Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial. / Plano de análise estatística de um ensaio clínico randomizado em cluster em unidades de terapia intensiva geral adulto no Brasil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE).

OBJECTIVE: The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care. METHODS: The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of daily multidisciplinary rounds conducted by an intensivist through telemedicine in Brazilian intensive care units. The protocol was approved by the local Research Ethics Committee of the coordinating study center and by the local Research Ethics Committee from each of the 30 intensive care units, following Brazilian legislation. The trial is registered with ClinicalTrials. gov (NCT03920501). The primary outcome is intensive care unit length of stay, which will be analyzed accounting for the baseline period and cluster structure of the data and adjusted by prespecified covariates. Secondary exploratory outcomes included intensive care unit performance classification, in-hospital mortality, incidence of nosocomial infections, ventilator-free days at 28 days, rate of patients receiving oral or enteral feeding, rate of patients under light sedation or alert and calm, and rate of patients under normoxemia. CONCLUSION: According to the trial's best practice, we report our statistical analysis prior to locking the database and beginning analyses. We anticipate that this reporting practice will prevent analysis bias and improve the interpretation of the reported results.ClinicalTrials.gov registration: NCT03920501.

OBJETIVO: O ensaio TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) visa avaliar se uma intervenção complexa por telemedicina em unidades de terapia intensiva, que se concentra em rondas multidisciplinares diárias realizadas por intensivistas a distância, reduzirá o tempo de permanência na unidade de terapia intensiva em comparação com os cuidados habituais. MÉTODOS: O TELESCOPE é um ensaio nacional, multicêntrico, controlado, aberto, randomizado em cluster. O estudo testa a eficácia de rondas multidisciplinares diárias realizadas por um intensivista por meio de telemedicina em unidades de terapia intensiva brasileiras. O protocolo foi aprovado pelo Comitê de Ética em Pesquisa local do centro coordenador do estudo e pelo Comitê de Ética em Pesquisa local de cada uma das 30 unidades de terapia intensiva, de acordo com a legislação brasileira. O ensaio está registado no ClinicalTrials.gov (NCT03920501). O desfecho primário é o tempo de internação na unidade de terapia intensiva, que será analisado considerando o período basal e a estrutura dos dados em cluster, sendo ajustado por covariáveis predefinidas. Os desfechos exploratórios secundários incluem a classificação de desempenho da unidade de terapia intensiva, a mortalidade hospitalar, a incidência de infecções nosocomiais, o número de dias sem ventilação mecânica aos 28 dias, a taxa de pacientes que recebem alimentação oral ou enteral, a taxa de pacientes sob sedação leve ou em alerta e calmos e a taxa de pacientes sob normoxemia. CONCLUSÃO: De acordo com as melhores práticas do ensaio, divulgamos nossa análise estatística antes de bloquear a base de dados e iniciar as análises. Esperamos que essa prática de notificação evite o viés das análises e aprimore a interpretação dos resultados apresentados.Registro no ClinicalTrials.gov: NCT03920501.

Plano de análise estatística de um ensaio clínico randomizado em cluster em unidades de terapia intensiva geral adulto no Brasil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) / Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial

RESUMO Objetivo: O ensaio TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) visa avaliar se uma intervenção complexa por telemedicina em unidades de terapia intensiva, que se concentra em rondas multidisciplinares diárias realizadas por intensivistas a distância, reduzirá o tempo de permanência na unidade de terapia intensiva em comparação com os cuidados habituais. Métodos: O TELESCOPE é um ensaio nacional, multicêntrico, controlado, aberto, randomizado em cluster. O estudo testa a eficácia de rondas multidisciplinares diárias realizadas por um intensivista por meio de telemedicina em unidades de terapia intensiva brasileiras. O protocolo foi aprovado pelo Comitê de Ética em Pesquisa local do centro coordenador do estudo e pelo Comitê de Ética em Pesquisa local de cada uma das 30 unidades de terapia intensiva, de acordo com a legislação brasileira. O ensaio está registado no ClinicalTrials.gov (NCT03920501). O desfecho primário é o tempo de internação na unidade de terapia intensiva, que será analisado considerando o período basal e a estrutura dos dados em cluster, sendo ajustado por covariáveis predefinidas. Os desfechos exploratórios secundários incluem a classificação de desempenho da unidade de terapia intensiva, a mortalidade hospitalar, a incidência de infecções nosocomiais, o número de dias sem ventilação mecânica aos 28 dias, a taxa de pacientes que recebem alimentação oral ou enteral, a taxa de pacientes sob sedação leve ou em alerta e calmos e a taxa de pacientes sob normoxemia. Conclusão: De acordo com as melhores práticas do ensaio, divulgamos nossa análise estatística antes de bloquear a base de dados e iniciar as análises. Esperamos que essa prática de notificação evite o viés das análises e aprimore a interpretação dos resultados apresentados. Registro no ClinicalTrials.gov:NCT03920501

ABSTRACT Objective: The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care. Methods: The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of daily multidisciplinary rounds conducted by an intensivist through telemedicine in Brazilian intensive care units. The protocol was approved by the local Research Ethics Committee of the coordinating study center and by the local Research Ethics Committee from each of the 30 intensive care units, following Brazilian legislation. The trial is registered with ClinicalTrials. gov (NCT03920501). The primary outcome is intensive care unit length of stay, which will be analyzed accounting for the baseline period and cluster structure of the data and adjusted by prespecified covariates. Secondary exploratory outcomes included intensive care unit performance classification, in-hospital mortality, incidence of nosocomial infections, ventilator-free days at 28 days, rate of patients receiving oral or enteral feeding, rate of patients under light sedation or alert and calm, and rate of patients under normoxemia. Conclusion: According to the trial's best practice, we report our statistical analysis prior to locking the database and beginning analyses. We anticipate that this reporting practice will prevent analysis bias and improve the interpretation of the reported results. ClinicalTrials.gov registration:NCT03920501

Resuscitation fluid practices in Brazilian intensive care units: a secondary analysis of Fluid-TRIPS. / Práticas de ressuscitação volêmica em unidades de terapia intensiva brasileiras: uma análise secundária do estudo Fluid-TRIPS.

OBJECTIVE: To describe fluid resuscitation practices in Brazilian intensive care units and to compare them with those of other countries participating in the Fluid-TRIPS. METHODS: This was a prospective, international, cross-sectional, observational study in a convenience sample of intensive care units in 27 countries (including Brazil) using the Fluid-TRIPS database compiled in 2014. We described the patterns of fluid resuscitation use in Brazil compared with those in other countries and identified the factors associated with fluid choice. RESULTS: On the study day, 3,214 patients in Brazil and 3,493 patients in other countries were included, of whom 16.1% and 26.8% (p < 0.001) received fluids, respectively. The main indication for fluid resuscitation was impaired perfusion and/or low cardiac output (Brazil: 71.7% versus other countries: 56.4%, p < 0.001). In Brazil, the percentage of patients receiving crystalloid solutions was higher (97.7% versus 76.8%, p < 0.001), and 0.9% sodium chloride was the most commonly used crystalloid (62.5% versus 27.1%, p < 0.001). The multivariable analysis suggested that the albumin levels were associated with the use of both crystalloids and colloids, whereas the type of fluid prescriber was associated with crystalloid use only. CONCLUSION: Our results suggest that crystalloids are more frequently used than colloids for fluid resuscitation in Brazil, and this discrepancy in frequencies is higher than that in other countries. Sodium chloride (0.9%) was the crystalloid most commonly prescribed. Serum albumin levels and the type of fluid prescriber were the factors associated with the choice of crystalloids or colloids for fluid resuscitation.

OBJETIVO: Descrever as práticas de ressuscitação volêmica em unidades de terapia intensiva brasileiras e compará-las com as de outros países participantes do estudo Fluid-TRIPS. MÉTODOS: Este foi um estudo observacional transversal, prospectivo e internacional, de uma amostra de conveniência de unidades de terapia intensiva de 27 países (inclusive o Brasil), com utilização da base de dados Fluid-TRIPS compilada em 2014. Descrevemos os padrões de ressuscitação volêmica utilizados no Brasil em comparação com os de outros países e identificamos os fatores associados com a escolha dos fluidos. RESULTADOS: No dia do estudo, foram incluídos 3.214 pacientes do Brasil e 3.493 pacientes de outros países, dos quais, respectivamente, 16,1% e 26,8% (p < 0,001) receberam fluidos. A principal indicação para ressuscitação volêmica foi comprometimento da perfusão e/ou baixo débito cardíaco (Brasil 71,7% versus outros países 56,4%; p < 0,001). No Brasil, a percentagem de pacientes que receberam soluções cristaloides foi mais elevada (97,7% versus 76,8%; p < 0,001), e solução de cloreto de sódio a 0,9% foi o cristaloide mais comumente utilizado (62,5% versus 27,1%; p < 0,001). A análise multivariada sugeriu que os níveis de albumina se associaram com o uso tanto de cristaloides quanto de coloides, enquanto o tipo de prescritor dos fluidos se associou apenas com o uso de cristaloides. CONCLUSÃO: Nossos resultados sugerem que cristaloides são usados mais frequentemente do que coloides para ressuscitação no Brasil, e essa discrepância, em termos de frequências, é mais elevada do que em outros países. A solução de cloreto de sódio 0,9% foi o cristaloide mais frequentemente prescrito. Os níveis de albumina sérica e o tipo de prescritor de fluidos foram os fatores associados com a escolha de cristaloides ou coloides para a prescrição de fluidos.

TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE): protocol for a cluster-randomised clinical trial on adult general ICUs in Brazil.

INTRODUCTION: Daily multidisciplinary rounds (DMRs) consist of systematic patient-centred discussions aiming to establish joint therapeutic goals for the next 24 hours of intensive care unit (ICU) care. The aim of the present study protocol is to evaluate whether an intervention consisting of guided DMRs, supported by a remote specialist and audit/feedback on care performance will reduce ICU length of stay compared with a control group. METHODS AND ANALYSIS: A multicentre, controlled, cluster-randomised superiority trial including 30 ICUs in Brazil (15 intervention and 15 control), from August 2019 to June 2021. In a parallel assignment, ICUs are randomised to a complex-intervention composed by daily rounds carried out through Tele-ICU by a remote ICU physician; development of local quality indicators dashboards coupled with monthly meetings with local leadership; and dissemination of evidence-based clinical protocols versus usual care. Primary outcome is ICU length of stay. Secondary outcomes include classification of the unit according to the profiles defined by the standardised resource use and the standardised mortality rate, hospital mortality, incidence of healthcare-associated infections, ventilator-free days at 28 days, patient-days receiving oral or enteral feeding, patient-days under light sedation or alert and calm, rate of patients under normoxaemia. All adult patients admitted after the beginning of the study in each participant ICU will be enrolled. Inclusion criteria (clusters): public Brazilian ICUs with a minimum of 8 ICU beds interested/committed to participating in the study. Exclusion criteria (clusters): units with fully established DMRs by an intensivist, specialised or step-down units. ETHICS AND DISSEMINATION: The study protocol was approved by the institutional review board (IRB) of the coordinator centre, and by IRBs of each enrolled hospital/ICU. Statistical analysis protocol is being prepared for submission before the end of patient's enrolment. Results will be disseminated through conferences, peer-reviewed journals and to each participating unit. TRIAL REGISTRATION NUMBER: NCT03920501; Pre-results.

Nighttime intensive care unit discharge and outcomes: A propensity matched retrospective cohort study.

BACKGROUND: Nighttime ICU discharge, i.e., discharge from the ICU during the night hours, has been associated with increased readmission rates, hospital length of stay (LOS) and in-hospital mortality. We sought to determine the frequency of nighttime ICU discharge and identify whether nighttime ICU discharge is associated with worse outcomes in a private adult ICU located in Brazil. METHODS: Post hoc analysis of a cohort study addressing the effect of ICU readmissions on outcomes. This retrospective, single center, propensity matched cohort study was conducted in a medical-surgical ICU located in a private tertiary care hospital in São Paulo, Brazil. Based on time of transfer, patients were categorized into nighttime (7:00 pm to 6:59 am) and daytime (7:00 am to 6:59 pm) ICU discharge and were propensity-score matched at a 1:2 ratio. The primary outcome of interest was in-hospital mortality. RESULTS: Among 4,313 eligible patients admitted to the ICU between June 2013 and May 2015, 1,934 patients were matched at 1:2 ratio [649 (33.6%) nighttime and 1,285 (66.4%) daytime discharged patients]. The median (IQR) cohort age was 66 (51-79) years and SAPS III score was 43 (33-55). In-hospital mortality was 6.5% (42/649) in nighttime compared to 5.6% (72/1,285) in daytime discharged patients (OR, 1.17; 95% CI, 0.79 to 1.73; p = 0.444). While frequency of ICU readmission (OR, 0.95; 95% CI, 0.78 to 1.29; p = 0.741) and length of hospital stay did not differ between the groups, length of ICU stay was lower in nighttime compared to daytime ICU discharged patients [1 (1-3) days vs. 2 (1-3) days, respectively, p = 0.047]. CONCLUSION: In this propensity-matched retrospective cohort study, time of ICU discharge did not affect in-hospital mortality.

Acid base variables predict survival early in the course of treatment with continuous venovenous hemodiafiltration.

Metabolic acid-base disorders, especially metabolic acidosis, are common in critically ill patients who require renal replacement therapy. Continuous veno-venous hemodiafiltration (CVVHDF) achieves profound changes in acid-base status, but metabolic acidosis can remain unchanged or even deteriorate in some patients. The objective of this study is to understand the changes of acid-base variables in critically ill patients with septic associated acute kidney injury (SA-AKI) during CVVHDF and to determine how they relate to clinical outcome.Observational study of 200 subjects with SA-AKI treated with CVVHDF for at least 72 hours. Arterial blood gases and electrolytes and other relevant acid-base variables were analyzed using quantitative acid-base chemistry.Survivors and nonsurvivors had similar demographic characteristics and acid-base variables on day one of CVVHDF. However, during the next 48 hours, the resolution of acidosis was significantly different between the 2 groups, with an area under the ROC curve for standard base excess (SBE) and mortality of 0.62 (0.54-0.70), this was better than APACHE II score prediction power. Quantitative physicochemical analysis revealed that the majority of the change in SBE was due to changes in Cl and Na concentrations.Survivors of SA-AKI treated with CVVHDF recover hyperchloremic metabolic acidosis more rapidly than nonsurvivors. Further study is needed to determine if survival can be improved by measures to correct acidosis more rapidly.

Peripherally inserted central catheters are associated with lower risk of bloodstream infection compared with central venous catheters in paediatric intensive care patients: a propensity-adjusted analysis.

PURPOSE: Central line-associated bloodstream infection (CLABSI) is an important cause of complications in paediatric intensive care units (PICUs). Peripherally inserted central catheters (PICCs) could be an alternative to central venous catheters (CVCs) and the effect of PICCs compared with CVCs on CLABSI prevention is unknown in PICUs. Therefore, we aimed to evaluate whether PICCs were associated with a protective effect for CLABSI when compared to CVCs in critically ill children. METHODS: We have carried out a retrospective multicentre study in four PICUs in São Paulo, Brazil. We included patients aged 0-14 years, who needed a CVC or PICC during a PICU stay from January 2013 to December 2015. Our primary endpoint was CLABSI up to 30 days after catheter placement. We defined CLABSI based on the Center for Disease Control and Prevention's National Healthcare Safety Networks (NHSN) 2015 surveillance definitions. To account for potential confounders, we used propensity scores with inverse probability weighting. RESULTS: A total of 1660 devices (922 PICCs and 738 CVCs) in 1255 children were included. The overall CLABSI incidence was 2.28 (95% CI 1.70-3.07)/1000 catheter-days. After covariate adjustment using propensity scores, CVCs were associated with higher risk of CLABSI (adjHR 2.20, 95% CI 1.05-4.61; p = 0.037) compared with PICCs. In a sensitivity analysis, CVCs remained associated with higher risk of CLABSI (adjHR 2.18, 95% CI 1.02-4.64; p = 0.044) after adding place of insertion and use of parenteral nutrition to the model as a time-dependent variable. CONCLUSIONS: PICC should be an alternative to CVC in the paediatric intensive care setting for CLABSI prevention.

The Challenge of Predicting Pressure Ulcers in Critically Ill Patients. A Multicenter Cohort Study.

RATIONALE: Pressure ulcers are preventable events. Critically ill patients are particularly vulnerable. The Braden scale has been used to identify hospitalized patients at high risk for the development of pressure ulcers; however, this predictive tool has not been adequately validated for critically ill patients. OBJECTIVES: We aimed to validate and improve the Braden scale for critically ill patients by adding clinical variables to the original scale. METHODS: We conducted a cohort study in 12 intensive care units (ICUs) within a network of hospitals in Brazil during 2013. We excluded patients who stayed less than 48 hours, patients with one or more pressure ulcers at admission, and those who developed a pressure ulcer within the first 48 hours. We evaluated the Braden scale and clinical variables through a competing risk analysis. Discrimination and calibration were evaluated using the Concordance index (C-index) and a calibration plot, respectively. We used bootstrapping to assess internal validation. MEASUREMENTS AND MAIN RESULTS: Our primary outcome was incident pressure ulcer within 30 days of ICU admission. We analyzed 9,605 patients and observed 157 pressure ulcers (rate of 3.33 pressure ulcers/1,000 patient-days). The majority of pressure ulcers were detected at stage I or II (28.7 and 66.2%, respectively). The Braden scale had good discrimination (C-index, 0.753; 95% confidence interval, 0.712-0.795), although its performance decreased for the most severely ill patients. We derived a modified predictive tool by adding eight clinical variables to the Braden scale: age, sex, diabetes mellitus, hematological malignancy, peripheral artery disease, hypotension at ICU admission, and need for mechanical ventilation or renal replacement therapy in the first 24 hours after ICU admission. The derived score had better discrimination and calibration than the original Braden scale. The best score cutoff was at least 6 points, with a sensitivity of 87% and a specificity of 71%. CONCLUSIONS: The original Braden scale measured at ICU admission is a valuable tool for pressure ulcer prediction, although it is not accurate for severely ill patients. To overcome the limitations of the original scale, we derived a modified score with better performance, which may identify high-risk ICU patients and support target interventions. External validation of the proposed clinical prediction score is needed.

Evaluation of cost-effectiveness from the funding body's point of view of ultrasound-guided central venous catheter insertion compared with the conventional technique.

OBJECTIVE: To evaluate the cost-effectiveness, from the funding body's point of view, of real-time ultrasound-guided central venous catheter insertion compared to the traditional method, which is based on the external anatomical landmark technique. METHODS: A theoretical simulation based on international literature data was applied to the Brazilian context, i.e., the Unified Health System (Sistema Único de Saúde - SUS). A decision tree was constructed that showed the two central venous catheter insertion techniques: real-time ultrasonography versus external anatomical landmarks. The probabilities of failure and complications were extracted from a search on the PubMed and Embase databases, and values associated with the procedure and with complications were taken from market research and the Department of Information Technology of the Unified Health System (DATASUS). Each central venous catheter insertion alternative had a cost that could be calculated by following each of the possible paths on the decision tree. The incremental cost-effectiveness ratio was calculated by dividing the mean incremental cost of real-time ultrasound compared to the external anatomical landmark technique by the mean incremental benefit, in terms of avoided complications. RESULTS: When considering the incorporation of real-time ultrasound and the concomitant lower cost due to the reduced number of complications, the decision tree revealed a final mean cost for the external anatomical landmark technique of 262.27 Brazilian reals (R$) and for real-time ultrasound of R$187.94. The final incremental cost of the real-time ultrasound-guided technique was -R$74.33 per central venous catheter. The incremental cost-effectiveness ratio was -R$2,494.34 due to the pneumothorax avoided. CONCLUSION: Real-time ultrasound-guided central venous catheter insertion was associated with decreased failure and complication rates and hypothetically reduced costs from the view of the funding body, which in this case was the SUS.

Avaliação de custo-efetividade da passagem de cateter venoso central guiada por ultrassonografia comparada com a técnica convencional sob perspectiva da fonte pagadora / Evaluation of cost-effectiveness from the funding body's point of view of ultrasound-guided central venous catheter insertion compared with the conventional technique

RESUMO Objetivo: Avaliar o custo-efetividade da inserção de cateter venoso central guiada por ultrassonografia em tempo real, em comparação com a técnica tradicional, que é baseada na técnica de reparos anatômicos externos, sob a perspectiva da fonte pagadora. Métodos: Uma simulação teórica, baseada em dados de literatura internacional foi aplicada ao contexto brasileiro, ou seja, ao Sistema Único de Saúde (SUS). Foi estruturada uma árvore de decisão, que apresentava as duas técnicas para inserção de cateter venoso central: ultrassonografia em tempo real versus reparos anatômicos externos. As probabilidades de falha e complicações foram extraídas de uma busca nas bases PubMed e Embase, e os valores associados ao procedimento e às complicações foram extraídos de pesquisa de mercado e do Departamento de Informática do Sistema Único de Saúde (DATASUS). Cada alternativa de passagem do cateter venoso central teve um custo calculado por meio do seguimento de cada um dos possíveis caminhos da árvore de decisão. A razão de custo-efetividade incremental foi calculada considerando-se a divisão do custo incremental médio da técnica de ultrassonografia em tempo real comparada à técnica de reparos anatômicos externos pelo benefício incremental médio, em termos de complicações evitadas. Resultados: O custo final médio avaliado pela árvore de decisão, considerando a incorporação da ultrassonografia em tempo real e a redução de custo por diminuição de complicações, para a técnica de reparos anatômicos externos foi de R$262,27 e, para ultrassonografia em tempo real, de R$187,94. O custo incremental final foi de -R$74,33 por cateter venoso central. A razão de custo-efetividade incremental foi -R$2.494,34 por pneumotórax evitado. Conclusão: A inserção de cateter venoso central com auxílio de ultrassonografia em tempo real esteve associada à diminuição da taxa de falhas e complicações, além de hipoteticamente reduzir custos na perspectiva da fonte pagadora, no caso o SUS.

ABSTRACT Objective: To evaluate the cost-effectiveness, from the funding body's point of view, of real-time ultrasound-guided central venous catheter insertion compared to the traditional method, which is based on the external anatomical landmark technique. Methods: A theoretical simulation based on international literature data was applied to the Brazilian context, i.e., the Unified Health System (Sistema Único de Saúde - SUS). A decision tree was constructed that showed the two central venous catheter insertion techniques: real-time ultrasonography versus external anatomical landmarks. The probabilities of failure and complications were extracted from a search on the PubMed and Embase databases, and values associated with the procedure and with complications were taken from market research and the Department of Information Technology of the Unified Health System (DATASUS). Each central venous catheter insertion alternative had a cost that could be calculated by following each of the possible paths on the decision tree. The incremental cost-effectiveness ratio was calculated by dividing the mean incremental cost of real-time ultrasound compared to the external anatomical landmark technique by the mean incremental benefit, in terms of avoided complications. Results: When considering the incorporation of real-time ultrasound and the concomitant lower cost due to the reduced number of complications, the decision tree revealed a final mean cost for the external anatomical landmark technique of 262.27 Brazilian reals (R$) and for real-time ultrasound of R$187.94. The final incremental cost of the real-time ultrasound-guided technique was -R$74.33 per central venous catheter. The incremental cost-effectiveness ratio was -R$2,494.34 due to the pneumothorax avoided. Conclusion: Real-time ultrasound-guided central venous catheter insertion was associated with decreased failure and complication rates and hypothetically reduced costs from the view of the funding body, which in this case was the SUS.

Increased serum bicarbonate in critically ill patients: a retrospective analysis.

PURPOSE: Although metabolic alkalosis is a common occurrence, no study has evaluated its prevalence, associated factors or outcomes in critically ill patients. METHODS: This is a retrospective study from the Multiparameter Intelligent Monitoring in Intensive Care II database. From 23,529 adult patient records, 18,982 patients met the inclusion criteria. RESULTS: Serum bicarbonate levels demonstrated a U-shaped association with mortality with knots at 25 and 30 mEq/l. Of the total included patients, 5,565 (29.3 %) had at least one serum bicarbonate level measurement >30 mEq/l. The majority were exposed to multiple factors that are classically associated with metabolic alkalosis (mainly diuretic use, hypernatremia, hypokalemia and high gastric output). Patients with increased serum bicarbonate exhibited increased ICU LOS, more days on mechanical ventilation and higher hospital mortality. After multivariate adjustment, each 5-mEq/l increment in the serum bicarbonate level above 30 mEq/l was associated with an odds ratio of 1.21 for hospital mortality. The association between increased serum bicarbonate levels and mortality occurs independently of its possible etiologies. CONCLUSION: An increased serum bicarbonate level is common in critically ill patients; this can be attributed to multiple factors in the majority of cases, and its presence and duration negatively influence patient outcomes.

Implementation of a multifaceted sepsis education program in an emerging country setting: clinical outcomes and cost-effectiveness in a long-term follow-up study.

PURPOSE: To evaluate whether a multifaceted, centrally coordinated quality improvement program in a network of hospitals can increase compliance with the resuscitation bundle and improve clinical and economic outcomes in an emerging country setting. METHODS: This was a pre- and post-intervention study in ten private hospitals (1,650 beds) in Brazil (from May 2010 to January 2012), enrolling 2,120 patients with severe sepsis or septic shock. The program used a multifaceted approach: screening strategies, multidisciplinary educational sessions, case management, and continuous performance assessment. The network administration and an external consultant provided performance feedback and benchmarking within the network. The primary outcome was compliance with the resuscitation bundle. The secondary outcomes were hospital mortality, hospital and ICU length of stay, quality-adjusted life year (QALY) gain, and cost-effectiveness. RESULTS: The proportion of patients who received all the required items for the resuscitation bundle improved from 13% [95% confidence interval (CI) 8-18%] at baseline to 62% (95% CI 54-69%) in the last trimester (p < 0.001). Hospital mortality decreased from 55% (95% CI 48-62%) to 26% (95% CI 19-32%, p < 0.001). Full compliance with the resuscitation bundle was associated with lower risk of hospital mortality (propensity weighted corrected risk ratio 0.74; 95% CI 0.56-0.94, p = 0.02). There was a reduction in the total cost per patient from 29.3 (95% CI 23.9-35.4) to 17.5 (95% CI 14.3-21.1) thousand US dollars from baseline to the last 3 months (mean difference -11,815; 95% CI -18,604 to -5,338). The mean QALY increased from 2.63 (95% CI 2.15-3.14) to 4.06 (95% CI 3.58-4.57). For each QALY, the full compliance saves US$5,383. CONCLUSIONS: A multifaceted approach to severe sepsis and septic shock patients in an emerging country setting led to high compliance with the resuscitation bundle. The intervention was cost-effective and associated with a reduction in mortality.

Evaluation of a minimal sedation protocol using ICU sedative consumption as a monitoring tool: a quality improvement multicenter project.

INTRODUCTION: Oversedation frequently occurs in ICUs. We aimed to evaluate a minimal sedation policy, using sedative consumption as a monitoring tool, in a network of ICUs targeting decrement of oversedation and mechanical ventilation (MV) duration. METHODS: A prospective quality improvement project was conducted in ten ICUs within a network of nonteaching hospitals in Brazil during a 2-year period (2010 to 2012). In the first 12 months (the preintervention period), we conducted an audit to identify sedation practice and barriers to current guideline-based practice regarding sedation. In the postintervention period, we implemented a multifaceted program, including multidisciplinary daily rounds, and monthly audits focusing on sedative consumption, feedback and benchmarking purposes. To analyze the effect of the campaign, we fit an interrupted time series (ITS). To account for variability among the network ICUs, we fit a hierarchical model. RESULTS: During the study period, 21% of patients received MV (4,851/22,963). In the postintervention period, the length of MV was lower (3.91 ± 6.2 days versus 3.15 ± 4.6 days; mean difference, -0.76 (95% CI, -1.10; -0.43), P <0.001) and 28 ventilator-free days were higher (16.07 ± 12.2 days versus 18.33 ± 11.6 days; mean difference, 2.30 (95% CI, 1.57; 3.00), P <0.001) than in the preintervention period. Midazolam consumption (in milligrams per day of MV) decreased from 329 ± 70 mg/day to 163 ± 115 mg/day (mean difference, -167 (95% CI, -246; -87), P <0.001). In contrast, consumption of propofol (P = 0.007), dexmedetomidine (P = 0.017) and haloperidol (P = 0.002) increased in the postintervention period, without changes in the consumption of fentanyl. Through ITS, age (P = 0.574) and Simplified Acute Physiology Score III (P = 0.176) remained stable. The length of MV showed a secular effect (secular trend ß(1) = -0.055, P = 0.012) and a strong decrease immediately after the intervention (intervention ß(2) = -0.976, P <0.001). The impact was maintained over the course of one year, despite the waning trend for the intervention's effect (postintervention trend ß(3)= 0.039, P = 0.095). CONCLUSIONS: By using a light sedation policy in a group of nonteaching hospitals, we reproduced the benefits that have previously been demonstrated in controlled settings. Furthermore, systematic monitoring of sedative consumption should be a feasible instrument for supporting the implementation of a protocol on a large scale.

Reclassificando o espectro de pacientes septicos com o uso do lactato: sepse grave, choque criptico, choque vasoplegico e choque disoxico / Reclassifying the spectrum of septic patients using lactate: severe sepsis, cryptic shock, vasoplegic shock and dysoxic shock

Objetivo: A definição atual de sepse grave e choque séptico inclui um perfil heterogêneo de pacientes. Embora o valor prognóstico de hiperlactatemia seja bem estabelecido, ela está presente em pacientes com ou sem choque. Nosso objetivo foi comparar o prognóstico de pacientes sépticos estratificando-os segundo dois fatores: hiperlactatemia e hipotensão persistente. Métodos: Este estudo é uma análise secundária de um estudo observacional conduzido em dez hospitais no Brasil (Rede Amil - SP). Pacientes sépticos com valor inicial de lactato das primeiras 6 horas do diagnóstico foram incluídos e divididos em 4 grupos segundo hiperlactatemia (lactato >4mmol/L) e hipotensão persistente: (1) sepse grave (sem ambos os critérios); (2) choque críptico (hiperlactatemia sem hipotensão persistente); (3) choque vasoplégico (hipotensão persistente sem hiperlactatemia); e (4) choque disóxico (ambos os critérios). Resultados: Foram analisados 1.948 pacientes, e o grupo sepse grave constituiu 52% dos pacientes, seguido por 28% com choque vasoplégico, 12% choque disóxico e 8% com choque críptico. A sobrevida em 28 dias foi diferente entre os grupos (p<0,001), sendo maior para o grupo sepse grave (69%; p<0,001 versus outros), semelhante entre choque críptico e vasoplégico (53%; p=0,39) e menor para choque disóxico (38%; p<0,001 versus outros). Em análise ajustada, a sobrevida em 28 dias permaneceu diferente entre os grupos (p<0,001), sendo a maior razão de risco para o grupo choque disóxico (HR=2,99; IC95% 2,21-4,05). Conclusão: A definição de pacientes com sepse inclui quatro diferentes perfis, se considerarmos a presença de hiperlactatemia. Novos estudos são necessários para melhor caracterizar pacientes sépticos e gerar conhecimento ...

Objective: The current definition of severe sepsis and septic shock includes a heterogeneous profile of patients. Although the prognostic value of hyperlactatemia is well established, hyperlactatemia is observed in patients with and without shock. The present study aimed to compare the prognosis of septic patients by stratifying them according to two factors: hyperlactatemia and persistent hypotension. Methods: The present study is a secondary analysis of an observational study conducted in ten hospitals in Brazil (Rede Amil - SP). Septic patients with initial lactate measurements in the first 6 hours of diagnosis were included and divided into 4 groups according to hyperlactatemia (lactate >4mmol/L) and persistent hypotension: (1) severe sepsis (without both criteria); (2) cryptic shock (hyperlactatemia without persistent hypotension); (3) vasoplegic shock (persistent hypotension without hyperlactatemia); and (4) dysoxic shock (both criteria). Results: In total, 1,948 patients were analyzed, and the sepsis group represented 52% of the patients, followed by 28% with vasoplegic shock, 12% with dysoxic shock and 8% with cryptic shock. Survival at 28 days differed among the groups (p<0.001). Survival was highest among the severe sepsis group (69%, p<0.001 versus others), similar in the cryptic and vasoplegic shock groups (53%, p=0.39), and lowest in the dysoxic shock group (38%, p<0.001 versus others). In the adjusted analysis, the survival at 28 days remained different among the groups (p<0.001) and the dysoxic shock group exhibited the highest hazard ratio (HR=2.99, 95%CI 2.21-4.05). Conclusion: The definition of sepsis includes four different profiles if we consider the presence of hyperlactatemia. Further studies are needed to better characterize septic patients, to understand the etiology and to design adequate targeted treatments. .

A multicenter study using positive deviance for improving hand hygiene compliance.

BACKGROUND: Positive deviance (PD) can be a strategy for the improvement of hand hygiene (HH) compliance. METHODS: This study was conducted in 8 intensive care units and 1 ward at 7 tertiary care, private, and public hospitals. Phase 1 was a 3-month baseline period (from August to October 2011) in which HH counts were performed by observers using iPods (iScrub program). From November 2011 to July 2012, phase 2, a PD intervention was performed in all the participating centers. We evaluated the consumption of HH products (alcohol gel and chlorhexidine) and the incidence density of health care-associated infections. RESULTS: There was a total of 5,791 HH observations in the preintervention phase and 11,724 HH observations in the intervention phase (PD). A statistically significant difference was found in overall HH compliance with 46.5% in the preintervention phase and 62.0% in the PD phase (P < .001). There was a statistically significant reduction in the incidence of density of device-associated infections per 1,000 patient-days and also in the median of length of stay between the preintervention phase and the PD phase (13.2 vs 7.5 per 1,000 patient-days, respectively, P = .039; and 11.0 vs 6.8 days, respectively, P < .001, respectively). CONCLUSION: PD demonstrated great promise for improving HH in multiple inpatient settings and was associated with a decrease in the median length of stay and the incidence of device-associated HAIs.

Reclassifying the spectrum of septic patients using lactate: severe sepsis, cryptic shock, vasoplegic shock and dysoxic shock.

OBJECTIVE: The current definition of severe sepsis and septic shock includes a heterogeneous profile of patients. Although the prognostic value of hyperlactatemia is well established, hyperlactatemia is observed in patients with and without shock. The present study aimed to compare the prognosis of septic patients by stratifying them according to two factors: hyperlactatemia and persistent hypotension. METHODS: The present study is a secondary analysis of an observational study conducted in ten hospitals in Brazil (Rede Amil - SP). Septic patients with initial lactate measurements in the first 6 hours of diagnosis were included and divided into 4 groups according to hyperlactatemia (lactate >4mmol/L) and persistent hypotension: (1) severe sepsis (without both criteria); (2) cryptic shock (hyperlactatemia without persistent hypotension); (3) vasoplegic shock (persistent hypotension without hyperlactatemia); and (4) dysoxic shock (both criteria). RESULTS: In total, 1,948 patients were analyzed, and the sepsis group represented 52% of the patients, followed by 28% with vasoplegic shock, 12% with dysoxic shock and 8% with cryptic shock. Survival at 28 days differed among the groups (p<0.001). Survival was highest among the severe sepsis group (69%, p<0.001 versus others), similar in the cryptic and vasoplegic shock groups (53%, p=0.39), and lowest in the dysoxic shock group (38%, p<0.001 versus others). In the adjusted analysis, the survival at 28 days remained different among the groups (p<0.001) and the dysoxic shock group exhibited the highest hazard ratio (HR=2.99, 95%CI 2.21-4.05). CONCLUSION: The definition of sepsis includes four different profiles if we consider the presence of hyperlactatemia. Further studies are needed to better characterize septic patients, to understand the etiology and to design adequate targeted treatments.

Impact of Plasma-Lyte pH 7.4 on acid-base status and hemodynamics in a model of controlled hemorrhagic shock.

OBJECTIVE: Intravenous infusion of crystalloid solutions is a cornerstone of the treatment of hemorrhagic shock. However, crystalloid solutions can have variable metabolic acid-base effects, perpetuating or even aggravating shock-induced metabolic acidosis. The aim of this study was to compare, in a controlled volume-driven porcine model of hemorrhagic shock, the effects of three different crystalloid solutions on the hemodynamics and acid-base balance. METHODS: Controlled hemorrhagic shock (40% of the total blood volume was removed) was induced in 18 animals, which were then treated with normal saline (0.9% NaCl), Lactated Ringer's Solution or Plasma-Lyte pH 7.4, in a blinded fashion (n = 6 for each group). Using a predefined protocol, the animals received three times the volume of blood removed. RESULTS: The three different crystalloid infusions were equally capable of reversing the hemorrhage-induced low cardiac output and anuria. The Lactated Ringer's Solution and Plasma-Lyte pH 7.4 infusions resulted in an increased standard base excess and a decreased serum chloride level, whereas treatment with normal saline resulted in a decreased standard base excess and an increased serum chloride level. The Plasma-Lyte pH 7.4 infusions did not change the level of the unmeasured anions. CONCLUSION: Although the three tested crystalloid solutions were equally able to attenuate the hemodynamic and tissue perfusion disturbances, only the normal saline induced hyperchloremia and metabolic acidosis.