância para a condução do tratamento de um paciente terminal. Foram descritas barreiras de comunicação que devem ser evitadas sendo definidas técnicas para a boa comunicação. Foram também definidos os critérios para cuidados e ações paliativas nas unidades de terapia intensiva, sendo considerada fundamental a aceitação da morte, como um evento natural, e o respeito à autonomia e não maleficência do paciente. Considerou-se aconselhável a suspensão de medicamentos fúteis, que prolonguem o morrer e a adequação dos tratamentos não fúteis privilegiando o controle da dor e dos sintomas para o alívio do sofrimento dos pacientes com doença terminal. Para a prestação de cuidados paliativos a pacientes críticos e seus familiares, devem ser seguidos princípios e metas que visem o respeito às necessidades e anseios individuais. Os profissionais da unidade de terapia intensiva envolvidos com o tratamento desses pacientes são submetidos a grande estresse e tensão...

The objective of this review was to evaluate current knowledge regarding terminal illness and palliative care in the intensive care unit, to identify the major challenges involved and propose a research agenda on these issues The Brazilian Critical Care Association organized a specific forum on terminally ill patients, to which were invited experienced and skilled professionals on critical care. These professionals were divided in three groups: communication in the intensive care unit, the decision making process when faced with a terminally ill patient and palliative actions and care in the intensive care unit. Data and bibliographic references were stored in a restricted website. During a twelve hour meeting and following a modified Delphi methodology, the groups prepared the final document. Consensual definition regarding terminality was reached. Good communication was considered the cornerstone to define the best treatment for a terminally ill patient. Accordingly some communication barriers were described that should be avoided as well as some approaches that should be pursued. Criteria for palliative care and palliative action in the intensive care unit were defined. Acceptance of death as a natural event as well as respect for the patient's autonomy and the nonmaleficence principles were stressed. A recommendation was made to withdraw the futile treatment that prolongs the dying process and to elected analgesia and measures that alleviate suffering in terminally ill patients. To deliver palliative care to terminally ill patients and their relatives some principles and guides should be followed, respecting individual necessities and beliefs. The intensive care unit staff involved with the treatment of terminally ill patients is subject to stress and tension. Availability of a continuous education program on palliative care is desirable.

Epidemiologia e desfecho de pacientes cirúrgicos não cardíacos em unidades de terapia intensiva no Brasil / Epidemiology and outcomes of non-cardiac surgical patients in Brazilian intensive care units

OBJETIVO: Devido aos avanços da medicina e ao envelhecimento da população, a proporção de pacientes em risco de morte após cirurgias está aumentando. Nosso objetivo foi avaliar o desfecho e a epidemiologia de cirurgias não cardíacas em pacientes admitidos em unidade de terapia intensiva. MÉTODOS: Estudo prospectivo, observacional, de coorte, realizado em 21 unidades de terapia intensiva. Um total de 885 pacientes adultos, cirúrgicos, consecutivamente admitidos em unidades de terapia intensiva no período de abril a junho de 2006 foi avaliado e destes, 587 foram incluídos. Os critérios de exclusão foram; trauma, cirurgias cardíacas, neurológicas, ginecológicas, obstétricas e paliativas. Os principais desfechos foram complicações pós-cirúrgicas e mortalidade na unidade de terapia intensiva e 90 dias após a cirurgia. RESULTADOS: Cirurgias de grande porte e de urgência foram realizadas em 66,4 por cento e 31,7 por cento, dos pacientes, respectivamente. A taxa de mortalidade na unidade de terapia intensiva foi de 15 por cento, e 38 por cento dos pacientes tiveram complicações no pós-operatório. A complicação mais comum foi infecção ou sepse (24,7 por cento). Isquemia miocárdica foi diagnosticada em apenas 1,9 por cento. Um total de 94 por cento dos pacientes que morreram após a cirurgia tinha co-morbidades associadas (3,4 ± 2,2). A principal causa de óbito foi disfunção de múltiplos órgãos (53 por cento). CONCLUSÃO: Sepse é a causa predominante de morbidade em pacientes submetidos a cirurgias não cardíacas. A grande maioria dos óbitos no pós-operatório ocorreu por disfunção de múltiplos órgãos.

OBJECTIVES: Due to the dramatic medical breakthroughs and an increasingly ageing population, the proportion of patients who are at risk of dying following surgery is increasing over time. The aim of this study was to evaluate the outcomes and the epidemiology of non-cardiac surgical patients admitted to the intensive care unit. METHODS: A multicenter, prospective, observational, cohort study was carried out in 21 intensive care units. A total of 885 adult surgical patients admitted to a participating intensive care unit from April to June 2006 were evaluated and 587 patients were enrolled. Exclusion criteria were trauma, cardiac, neurological, gynecologic, obstetric and palliative surgeries. The main outcome measures were postoperative complications and intensive care unit and 90-day mortality rates. RESULTS: Major and urgent surgeries were performed in 66.4 percent and 31.7 percent of the patients, respectively. The intensive care unit mortality rate was 15 percent, and 38 percent of the patients had postoperative complications. The most common complication was infection or sepsis (24.7 percent). Myocardial ischemia was diagnosed in only 1.9 percent of the patients. A total of 94 percent of the patients who died after surgery had co-morbidities at the time of surgery (3.4 ± 2.2). Multiple organ failure was the main cause of death (53 percent). CONCLUSION: Sepsis is the predominant cause of morbidity in patients undergoing non-cardiac surgery. In this patient population, multiple organ failure prevailed as the most frequent cause of death in the hospital.

Epidemiology and outcomes of non-cardiac surgical patients in Brazilian intensive care units. / Epidemiologia e desfecho de pacientes cirúrgicos não cardíacos em unidades de terapia intensiva no Brasil.

OBJECTIVES: Due to the dramatic medical breakthroughs and an increasingly ageing population, the proportion of patients who are at risk of dying following surgery is increasing over time. The aim of this study was to evaluate the outcomes and the epidemiology of non-cardiac surgical patients admitted to the intensive care unit. METHODS: A multicenter, prospective, observational, cohort study was carried out in 21 intensive care units. A total of 885 adult surgical patients admitted to a participating intensive care unit from April to June 2006 were evaluated and 587 patients were enrolled. Exclusion criteria were trauma, cardiac, neurological, gynecologic, obstetric and palliative surgeries. The main outcome measures were postoperative complications and intensive care unit and 90-day mortality rates. RESULTS: Major and urgent surgeries were performed in 66.4% and 31.7% of the patients, respectively. The intensive care unit mortality rate was 15%, and 38% of the patients had postoperative complications. The most common complication was infection or sepsis (24.7%). Myocardial ischemia was diagnosed in only 1.9% of the patients. A total of 94 % of the patients who died after surgery had co-morbidities at the time of surgery (3.4 ± 2.2). Multiple organ failure was the main cause of death (53%). CONCLUSION: Sepsis is the predominant cause of morbidity in patients undergoing non-cardiac surgery. In this patient population, multiple organ failure prevailed as the most frequent cause of death in the hospital.

End of life and palliative care in intensive care unit. / Terminalidade e cuidados paliativos na unidade de terapia intensiva.

The objective of this review was to evaluate current knowledge regarding terminal illness and palliative care in the intensive care unit, to identify the major challenges involved and propose a research agenda on these issues The Brazilian Critical Care Association organized a specific forum on terminally ill patients, to which were invited experienced and skilled professionals on critical care. These professionals were divided in three groups: communication in the intensive care unit, the decision making process when faced with a terminally ill patient and palliative actions and care in the intensive care unit. Data and bibliographic references were stored in a restricted website. During a twelve hour meeting and following a modified Delphi methodology, the groups prepared the final document. Consensual definition regarding terminality was reached. Good communication was considered the cornerstone to define the best treatment for a terminally ill patient. Accordingly some communication barriers were described that should be avoided as well as some approaches that should be pursued. Criteria for palliative care and palliative action in the intensive care unit were defined. Acceptance of death as a natural event as well as respect for the patient's autonomy and the nonmaleficence principles were stressed. A recommendation was made to withdraw the futile treatment that prolongs the dying process and to elected analgesia and measures that alleviate suffering in terminally ill patients. To deliver palliative care to terminally ill patients and their relatives some principles and guides should be followed, respecting individual necessities and beliefs. The intensive care unit staff involved with the treatment of terminally ill patients is subject to stress and tension. Availability of a continuous education program on palliative care is desirable.

Ventilação mecânica no Brasil: aspectos epidemiológicos / Mechanical ventilation in Brazil: epidemiological aspects

JUSTIFICATIVA E OBJETIVOS: Existem poucos estudos epidemiológicos em ventilação mecânica. O objetivo deste estudo foi demonstrar como a ventilação mecânica vem sendo realizada nas UTI brasileiras. MÉTODO: O estudo foi realizado com prevalência de um dia em 40 UTI, com 390 pacientes internados, sendo 217 em ventilação mecânica. Os resultados medidos foram a caracterização dos pacientes ventilados, sua distribuição pelo Brasil, as causas da ventilação mecânica, os principais modos ventilatórios usados, os parâmetros ventilatórios mais importantes e a fase de desmame da ventilação mecânica. RESULTADOS: As medianas da idade dos pacientes ventilados, do escore APACHE II, e do tempo de ventilação mecânica foram, respectivamente, de 66 anos, 20 pontos e 11 dias. A ventilação mecânica foi determinada pela insuficiência respiratória aguda (IRA) em 71 por cento dos pacientes, o coma em 21,2 por cento, a doença pulmonar obstrutiva crônica em 5,5 por cento e a doença neuromuscular em 2,3 por cento. A ventilação controlada a volume (VCV) (30 por cento), a ventilação com pressão de suporte (PSV) (29,5 por cento) e a ventilação controlada à pressão (PCV) (18 por cento) foram as mais utilizadas, sendo que no desmame predominou a PSV (63,5 por cento). A mediana do volume corrente foi maior nos pacientes em VCV (8 mL/kg). As medianas de pressão inspiratória máxima (30 cmH2O) e de pressão positiva no fim da expiração (PEEP) (8 cmH2O) foram maiores nos pacientes em PCV. CONCLUSÕES: O predomínio de pacientes ventilados nas UTI foi indicado pela sua maior gravidade clínica e pelo maior tempo de internação. A IRA foi a principal indicação de ventilação mecânica. VCV e PSV ventilaram mais pacientes, sendo a PSV na fase de desmame ventilatório.

BACKGROUND AND OBJECTIVES: There are few epidemiological studies in mechanical ventilation, and the aim of the study is to show how this procedure is being used in Brazil. METHODS: A 1-day point prevalence study was performed in 40 ICUs, with 390 patients; 217 of these patients were in mechanical ventilation. The results evaluated were the characteristics of ventilated patients, their distribution in Brazil, the mechanical ventilation's causes, the main ventilatory modes, the more important ventilators settings, and the weaning stage of mechanical ventilation. RESULTS: The median age of the ventilated patients was 66 years old. The median APACHE II was 20, while the median time of mechanical ventilation was 11 days. Acute respiratory failure occurred in 71 percent of the patients, coma in 21.2 percent, acute exacerbation of chronic respiratory failure in 5.5 percent, and the neuromuscular disease in 2.3 percent. The volume-controlled ventilation (VCV) (30 percent), the pressure support ventilation (PSV) (29.5 percent), and the pressure-controlled ventilation (PCV) (18 percent) were the ventilatory modes most used; the PSV had been the main mode in weaning (63.5 percent). The median of tidal volume (8 mL/kg) was higher in VCV. The median of maximal inspiratory pression (30 cmH2O) and the median of positive end-expiration pressure (PEEP) (8 cmH2O) were higher in PCV. CONCLUSIONS: The predominance of ventilated patients in ICUs was marked by clinical severity of them, and a longer hospital stay time; acute respiratory failure was the principal mechanical ventilation cause; VCV and PSV ventilated more patients, with PSV being more used in weaning patients.

Profilaxia para úlcera de estresse nas unidades de terapia intensiva: estudo observacional multicêntrico / Stress ulcer prophylaxis in intensive care units: an observational multicenter study

JUSTIFICATIVA E OBJETIVOS: O sangramento digestivo por úlcera de estresse (SDUE) é uma complicação grave dos pacientes criticamente doentes e com necessidade de profilaxia baseada em critérios literários definidos. O objetivo deste estudo foi revisar o uso de profilaxia para SDUE em UTI do Estado do Rio Grande do Sul, comparando os resultados com as evidências atuais da literatura. MÉTODO: Estudo transversal realizado em um único dia, com coleta de dados de todos os pacientes internados em 21 unidades de terapia intensiva (UTI). Para análise dos dados, os pacientes foram distribuídos em três subgrupos (alto, médio e baixo risco de SDUE). RESULTADOS: Foram analisados 235 pacientes internados, com média de idade de 57,7 ± 19,5 anos e tempo médio de internação em UTI de 13 ± 19,7 dias. Os motivos de internação mais freqüentes foram sepse (26 por cento) e pós-operatório de grandes cirurgias (16,2 por cento). Da totalidade, 73 por cento eram de alto risco para SDUE, 21,5 por cento de risco intermediário e 5,5 por cento de baixo risco. Dos 187 pacientes de alto risco, 139 estavam usando bloqueadores para SDUE (60 por cento com bloqueadores histaminérgicos (BH2) e 39 por cento com inibidor de bomba de prótons (IBP) para profilaxia (60 por cento). Não recebiam profilaxia, apesar de indicada, 25,7 por cento destes pacientes de alto risco. Dos 55 pacientes de risco intermediário para SDUE, 70,9 por cento recebiam profilaxia (22 com BH2 e 17 com IBP) e dos 14 pacientes de baixo risco, 71 por cento recebiam profilaxia (6 com BH2 e 4 com IBP). CONCLUSÕES: Este artigo traduziu a ausência de estratificação de risco para SDUE nas UTI do Estado, além da indicação de fármacos gastro-protetores sem critérios precisos para o seu emprego.

BACKGROUND AND OBJECTIVES: Gastrointestinal bleeding due to stress ulcer (GB) complicates critical disease, and must be received prophylaxis based on defined criteria. To evaluate the GB prophylaxis in Intensive Care Units (ICU), and to compare with the guidelines. METHODS: We carried out a cross-sectional multicenter study in 21 medical-surgical ICU in Brazil to investigate this issue. For data analysis, these were distributed in 3 sub-groups (high, moderate and low risk for GB). RESULTS: 235 patients were evaluated, with mean age of 57.7 ± 19.5 years and days on ICU 13 ± 19.7. The more common admission ICU diagnoses were sepsis (26 percent) and postoperative (16.2 percent) patients. Seventy-three (73 percent) of the patients were GB high risk, 21.5 percent moderate and 5.5 percent low risk. Of the 187 high risk patients, 139 were receiving GB prophylaxis (60 percent with histamine blockers (HB2) and 39 percent with proton pump inhibitors (PPI). Of these patients, 25.7 percent did not receive GU prophylaxis, although indicated it. Of the 55 moderate risk patients, 70.9 percent wer e receiving GU prophylaxis (22 with HB2 and 17 with PPI). Of the 14 low risk patients, 71 percent were using GU prophylaxis (6 with HB2 and 4 with PPI). CONCLUSIONS: Almost 80 percent of the patients made use of GB prophylactic drugs, with no agreement GU risk stratification. This study demonstrated the no adequate GU prophylaxis in the Brazilian ICU.

[Mechanical ventilation in Brazil: epidemiological aspects]. / Ventilação mecânica no Brasil: aspectos epidemiológicos.

BACKGROUND AND OBJECTIVES: There are few epidemiological studies in mechanical ventilation, and the aim of the study is to show how this procedure is being used in Brazil. METHODS: A 1-day point prevalence study was performed in 40 ICUs, with 390 patients; 217 of these patients were in mechanical ventilation. The results evaluated were the characteristics of ventilated patients, their distribution in Brazil, the mechanical ventilation's causes, the main ventilatory modes, the more important ventilators settings, and the weaning stage of mechanical ventilation. RESULTS: The median age of the ventilated patients was 66 years old. The median APACHE II was 20, while the median time of mechanical ventilation was 11 days. Acute respiratory failure occurred in 71% of the patients, coma in 21.2%, acute exacerbation of chronic respiratory failure in 5.5%, and the neuromuscular disease in 2.3%. The volume-controlled ventilation (VCV) (30%), the pressure support ventilation (PSV) (29.5%), and the pressure-controlled ventilation (PCV) (18%) were the ventilatory modes most used; the PSV had been the main mode in weaning (63.5%). The median of tidal volume (8 mL/kg) was higher in VCV. The median of maximal inspiratory pression (30 cmH2O) and the median of positive end-expiration pressure (PEEP) (8 cmH2O) were higher in PCV. CONCLUSIONS: The predominance of ventilated patients in ICUs was marked by clinical severity of them, and a longer hospital stay time; acute respiratory failure was the principal mechanical ventilation cause; VCV and PSV ventilated more patients, with PSV being more used in weaning patients.

Partial liquid ventilation with perfluorodecalin following unilateral canine lung allotransplantation in non-heart-beating donors.

BACKGROUND: The purpose of this study was to evaluate canine lungs obtained from non-heart-beating donors after unilateral lung transplantation subjected to partial liquid ventilation with perfluorodecalin. METHODS: Twelve donor dogs were killed and kept under mechanical ventilation for 3 hours. Heart-lung blocks were harvested after retrograde pulmonary hypothermic flush with Perfadex. Left lung grafts were randomly transplanted into 12 weight-matched recipient animals. Animals were divided into 2 groups: control (standard mechanical ventilation, n = 6) and PLV (partial liquid ventilation, n = 6). Forty-five minutes after transplantation, the animals in the PLV group received perfluorodecalin (15 ml/kg) via orotracheal tube. All animals received volume-controlled ventilation (FIO2) 1.0, PEEP 5 cm H(2)O) over 6 consecutive hours. Thereafter, blood-gas analysis, ventilatory mechanics and hemodynamics were registered at 30-minute intervals. After 6 hours of reperfusion the animals were killed and the transplanted lungs were extracted to obtain the wet/dry weight ratio. RESULTS: There were significant differences in pulmonary arterial pressure, which were higher in control group animals (p < 0.009). The control animals also showed higher arterial PaO(2) than those in the PLV group (p < 0.00001), but lower PaCO(2) (p < 0.008). The peak and plateau pressures were higher in the PLV group (p < 0.00001). Neither static compliance nor wet/dry weight ratios were different in between groups. CONCLUSIONS: PLV with perfluorodecalin yields functional results compatible with life in this model. Nonetheless, pulmonary gas exchange and mechanics were superior after reperfusion in animals given conventional mechanical ventilation up to 6 hours after left lung allotransplantation.