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Importance: Despite its implementation in several countries, there has not been a randomized clinical trial to assess whether telemedicine in intensive care units (ICUs) could improve clinical outcomes of critically ill patients., Objective: To determine whether an intervention comprising daily multidisciplinary rounds and monthly audit and feedback meetings performed by a remote board-certified intensivist reduces ICU length of stay (LOS) compared with usual care., Design, Setting, and Participants: A parallel cluster randomized clinical trial with a baseline period in 30 general ICUs in Brazil in which daily multidisciplinary rounds performed by board-certified intensivists were not routinely available. All consecutive adult patients (aged ≥18 years) admitted to the participating ICUs, excluding those admitted due to justice-related issues, were enrolled between June 1, 2019, and April 7, 2021, with last follow-up on July 6, 2021., Intervention: Remote daily multidisciplinary rounds led by a board-certified intensivist through telemedicine, monthly audit and feedback meetings for discussion of ICU performance indicators, and provision of evidence-based clinical protocols., Main Outcomes and Measures: The primary outcome was ICU LOS at the patient level. Secondary outcomes included ICU efficiency, in-hospital mortality, incidence of central line-associated bloodstream infections, ventilator-associated events, catheter-associated urinary tract infections, ventilator-free days at 28 days, patient-days receiving oral or enteral feeding, patient-days under light sedation, and rate of patients with oxygen saturation values under that of normoxemia, assessed using generalized linear mixed models., Results: Among 17 024 patients (1794 in the baseline period and 15 230 in the intervention period), the mean (SD) age was 61 (18) years, 44.7% were female, the median (IQR) Sequential Organ Failure Assessment score was 6 (2-9), and 45.5% were invasively mechanically ventilated at admission. The median (IQR) time under intervention was 20 (16-21) months. Mean (SD) ICU LOS, adjusted for baseline assessment, did not differ significantly between the tele-critical care and usual care groups (8.1 [10.0] and 7.1 [9.0] days; percentage change, 8.2% [95% CI, -5.4% to 23.8%]; P = .24). Results were similar in sensitivity analyses and prespecified subgroups. There were no statistically significant differences in any other secondary or exploratory outcomes., Conclusions and Relevance: Daily multidisciplinary rounds conducted by a board-certified intensivist through telemedicine did not reduce ICU LOS in critically ill adult patients., Trial Registration: ClinicalTrials.gov Identifier: NCT03920501.

Background: Neoadjuvant radiation and oxaliplatin-based systemic therapy (total neoadjuvant therapy-TNT) have been shown to increase response and organ-preservation rates in localized rectal cancer. However, trials have been heterogeneous regarding treatment protocols and few have used a watch-and-wait (WW) approach for complete responders. This trial evaluates if conventional long-term chemoradiation followed by consolidation of FOLFIRINOX increases complete response rates and the number of patients managed by WW., Methods: This was a pragmatic randomized phase II trial conducted in 2 Cancer Centers in Brazil that included patients with T3+ or N+ rectal adenocarcinoma. After completing a long-course 54 Gy chemoradiation with capecitabine patients were randomized 1:1 to 4 cycles of mFOLFIRINOX (Oxaliplatin 85, irinotecan 150, 5-FU 2400)-TNT-arm-or to the control arm, that did not include further neoadjuvant treatment. All patients were re-staged with dedicated pelvic magnetic resonance imaging and sigmoidoscopy 12 weeks after the end of radiation. Patients with a clinical complete response were followed using a WW protocol. The primary endpoint was complete response: clinical complete response (cCR) or pathological response (pCR)., Results: Between April 2021 and June 2023, 55 patients were randomized to TNT and 53 to the control arm. Tumors were 74% stage 3, median distance from the anal verge was 6 cm, 63% had an at-risk circumferential margin, and 33% an involved sphincter. The rates of cCR + pCR were (31%) for TNT versus (17%) for controls (odds ratio 2.19, CI 95% 0.8-6.22 P = .091) and rates of WW were 16% and 9% (P = ns). Median follow-up was 8.1 months and recurrence rates were 16% versus 21% for TNT and controls (P = ns)., Conclusions: TNT with consolidation FOLFIRINOX is feasible and has high response rates, consistent with the current literature for TNT. This trial was supported by a grant from the Brazilian Government (PROADI-SUS - NUP 25000.164382/2020-81)., Competing Interests: Disclosure The authors have stated that they have no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: To determine risk factors for the development of long coronavirus disease 2019 (COVID-19) in healthcare personnel (HCP)., Methods: We conducted a case-control study among HCP who had confirmed symptomatic COVID-19 working in a Brazilian healthcare system between March 1, 2020, and July 15, 2022. Cases were defined as those having long COVID according to the Centers for Disease Control and Prevention definition. Controls were defined as HCP who had documented COVID-19 but did not develop long COVID. Multiple logistic regression was used to assess the association between exposure variables and long COVID during 180 days of follow-up., Results: Of 7,051 HCP diagnosed with COVID-19, 1,933 (27.4%) who developed long COVID were compared to 5,118 (72.6%) who did not. The majority of those with long COVID (51.8%) had 3 or more symptoms. Factors associated with the development of long COVID were female sex (OR, 1.21; 95% CI, 1.05-1.39), age (OR, 1.01; 95% CI, 1.00-1.02), and 2 or more SARS-CoV-2 infections (OR, 1.27; 95% CI, 1.07-1.50). Those infected with the SARS-CoV-2 δ (delta) variant (OR, 0.30; 95% CI, 0.17-0.50) or the SARS-CoV-2 o (omicron) variant (OR, 0.49; 95% CI, 0.30-0.78), and those receiving 4 COVID-19 vaccine doses prior to infection (OR, 0.05; 95% CI, 0.01-0.19) were significantly less likely to develop long COVID., Conclusions: Long COVID can be prevalent among HCP. Acquiring >1 SARS-CoV-2 infection was a major risk factor for long COVID, while maintenance of immunity via vaccination was highly protective.

Objective: To evaluate outcomes of vascular surgeries and identify strategies to improve public vascular care., Methods: This was a descriptive, qualitative, and cross-sectional survey involving 30 specialists of the Hospital Israelita Albert Einstein via Zoom. The outcomes of vascular procedures performed in the Public Health System extracted through Big Data analysis were discussed, and 53 potential strategies to improve public vascular care to improve public vascular care., Results: There was a consensus on mandatory reporting of some key complications after complex arterial surgeries, such as stroke after carotid revascularization and amputations after lower limb revascularization. Participants agreed on the recommendation of screening for diabetic feet and infrarenal abdominal aortic aneurysms. The use of Telemedicine as a tool for patient follow-up, auditing of centers for major arterial surgeries, and the concentration of complex arterial surgeries in reference centers were also points of consensus, as well as the need to reduce the values of endovascular materials. Regarding venous surgery, it was suggested that there should be incentives for simultaneous treatment of both limbs in cases of varicose veins of the lower limbs, in addition to the promotion of ultrasound-guided foam sclerotherapy in the public system., Conclusion: After discussing the data from the Brazilian Public System, proposals were defined for standardizing measures in population health care in the area of vascular surgery. Notification of complications of arterial surgeries is essential in identifying strategies to improve surgical outcomes. Screening of prevalent and/or morbid diseases allows early intervention and prevention of complications. Use of telemedicine in vascular follow-up allows optimizing the use of resources and reducing the burden on health services. Concentrating complex cases in reference hospitals leads to improved surgical outcomes.

Objective: To compare the long-term vaccine effectiveness between those receiving viral vector [Oxford-AstraZeneca (ChAdOx1)] or inactivated viral (CoronaVac) primary series (2 doses) and those who received an mRNA booster (Pfizer/BioNTech) (the third dose) among healthcare workers (HCWs)., Methods: We conducted a retrospective cohort study among HCWs (aged ≥18 years) in Brazil from January 2021 to July 2022. To assess the variation in the effectiveness of booster dose over time, we estimated the effectiveness rate by taking the log risk ratio as a function of time., Results: Of 14,532 HCWs, coronavirus disease 2019 (COVID-19) was confirmed in 56.3% of HCWs receiving 2 doses of CoronaVac vaccine versus 23.2% of HCWs receiving 2 doses of CoronaVac vaccine with mRNA booster ( P < .001), and 37.1% of HCWs receiving 2 doses of ChAdOx1 vaccine versus 22.7% among HCWs receiving 2 doses of ChAdOx1 vaccine with mRNA booster ( P < .001). The highest vaccine effectiveness with mRNA booster was observed 30 days after vaccination: 91% for the CoronaVac vaccine group and 97% for the ChAdOx1 vaccine group. Vacine effectiveness declined to 55% and 67%, respectively, at 180 days. Of 430 samples screened for mutations, 49.5% were SARS-CoV-2 delta variants and 34.2% were SARS-CoV-2 omicron variants., Conclusions: Heterologous COVID-19 vaccines were effective for up to 180 days in preventing COVID-19 in the SARS-CoV-2 delta and omicron variant eras, which suggests the need for a second booster., Competing Interests: All authors report no conflict of interest relevant to this article., (© The Author(s) 2023.)

Background: Little is currently known about vaccine effectiveness (VE) for either 2 doses of Oxford-AstraZeneca (ChAdOx1) viral vector vaccine or CoronaVac (Instituto Butantan) inactivated viral vaccine followed by a third dose of mRNA vaccine (Pfizer/BioNTech) among healthcare workers (HCWs)., Methods: We conducted a retrospective cohort study among HCWs (aged ≥18 years) working in a private healthcare system in Brazil from January to December 2021. VE was defined as 1 - incidence rate ratio (IRR), with IRR determined using Poisson models with the occurrence of laboratory-confirmed coronavirus disease 2019 (COVID-19) infection as the outcome, adjusting for age, sex, and job type. We compared those receiving viral vector or inactivated viral primary series (2 doses) with those who received an mRNA booster., Results: A total of 11 427 HCWs met the inclusion criteria. COVID-19 was confirmed in 31.5% of HCWs receiving 2 doses of CoronaVac vaccine versus 0.9% of HCWs receiving 2 doses of CoronaVac vaccine with mRNA booster (P < .001) and 9.8% of HCWs receiving 2 doses of ChAdOx1 vaccine versus 1% among HCWs receiving 2 doses of ChAdOx1 vaccine with mRNA booster (P < .001). In the adjusted analyses, the estimated VE was 92.0% for 2 CoronaVac vaccines plus mRNA booster and 60.2% for 2 ChAdOx1 vaccines plus mRNA booster, when compared with those with no mRNA booster. Of 246 samples screened for mutations, 191 (77.6%) were Delta variants., Conclusions: While 2 doses of ChAdOx1 or CoronaVac vaccines prevent COVID-19, the addition of a Pfizer/BioNTech booster provided significantly more protection., Competing Interests: Potential conflicts of interest. A. L. B. reports the following contracts or grants unrelated to this work: MCTIC/CNPq/FNDCT/MS/SCTIE/Decit 07/2020, Brazil. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: We investigated real-world vaccine effectiveness for Oxford-AstraZeneca (ChAdOx1) and CoronaVac against laboratory-confirmed severe acute respiratory coronavirus virus 2 (SARS-CoV-2) infection among healthcare workers (HCWs)., Methods: We conducted a retrospective cohort study among HCWs (aged ≥18 years) working in a private healthcare system in Brazil between January 1, 2021 and August 3, 2021, to assess vaccine effectiveness. We calculated vaccine effectiveness as 1 - rate ratio (RR), with RR determined by adjusting Poisson models with the occurrence of SARS-CoV-2 infection as the outcome and the vaccination status as the main variable. We used the logarithmic link function and simple models adjusting for sex, age, and job types., Results: In total, 13,813 HCWs met the inclusion criteria for this analysis. Among them, 6,385 (46.2%) received the CoronaVac vaccine, 5,916 (42.8%) received the ChAdOx1 vaccine, and 1,512 (11.0%) were not vaccinated. Overall, COVID-19 occurred in 6% of unvaccinated HCWs, 3% of HCWs who received 2 doses of CoronaVac vaccine, and 0.7% of HCWs who received 2 doses of ChAdOx1 vaccine ( P < .001). In the adjusted analyses, the estimated vaccine effectiveness rates were 51.3% for CoronaVac, and 88.1% for ChAdOx1 vaccine. Both vaccines reduced the number of hospitalizations, the length of hospital stay, and the need for mechanical ventilation. In addition, 19 SARS-CoV-2 samples from 19 HCWs were screened for mutations of interest. Of 19 samples, 18 were the γ (gamma) variant., Conclusions: Although both COVID-19 vaccines (viral vector and inactivated virus) can significantly prevent COVID-19 among HCWs, CoronaVac was much less effective. The COVID-19 vaccines were also effective against the dominant γ variant.

Background: The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19., Methods: We did an open-label, randomised clinical trial at 57 centres in Brazil. We enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation; or use of invasive mechanical ventilation. Patients were randomly assigned (1:1) to azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides. All patients received hydroxychloroquine (400 mg twice daily for 10 days) because that was part of standard of care treatment in Brazil for patients with severe COVID-19. The primary outcome, assessed by an independent adjudication committee masked to treatment allocation, was clinical status at day 15 after randomisation, assessed by a six-point ordinal scale, with levels ranging from 1 to 6 and higher scores indicating a worse condition (with odds ratio [OR] greater than 1·00 favouring the control group). The primary outcome was assessed in all patients in the intention-to-treat (ITT) population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation (ie, modified ITT [mITT] population). Safety was assessed in all patients according to which treatment they received, regardless of original group assignment. This trial was registered at ClinicalTrials.gov, NCT04321278., Findings: 447 patients were enrolled from March 28 to May 19, 2020. COVID-19 was confirmed in 397 patients who constituted the mITT population, of whom 214 were assigned to the azithromycin group and 183 to the control group. In the mITT population, the primary endpoint was not significantly different between the azithromycin and control groups (OR 1·36 [95% CI 0·94-1·97], p=0·11). Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups., Interpretation: In patients with severe COVID-19, adding azithromycin to standard of care treatment (which included hydroxychloroquine) did not improve clinical outcomes. Our findings do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe COVID-19., Funding: COALITION COVID-19 Brazil and EMS., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Discussions about invasiveness of care (advanced directives) and end-of-life issues have become frequent among intensivists and patients. Nevertheless, there are considerable divergences in the attitudes between intensivists and patients toward end-of-life care in the intensive care units (ICU)., Methods: The goal was to compare the preferences between intensivists and general public regarding ICU admission of a hypothetical patient with six different clinical outcomes. For that, intensivists and the general public (university graduate professionals outside the area of health) were invited to participate in this study. A survey was conducted with a hypothetical patient with six different clinical outcomes ranging from ICU discharge without any neurological sequelae, nor dependence for daily activities, to death. The WHOQOL-BREF was applied. Comparisons were made between the answers provided by intensivists regarding what they would choose for themselves and their patients, and the preferences of general public., Results: Between July 2013 and July 2016, 300 participants in 5 hospitals in São Paulo, Brazil were invited to participate in this study, of whom 257 (85.7%) responded the survey. Eighty-two intensivists responded what they would choose for themselves, 81 intensivists responded what they would choose for their patients, and 94 people from general public responded what they would choose for themselves. Quality of life did not differ among the groups. In all scenarios, except when the outcome was severe disability or death, intensivists were more likely to choose ICU admission for their patients than for themselves (p < .05 for all). Compared with general public, intensivists were more likely to choose ICU admission for themselves only when the best clinical scenario outcome is considered (p < .001). General public was significantly less prone to choosing ICU admission than intensivists when choosing for their patients, in three out of six scenarios (p < .001 for all)., Conclusions: Considerable divergences exist between intensivists' and patients' preferences toward end-of-life care. Advanced care planning and effective ongoing communication among intensivists, patients and relatives are essential to improve end-of-life decisions and the quality of care., (Copyright © 2019. Published by Elsevier Inc.)

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., Competing Interests: The authors have declared that no competing interests exist.

Purpose: Mechanical power (MP) may unify variables known to be related to development of ventilator-induced lung injury. The aim of this study is to examine the association between MP and mortality in critically ill patients receiving invasive ventilation for at least 48 h., Methods: This is an analysis of data stored in the databases of the MIMIC-III and eICU. Critically ill patients receiving invasive ventilation for at least 48 h were included. The exposure of interest was MP. The primary outcome was in-hospital mortality., Results: Data from 8207 patients were analyzed. Median MP during the second 24 h was 21.4 (16.2-28.1) J/min in MIMIC-III and 16.0 (11.7-22.1) J/min in eICU. MP was independently associated with in-hospital mortality [odds ratio per 5 J/min increase (OR) 1.06 (95% confidence interval (CI) 1.01-1.11); p = 0.021 in MIMIC-III, and 1.10 (1.02-1.18); p = 0.010 in eICU]. MP was also associated with ICU mortality, 30-day mortality, and with ventilator-free days, ICU and hospital length of stay. Even at low tidal volume, high MP was associated with in-hospital mortality [OR 1.70 (1.32-2.18); p < 0.001] and other secondary outcomes. Finally, there is a consistent increase in the risk of death with MP higher than 17.0 J/min., Conclusion: High MP of ventilation is independently associated with higher in-hospital mortality and several other outcomes in ICU patients receiving invasive ventilation for at least 48 h.

The pathophysiological mechanisms associated with the effects of red blood cell (RBC) transfusion on cardiopulmonary function and inflammation are unclear. We developed an experimental model of homologous 14-days stored RBC transfusion in hypovolemic swine to evaluate the short-term effects of transfusion on cardiopulmonary system and inflammation. Sixteen healthy male anesthetized swine (68±3.3 kg) were submitted to controlled hemorrhage (25% of blood volume). Two units of non-filtered RBC from each animal were stored under blood bank conditions for 14 days. After 30 min of hypovolemia, the control group (n=8) received an infusion of lactated Ringer's solution (three times the removed volume). The transfusion group (n=8) received two units of homologous 14-days stored RBC and lactated Ringer's solution in a volume that was three times the difference between blood removed and blood transfusion infused. Both groups were followed up for 6 h after resuscitation with collection of hemodynamic and respiratory data. Cytokines and RNA expression were measured in plasma and lung tissue. Stored RBC transfusion significantly increased mixed oxygen venous saturation and arterial oxygen content. Transfusion was not associated with alterations on pulmonary function. Pulmonary concentrations of cytokines were not different between groups. Gene expression for lung cytokines demonstrated a 2-fold increase in mRNA level for inducible nitric oxide synthase and a 0.5-fold decrease in mRNA content for IL-21 in the transfused group. Thus, stored homologous RBC transfusion in a hypovolemia model improved cardiovascular parameters but did not induce significant effects on microcirculation, pulmonary inflammation and respiratory function up to 6 h after transfusion.

Rationale: Readmission to the intensive care unit (ICU) is associated with poor clinical outcomes, increased length of ICU and hospital stay, and higher costs. Nevertheless, knowledge of epidemiology of ICU readmissions, risk factors, and attributable outcomes is restricted to developed countries., Objectives: To determine the effect of ICU readmissions on in-hospital mortality, determine incidence of ICU readmissions, identify predictors of ICU readmissions and hospital mortality, and compare resource use and outcomes between readmitted and nonreadmitted patients in a developing country., Methods: This retrospective single-center cohort study was conducted in a 40-bed, open medical-surgical ICU of a private, tertiary care hospital in São Paulo, Brazil. The Local Ethics Committee at Hospital Israelita Albert Einstein approved the study protocol, and the need for informed consent was waived. All consecutive adult (≥18 yr) patients admitted to the ICU between June 1, 2013 and July 1, 2015 were enrolled in this study., Results: Comparisons were made between patients readmitted and not readmitted to the ICU. Logistic regression analyses were performed to identify predictors of ICU readmissions and hospital mortality. Out of 5,779 patients admitted to the ICU, 576 (10%) were readmitted to the ICU during the same hospitalization. Compared with nonreadmitted patients, patients readmitted to the ICU were more often men (349 of 576 patients [60.6%] vs. 2,919 of 5,203 patients [56.1%]; P = 0.042), showed a higher (median [interquartile range]) severity of illness (Simplified Acute Physiology III score) at index ICU admission (50 [41-61] vs. 42 [32-54], respectively, for readmitted and nonreadmitted patients; P < 0.001), and were more frequently admitted due to medical reasons (425 of 576 [73.8%] vs. 2,998 of 5,203 [57.6%], respectively, for readmitted and nonreadmitted patients; P < 0.001). Simplified Acute Physiology III score (P < 0.001), ICU admission from the ward (odds ratio [OR], 1.907; 95% confidence interval [CI], 1.463-2.487; P < 0.001), vasopressors need during index ICU stay (OR, 1.391; 95% CI, 1.130-1.713; P = 0.002), and length of ICU stay (P = 0.001) were independent predictors of ICU readmission. After adjusting for severity of illness, ICU readmission (OR, 4.103; 95% CI, 3.226-5.518; P < 0.001), admission source, presence of cancer, use of vasopressors, mechanical ventilation or renal replacement therapy, length of ICU stay, and nighttime ICU discharge were associated with increased risk of in-hospital death., Conclusions: Readmissions to the ICU were frequent and strongly related to poor outcomes. The degree to which ICU readmissions are preventable as well as the main causes of preventable ICU readmissions need to be further determined.