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Central nervous system (CNS) malignant neoplasms may lead to venous thromboembolism (VTE) and bleeding, which result in rehospitalization, morbidity and mortality. We aimed to assess the incidence of VTE and bleeding in this population. Methods: This systematic review and meta-analysis (PROSPERO CRD42023423949) were based on a standardized search of PubMed, Virtual Health Library and Cochrane (n = 1653) in July 2023. After duplicate removal, data screening and collection were conducted by independent reviewers. The combined rates and 95% confidence intervals for the incidence of VTE and bleeding were calculated using the random effects model with double arcsine transformation. Subgroup analyses were performed based on sex, age, income, and type of tumor. Heterogeneity was calculated using Cochran’s Q test and I 2 statistics. Egger’s test and funnel graphs were used to assess publication bias. Results: Only 36 studies were included, mainly retrospective cohorts (n = 30, 83.3%) from North America (n = 20). Most studies included were published in high-income countries. The sample size of studies varied between 34 and 21,384 adult patients, mostly based on gliomas (n = 30,045). For overall malignant primary CNS neoplasm, the pooled incidence was 13.68% (95%CI 9.79; 18.79) and 11.60% (95%CI 6.16; 18.41) for VTE and bleeding, respectively. The subgroup with elderly people aged 60 or over had the highest incidence of VTE (32.27% - 95%CI 14.40;53.31). The studies presented few biases, being mostly high quality. Despite some variability among the studies, we observed consistent results by performing sensitivity analysis, which highlight the robustness of our findings. Conclusions: Our study showed variability in the pooled incidence for both overall events and subgroup analyses. It was highlighted that individuals over 60 years old or diagnosed with GBM had a higher pooled incidence of VTE among those with overall CNS malignancies. It is important to note that the results of this meta-analysis refer mainly to studies carried out in high-income countries. This highlights the need for additional research in Latin America, and low- and middle-income countries.

Early termination of clinical trials due to low recruitment represents an understudied challenge for clinical research. We aimed to describe characteristics of cardiovascular trials terminated because of low recruitment and identify the major predictors of such early termination. We reviewed all cardiovascular clinical trials (7,042 studies) registered in ClinicalTrials.gov from February 29, 2000, to January 17, 2013, and assessed information about trials that were completed and those that were terminated early. Logistic regression models were developed to identify independent predictors of early termination due to low recruitment. Our search strategy identified 6,279 cardiovascular clinical trials, of which 684 (10.9%) were terminated prematurely. Of these halted trials, the main reason for termination was lower than expected recruitment (278 trials; 53.6%). When comparing trials that terminated early because of low recruitment with those that were completed, we found that studies funded by the National Institutes of Health or other US federal agencies (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.14-0.89), studies of behavior/diet intervention (OR 0.35, 95% CI 0.19-0.65), and single-arm design studies (OR 0.57, 95% CI 0.42-0.78) were associated with a lower risk of early termination. University/hospital-funded (OR 1.52, 95% CI 1.10-2.10) and mixed-source–funded studies (OR 2.14, 95% CI 1.52-3.01) were associated with a higher likelihood of early termination due to lower than expected recruitment rates. Low recruitment represents the main cause of early termination of cardiovascular clinical trials. Funding source, type of intervention, and study design are factors associated with early termination due to low recruitment and might be good targets for improving enrollment into cardiovascular clinical trials.

To analyze the profile and outcomes of patients who underwent valve heart surgery in Brazil, using information retrieved from the Brazilian Registry of Cardiovascular Surgeries in Adults (BYPASS Registry) database. This is a multicenter cohort study, evaluating 920 patients submitted to heart valve surgery. Demographics and postoperative clinical outcomes were assessed and compared to estimate mortality risk using the European System for Cardiac Operative Risk Evaluation (EuroSCORE). Isolated aortic valve replacement was the most frequently performed surgery (34%), followed by isolated mitral valve replacement (24.9%). Valve repair was performed in 21% of mitral procedures. Minimally invasive access was performed in 1.6% and the most frequent postoperative complications were arrhythmias (22.6%), infections (5.7%), and low-output syndrome (5.1%). Operations covered by the public health system accounted for 80.8% and the hospital mortality rate was 7.3%. The most frequent isolated valve surgery in Brazil is the aortic valve replacement by conventional open access and the rheumatic disease is still the main etiology for valve surgery. The BYPASS Registry has a fundamental role to provide information on the profile of patients with valve heart disease in our country in order to delineate adequate strategies for health promotion and resource allocation for cardiac surgery.

PurposeNew-onset atrial fibrillation (NOAF) is common and associated with increased morbidity and mortality. However, its clinical importance and management in critically ill patients are not well described. The aim of this scoping review is to assess the epidemiology and management strategies of NOAF during critical illness.MethodThe review was conducted in accordance with the PRISMA extension for scoping reviews. We searched PubMed, EMBASE and the Cochrane Library for studies assessing the incidence, outcome and management strategies of NOAF in adult critically ill patients. The quality of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.ResultsA total of 99 studies were included, of which 79 were observational and 20 were interventional. The incidence of NOAF varied from 1.7% to 43.9% with considerable inter-population variation (very low quality of evidence). Commonly identified risk factors for NOAF included higher age, cardiovascular comorbidities and sepsis. The occurrence of NOAF was associated with adverse outcomes, including stroke, prolonged length of stay and mortality (very low quality of evidence). We found limited data on the optimal management strategy with no evidence for firm benefit or harm for any intervention (very low/low quality of evidence).ConclusionsThe definition and incidence of NOAF in critically ill patients varied considerably and many risk factors were identified. NOAF seemed to be associated with adverse outcomes, but data were very limited and current management strategies are not evidence-based.

Background Optimal timing for the start of vasopressors (VP) in septic shock has not been widely studied since it is assumed that fluids must be administered in advance. We sought to evaluate whether a very early start of VP, even without completing the initial fluid loading, might impact clinical outcomes in septic shock. Methods A total of 337 patients with sepsis requiring VP support for at least 6 h were initially selected from a prospectively collected database in a 90-bed mixed-ICU during a 24-month period. They were classified into very-early (VE-VPs) or delayed vasopressor start (D-VPs) categories according to whether norepinephrine was initiated or not within/before the next hour of the first resuscitative fluid load. Then, VE-VPs ( n  = 93) patients were 1:1 propensity matched to D-VPs ( n  = 93) based on age; source of admission (emergency room, general wards, intensive care unit); chronic and acute comorbidities; and lactate, heart rate, systolic, and diastolic pressure at vasopressor start. A risk-adjusted Cox proportional hazard model was fitted to assess the association between VE-VPs and day 28 mortality. Finally, a sensitivity analysis was performed also including those patients requiring VP support for less than 6 h. Results Patients subjected to VE-VPs received significantly less resuscitation fluids at vasopressor starting (0[0–510] vs. 1500[650–2300] mL, p  < 0.001) and during the first 8 h of resuscitation (1100[500–1900] vs. 2600[1600–3800] mL, p  < 0.001), with no significant increase in acute renal failure and/or renal replacement therapy requirements. VE-VPs was related with significant lower net fluid balances 8 and 24 h after VPs. VE-VPs was also associated with a significant reduction in the risk of death compared to D-VPs (HR 0.31, CI95% 0.17–0.57, p  < 0.001) at day 28. Such association was maintained after including patients receiving vasopressors for < 6 h. Conclusion A very early start of vasopressor support seems to be safe, might limit the amount of fluids to resuscitate septic shock, and could lead to better clinical outcomes.

In 2007, the Saline versus Albumin Fluid Evaluation-Translation of Research Into Practice Study (SAFE-TRIPS) reported that 0.9% sodium chloride (saline) and hydroxyethyl starch (HES) were the most commonly used resuscitation fluids in intensive care unit (ICU) patients. Evidence has emerged since 2007 that these fluids are associated with adverse patient-centred outcomes. Based on the published evidence since 2007, we sought to determine the current type of fluid resuscitation used in clinical practice and the predictors of fluid choice and determine whether these have changed between 2007 and 2014. In 2014, an international, cross-sectional study was conducted (Fluid-TRIPS) to document current patterns of intravenous resuscitation fluid use and determine factors associated with fluid choice. We examined univariate and multivariate associations between patients and prescriber characteristics, geographical region and fluid type. Additionally, we report secular trends of resuscitation fluid use in a cohort of ICUs that participated in both the 2007 and 2014 studies. Regression analysis were conducted to determine changes in the administration of crystalloid or colloid between 2007 and 2014. In 2014, a total of 426 ICUs in 27 countries participated. Over the 24 hour study day, 1456/6707 (21.7%) patients received resuscitation fluid during 2716 resuscitation episodes. Crystalloids were administered to 1227/1456 (84.3%) patients during 2208/2716 (81.3%) episodes and colloids to 394/1456 (27.1%) patients during 581/2716 (21.4%) episodes. In multivariate analyses, practice significantly varied between geographical regions. Additionally, patients with a traumatic brain injury were less likely to receive colloid when compared to patients with no trauma (adjusted OR 0.24; 95% CI 0.1 to 0.62; p = 0.003). Patients in the ICU for one or more days where more likely to receive colloid compared to patients in the ICU on their admission date (adjusted OR 1.75; 95% CI 1.27 to 2.41; p = <0.001). For secular trends in fluid resuscitation, 84 ICUs in 17 countries contributed data. In 2007, 527/1663 (31.7%) patients received fluid resuscitation during 1167 episodes compared to 491/1763 (27.9%) patients during 960 episodes in 2014. The use of crystalloids increased from 498/1167 (42.7%) in 2007 to 694/960 (72.3%) in 2014 (odds ratio (OR) 3.75, 95% confidence interval (CI) 2.95 to 4.77; p = <0.001), primarily due to a significant increase in the use of buffered salt solutions. The use of colloids decreased from 724/1167 (62.0%) in 2007 to 297/960 (30.9%) in 2014 (OR 0.29, 95% CI 0.19 to 0.43; p = <0.001), primarily due to a decrease in the use of HES, but an overall increase in the use of albumin. Clinical practices of intravenous fluid resuscitation have changed between 2007 and 2014. Geographical location remains a strong predictor of the type of fluid administered for fluid resuscitation. Overall, there is a preferential use of crystalloids, specifically buffered salt solutions, over colloids. There is now an imperative to conduct a trial determining the safety and efficacy of these fluids on patient-centred outcomes. Clinicaltrials.gov: Fluid-Translation of research into practice study (Fluid-TRIPS) NCT02002013.

Background Early identification of patients with acute hypoxemic respiratory failure (AHRF) who are at risk of failing high-flow nasal cannula (HFNC) therapy could facilitate closer monitoring, and timely adjustment/escalation of treatment. We aimed to establish whether machine learning (ML) models could predict HFNC outcome, early in the course of treatment, with greater accuracy than currently used clinical indices. Methods We developed ML models trained using measurements made within the first 2 h of treatment from 184 AHRF patients (37% HFNC failures) treated at the respiratory ICU of the University Hospital of Modena between 2018 and 2023. For external validation, we used a dataset on 567 AHRF patients (22% failures) comprising 510 patients from the recent RENOVATE trial in Brazil and 57 from the MIMIC-IV and eICU databases in the US. Predictive performance of the ML models was benchmarked against optimized thresholds of the following clinical indices: respiratory rate oxygenation index (ROX) and variants, heart rate to saturation of pulse oxygen (SpO 2 ) ratio, SpO 2 /FiO 2 ratio, PaO 2 /FiO 2 ratio, sequential organ failure assessment and heart rate, acidosis, consciousness, oxygenation and respiratory rate scores. Results Internal and external predictive performance of a Support Vector Machine (SVM) ML model was superior to all clinical indices across all scenarios tested. In external validation on the 567-patient dataset, a SVM model trained on non-invasive measurements had an accuracy of 73%, sensitivity of 73%, specificity of 73%, and AUC of 0.79. The ROX index had an accuracy of 64%, sensitivity of 79%, specificity of 60%, and AUC of 0.74. When arterial blood gasses (ABG’s) were also used for model training, the SVM model had an accuracy of 83%, sensitivity of 84%, specificity of 82%, and AUC of 0.82 in external validation on the MIMIC-IV/eICU dataset. The modified ROX index, which requires PaO 2 , achieved 70% accuracy, 63% sensitivity, 74% specificity, and AUC of 0.65. Conclusions Decision support tools based on SVM models could provide clinicians with more accurate early predictions of HFNC outcome than currently available clinical indices. If available, ABG measurements could improve the capability to accurately identify patients at risk of failing HFNC therapy.

Background Although light sedation levels are associated with several beneficial outcomes for critically ill patients on mechanical ventilation, the majority of patients are still deeply sedated. Organizational factors may play a role on adherence to light sedation levels. We aimed to identify organizational factors associated with a moderate to light sedation target on the first 48 h of mechanical ventilation, as well as the association between early achievement of within-target sedation and mortality. Methods This study is a secondary analysis of a multicenter two-phase study (prospective cohort followed by a cluster-randomized controlled trial) performed in 118 Brazilian ICUs. We included all critically ill patients who were on mechanical ventilation 48 h after ICU admission. A moderate to light level of sedation or being alert and calm (i.e., the Richmond Agitation-Sedation Scale of − 3 to 0) was the target for all patients on mechanical ventilation during the study period. We collected data on the type of hospital (public, private, profit and private, nonprofit), hospital teaching status, nursing and physician staffing, and presence of sedation, analgesia, and weaning protocols. We used multivariate random-effects regression with ICU and study phase as random-effects and correction for patients’ Simplified Acute Physiology Score 3 and Sequential Organ Failure Assessment. We also performed a mediation analysis to explore whether sedation level was just a mediator of the association between organizational factors and mortality. Results We included 5719 patients. Only 1710 (29.9%) were on target sedation levels on day 2. Board-certified intensivists on the morning and afternoon shifts were associated with an adequate sedation level on day 2 (OR = 2.43; CI 95%, 1.09–5.38). Target sedation levels were associated with reduced hospital mortality (OR = 0.63; CI 95%, 0.55–0.72). Mediation analysis also suggested such an association, but did not suggest a relationship between the physician staffing model and hospital mortality. Conclusions Board-certified intensivists on morning and afternoon shifts were associated with an increased number of patients achieving lighter sedation goals. These findings reinforce the importance of organizational factors, such as intensivists’ presence, as a modifiable quality improvement target.

[...]the figures we provided, 290 (95% CI 237·9-351·2) cases of ICU-treated sepsis per 100 000 adult population with approximately 420 000 cases of sepsis per year in Brazil, are intended to be considered as rough estimates of the sepsis incidence in the country. [...]future cohort studies are needed to better estimate sepsis incidence.