LUCIANO CESAR PONTES DE AZEVEDO
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LIM/51 - Laboratório de Emergências Clínicas, Hospital das Clínicas, Faculdade de Medicina
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- Association of Sepsis Diagnosis at Daytime and on Weekdays with Compliance with the 3-Hour Sepsis Treatment Bundles A Multicenter Cohort Study(2020) RANZANI, Otavio T.; MONTEIRO, Mariana Barbosa; BESEN, Bruno Adler Maccagnan Pinheiro; AZEVEDO, Luciano Cesar PontesRationale: Compliance with sepsis bundles is associated with better outcomes, but information to support structural actions that might improve compliance is scarce. Few studies have evaluated bundle compliance in different time periods, with conflicting results. Objectives: To evaluate the association of sepsis identification during the daytime versus during the nighttime and on weekdays versus weekends with 3-hour sepsis treatment bundle compliance. Methods: This was an observational, multicenter study including patients with sepsis admitted between 2010 and 2017 to 10 hospitals in Brazil. Our exposures of interest were daytime (7:00 A.M.-6:59 P.M.) versus nighttime (7:00 P.M.-6:59 A.M.) and weekdays (Monday 7:00 A.M.-Friday 6:59 P.M.) versus weekends (Friday 7:00 P.M.-Monday 659 A.M.). Our primary outcome was full compliance with the 3-hour sepsis treatment bundles. We adjusted by potential confounding factors with multivariable logistic regression models. Results: Of 11,737 patients (8,733 sepsis and 3,004 septic shock), 3-hour bundle compliance was 79.1% and hospital mortality was 24.7%. The adjusted odds ratio (adjOR) for 3-hour full bundle compliance for patients diagnosed during the daytime versus during the nighttime was 1.35 (95% confidence interval [CI), 1.23-1.49; P < 0.001) and was more pronounced in the emergency department (adjOR, 1.55; 95% CI, 1.35 1.77; P < 0.001) than in nonemergency areas (adjOR, 1.19; 95% CI, 1.04-1.37; P = 0.014). Overall, there was no association between diagnosis on the weekends versus on weekdays and 3-hour full bundle compliance (adjOR, 1.08; 95% CI, 0.98-1.19; P = 0.115), although there was an association among those diagnosed in nonemergency areas (adjOR, 1.15; 95% CI, 1.00-1.32; P = 0.047). The lower compliance observed for sepsis diagnosed during the nighttime was more evident 2 years after implementation of the quality improvement initiative. Conclusions: Compliance with sepsis bundles was associated with the moment of sepsis diagnosis. The place of diagnosis and the time from campaign implementation were factors modifying this association. Our results support areas for better design of quality improvement initiatives to mitigate the influence of the period of sepsis diagnosis on treatment compliance.
- Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19 A Meta-analysis(2020) STERNE, Jonathan A. C.; MURTHY, Srinivas; V, Janet Diaz; SLUTSKY, Arthur S.; VILLAR, Jesus; ANGUS, Derek C.; ANNANE, Djillali; AZEVEDO, Luciano Cesar Pontes; BERWANGER, Otavio; CAVALCANTI, Alexandre B.; DEQUIN, Pierre-Francois; DU, Bin; EMBERSON, Jonathan; FISHER, David; GIRAUDEAU, Bruno; GORDON, Anthony C.; GRANHOLM, Anders; GREEN, Cameron; HAYNES, Richard; HEMING, Nicholas; HIGGINS, Julian P. T.; HORBY, Peter; JUNI, Peter; LANDRAY, Martin J.; GOUGE, Amelie Le; LECLERC, Marie; LIM, Wei Shen; MACHADO, Flavia R.; MCARTHUR, Colin; MEZIANI, Ferhat; MOLLER, Morten Hylander; PERNER, Anders; PETERSEN, Marie Warrer; SAVOVIC, Jelena; TOMAZINI, Bruno; VEIGA, Viviane C.; WEBB, Steve; MARSHALL, John C.IMPORTANCE Effective therapies for patients with coronavirus disease 2019 (COVID-19) are needed, and clinical trial data have demonstrated that low-dose dexamethasone reduced mortality in hospitalized patients with COVID-19 who required respiratory support. OBJECTIVE To estimate the association between administration of corticosteroids compared with usual care or placebo and 28-day all-cause mortality. DESIGN, SETTING, AND PARTICIPANTS Prospective meta-analysis that pooled data from 7 randomized clinical trials that evaluated the efficacy of corticosteroids in 1703 critically ill patients with COVID-19. The trials were conducted in 12 countries from February 26, 2020, to June 9, 2020, and the date of final follow-up was July 6, 2020. Pooled data were aggregated from the individual trials, overall, and in predefined subgroups. Risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I-2 statistic. The primary analysis was an inverse variance-weighted fixed-effect meta-analysis of overall mortality, with the association between the intervention and mortality quantified using odds ratios (ORs). Random-effects meta-analyses also were conducted (with the Paule-Mandel estimate of heterogeneity and the Hartung-Knapp adjustment) and an inverse variance-weighted fixed-effect analysis using risk ratios. EXPOSURES Patients had been randomized to receive systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo (1025 patients). MAIN OUTCOMES AND MEASURES The primary outcome measure was all-cause mortality at 28 days after randomization. A secondary outcome was investigator-defined serious adverse events. RESULTS A total of 1703 patients (median age, 60 years [interquartile range, 52-68 years]; 488 [29%] women) were included in the analysis. Risk of bias was assessed as ""low"" for 6 of the 7 mortality results and as ""some concerns"" in 1 trial because of the randomization method. Five trials reported mortality at 28 days, 1 trial at 21 days, and 1 trial at 30 days. There were 222 deaths among the 678 patients randomized to corticosteroids and 425 deaths among the 1025 patients randomized to usual care or placebo (summary OR, 0.66 [95% CI, 0.53-0.82]; P < .001 based on a fixed-effect meta-analysis). There was little inconsistency between the trial results (I-2 = 15.6%; P = .31 for heterogeneity) and the summary OR was 0.70 (95% CI, 0.48-1.01; P = .053) based on the random-effects meta-analysis. The fixed-effect summary OR for the association with mortality was 0.64 (95% CI, 0.50-0.82; P < .001) for dexamethasone compared with usual care or placebo (3 trials, 1282 patients, and 527 deaths), the OR was 0.69 (95% CI, 0.43-1.12; P = .13) for hydrocortisone (3 trials, 374 patients, and 94 deaths), and the OR was 0.91 (95% CI, 0.29-2.87; P = .87) for methylprednisolone (1 trial, 47 patients, and 26 deaths). Among the 6 trials that reported serious adverse events, 64 events occurred among 354 patients randomized to corticosteroids and 80 events occurred among 342 patients randomized to usual care or placebo. CONCLUSIONS AND RELEVANCE In this prospective meta-analysis of clinical trials of critically ill patients with COVID-19, administration of systemic corticosteroids, compared with usual care or placebo, was associated with lower 28-day all-cause mortality.
- Diretrizes para o tratamento farmacológico da COVID-19. Consenso da Associação de Medicina Intensiva Brasileira, da Sociedade Brasileira de Infectologia e da Sociedade Brasileira de Pneumologia e Tisiologia(2020) FALAVIGNA, Maicon; COLPANI, Verônica; STEIN, Cinara; AZEVEDO, Luciano Cesar Pontes; BAGATTINI, Angela Maria; BRITO, Gabriela Vilela de; CHATKIN, José Miguel; CIMERMAN, Sergio; CORRADI, Mirian de Freitas Dal Ben; CUNHA, Clovis Arns da; MEDEIROS, Flávia Cordeiro de; OLIVEIRA JUNIOR, Haliton Alves de; FRITSCHER, Leandro Genehr; GAZZANA, Marcelo Basso; GRäF, Débora Dalmas; MARRA, Lays Pires; MATUOKA, Jessica Yumi; NUNES, Michelle Silva; PACHITO, Daniela Vianna; PAGANO, Cássia Garcia Moraes; PARREIRA, Patrícia do Carmo Silva; RIERA, Rachel; SILVA JÚNIOR, Amilton; TAVARES, Bruno de Melo; ZAVASCKI, Alexandre Prehn; ROSA, Regis Goulart; DAL-PIZZOL, FelipeABSTRACT Introduction: Different therapies are currently used, considered, or proposed for the treatment of COVID-19; for many of those therapies, no appropriate assessment of effectiveness and safety was performed. This document aims to provide scientifically available evidence-based information in a transparent interpretation, to subsidize decisions related to the pharmacological therapy of COVID-19 in Brazil. Methods: A group of 27 experts and methodologists integrated a task-force formed by professionals from the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB), the Brazilian Society of Infectious Diseases (Sociedad Brasileira de Infectologia - SBI) and the Brazilian Society of Pulmonology and Tisiology (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT). Rapid systematic reviews, updated on April 28, 2020, were conducted. The assessment of the quality of evidence and the development of recommendations followed the GRADE system. The recommendations were written on May 5, 8, and 13, 2020. Results: Eleven recommendations were issued based on low or very-low level evidence. We do not recommend the routine use of hydroxychloroquine, chloroquine, azithromycin, lopinavir/ritonavir, corticosteroids, or tocilizumab for the treatment of COVID-19. Prophylactic heparin should be used in hospitalized patients, however, no anticoagulation should be provided for patients without a specific clinical indication. Antibiotics and oseltamivir should only be considered for patients with suspected bacterial or influenza coinfection, respectively. Conclusion: So far no pharmacological intervention was proven effective and safe to warrant its use in the routine treatment of COVID-19 patients; therefore such patients should ideally be treated in the context of clinical trials. The recommendations herein provided will be revised continuously aiming to capture newly generated evidence.
- Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19 The CoDEX Randomized Clinical Trial(2020) TOMAZINI, Bruno M.; MAIA, Israel S.; CAVALCANTI, Alexandre B.; BERWANGER, Otavio; ROSA, Regis G.; VEIGA, Viviane C.; AVEZUM, Alvaro; LOPES, Renato D.; BUENO, Flavia R.; SILVA, Maria Vitoria A. O.; BALDASSARE, Franca P.; V, Eduardo L. Costa; MOURA, Ricardo A. B.; HONORATO, Michele O.; COSTA, Andre N.; DAMIANI, Lucas P.; LISBOA, Thiago; KAWANO-DOURADO, Leticia; ZAMPIERI, Fernando G.; OLIVATO, Guilherme B.; RIGHY, Cassia; AMENDOLA, Cristina P.; ROEPKE, Roberta M. L.; FREITAS, Daniela H. M.; FORTE, Daniel N.; FREITAS, Flavio G. R.; FERNANDES, Caio C. F.; MELRO, Livia M. G.; JUNIOR, Gedealvares F. S.; MORAIS, Douglas Costa; ZUNG, Stevin; MACHADO, Flavia R.; AZEVEDO, Luciano C. P.IMPORTANCE Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients. OBJECTIVE To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS. DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients. INTERVENTIONS Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n = 151) or standard care alone (n = 148). MAIN OUTCOMES AND MEASURES The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days. RESULTS A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P =.04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events. CONCLUSIONS AND RELEVANCE Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days.
- Approaching COVID-19-Bedside strategies for intensive care(2020) BETONICO, Gustavo Navarro; AZEVEDO, Luciano Cesar
- Epidemiology, outcomes, and the use of intensive care unit resources of critically ill patients diagnosed with COVID-19 in Sao Paulo, Brazil: A cohort study(2020) SOCOLOVITHC, Rachel Lane; FUMIS, Renata Rego Lins; TOMAZINI, Bruno Martins; PASTORE, Laerte; GALAS, Filomena Regina Barbosa Gomes; AZEVEDO, Luciano Cesar Pontes de; COSTA, Eduardo Leite VieiraBackground The coronavirus disease (COVID-19) pandemic has brought significant challenges worldwide, with high mortality, increased use of hospital resources, and the collapse of healthcare systems. We aimed to describe the clinical outcomes of critically ill COVID-19 patients and assess the impact on the use of hospital resources and compare with critically ill medical patients without COVID-19. Methods and findings In this retrospective cohort study, we included patients diagnosed with COVID-19 admitted to a private ICU in Sao Paulo, Brazil from March to June 2020. We compared these patients with those admitted to the unit in the same period of the previous year. A total of 212 consecutive patients with a confirmed diagnosis of COVID-19 were compared with 185 medical patients from the previous year. Patients with COVID-19 were more frequently males (76% vs. 56%, p<0.001) and morbidly obese (7.5% vs. 2.2%, p = 0.027), and had lower SAPS 3 (49.65 (12.19) vs. 55.63 (11.94), p<0.001) and SOFA scores (3.78 (3.53) vs. 4.48 (3.11), p = 0.039). COVID-19 patients had a longer ICU stay (median of 7 vs. 3 days, p<0.001), longer duration of mechanical ventilation (median of 9 vs. 4 days, p = 0.003), and more frequent tracheostomies (10.8 vs. 1.1%, p<0.001). Survival rates until 28 days were not statistically different (91% vs. 85.4%, p = 0.111). After multivariable adjustment for age, gender, SAPS 3, and Charlson Comorbidity Index, COVID-19 remained not associated with survival at 28 days (HR 0.59, 95% CI 0.33-1.06, p = 0.076). Among patients who underwent invasive mechanical ventilation, the observed mortality at 28-days was 16.2% in COVID-19 patients compared to 34.6% in the previous year. Conclusions COVID-19 required more hospital resources, including invasive and non-invasive ventilation, had a longer duration of mechanical ventilation, and a more prolonged ICU and hospital length of stay. There was no difference in all-cause mortality at 28 and 60 days, suggesting that health systems preparedness be an important determinant of clinical outcomes.
bookPart Suporte extracorpóreo cardiovascular e respiratório(2020) PARK, Marcelo; AZEVEDO, Luciano César Pontes de; COSTA, Eduardo Leite Vieira- Práticas de promoção de sono em unidades de terapia intensiva no Brasil: um inquérito nacional(2020) RAMOS, Fernando José da Silva; TANIGUCHI, Leandro Utino; AZEVEDO, Luciano Cesar Pontes deABSTRACT Objective: To conduct a national survey of intensive care professionals to identify the practices for promoting sleep in adult intensive care units in Brazil and describe the professionals’ perceptions of the importance of sleep for patients. Methods: An electronic questionnaire was distributed by the clinical research cooperation network of the Associação de Medicina Intensiva Brasileira and by the Brazilian Research in Intensive Care Network to physicians and nurses registered with the association. The questionnaire evaluated the profile of the respondents, the profile of their intensive care units, whether protocols for promoting sleep were present, the pharmacological and nonpharmacological measures typically employed in the unit, and the professionals’ perceptions regarding sleep in critically ill patients. Results: A total of 118 questionnaires were evaluated. The Southeast region of the country was the most represented (50 questionnaires, 42.4%). The majority of units had a clinical-surgical profile (93 questionnaires; 78.8%), and 26 had a continuous visitation policy (22.0%). Only 18 intensive care units (15.3%) reported having protocols for promoting sleep. The most cited measure for sleep promotion was reducing light during the night (95 questionnaires; 80.5%), which was more often performed in private intensive care units. Almost all of the responders (99%) believed that poor-quality sleep has a negative impact on patient recovery. Conclusion: The responses to this Brazilian survey revealed that few intensive care units had a program for promoting sleep, although almost all participants recognized the importance of sleep in patient recovery.
- Comparison of two frailty identification tools for critically ill patients: A post-hoc analysis of a multicenter prospective cohort study(2020) TANIGUCHI, Leandro Utino; IBRAHIM, Quazi; AZEVEDO, Luciano Cesar Pontes de; STELFOX, Henry T.; BAGSHAW, Sean M.Purpose: We aimed to describe the association of two frailty screening tools, the validated Clinical Frailty Scale (CFS) score and the recently described modified Frailty Index (mFI) in critically ill patients. Materials and methods: We performed a post-hoc analysis of a multicenter cohort of patients admitted to six Canadian Intensive Care Units (ICU) between 2010 and 2011. Frailty was screened using the CFS and the mFI. Concordance between these tools was evaluated, as well as discrimination and predictive ability for clinical outcomes after adjustments. Results: The cohort included 421 patients. Prevalence of frailty was 32.8% with the CFS and 39.2% with the mFI. However, concordance between the two tools was low [(intraclass correlation of 037; 95% confidence interval [CI] 0.29-0.45) and partial Spearman rank correlation of 038 (95% CI 029-0.47)]. Hospital and 1-year mortality, as well as dependency after discharge and hospital readmission, were greater for frail compared to non-frail patients screened with the use of both tools. Conclusion: While the CFS and mFI showed low concordance, both showed good discrimination and predictive validity for hospital mortality. Both tools identify a subgroup of frail patients more likely to have worse clinical outcomes.
- Síndrome do desconforto respiratório agudo associada à COVID-19 tratada com DEXametasona (CoDEX): delineamento e justificativa de um estudo randomizado(2020) TOMAZINI, Bruno Martins; MAIA, Israel Silva; BUENO, Flavia Regina; SILVA, Maria Vitoria Aparecida Oliveira; BALDASSARE, Franca Pellison; COSTA, Eduardo Leite Vieira; MOURA, Ricardo Antonio Bonifácio; HONORATO, Michele Ouriques; COSTA, André Nathan; CAVALCANTI, Alexandre Biasi; ROSA, Regis Goulart; AVEZUM, Álvaro; VEIGA, Viviane Cordeiro; LOPES, Renato Delascio; DAMIANI, Lucas Petri; MACHADO, Flávia Ribeiro; BERWANGER, Otavio; AZEVEDO, Luciano César Pontes deAbstract Objective: The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV-2 infection (coronavirus disease 2019 - COVID-19) is viral pneumonia with varying degrees of respiratory compromise and up to 40% of hospitalized patients might develop acute respiratory distress syndrome. Several clinical trials evaluated the role of corticosteroids in non-COVID-19 acute respiratory distress syndrome with conflicting results. We designed a trial to evaluate the effectiveness of early intravenous dexamethasone administration on the number of days alive and free of mechanical ventilation within 28 days after randomization in adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19. Methods: This is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19. Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group). Patients in the intervention group will receive dexamethasone 20mg intravenous once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until intensive care unit discharge, whichever occurs first. The primary outcome is ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation. Secondary outcomes are all-cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation at 48 hours, 72 hours and 7 days and intensive care unit -free days within 28.