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Importance: Slower intravenous fluid infusion rates could reduce the formation of tissue edema and organ dysfunction in critically ill patients; however, there are no data to support different infusion rates during fluid challenges for important outcomes such as mortality.Objective: To determine the effect of a slower infusion rate vs control infusion rate on 90-day survival in patients in the intensive care unit (ICU).Design, Setting, and Participants: Unblinded randomized factorial clinical trial in 75 ICUs in Brazil, involving 11 052 patients requiring at least 1 fluid challenge and with 1 risk factor for worse outcomes were randomized from May 29, 2017, to March 2, 2020. Follow-up was concluded on October 29, 2020. Patients were randomized to 2 different infusion rates (reported in this article) and 2 different fluid types (balanced fluids or saline, reported separately).Interventions: Patients were randomized to receive fluid challenges at 2 different infusion rates; 5538 to the slower rate (333 mL/h) and 5514 to the control group (999 mL/h). Patients were also randomized to receive balanced solution or 0.9% saline using a factorial design.Main Outcomes and Measures: The primary end point was 90-day survival.Results: Of all randomized patients, 10 520 (95.2%) were analyzed (mean age, 61.1 years [SD, 17.0 years]; 44.2% were women) after excluding duplicates and consent withdrawals. Patients assigned to the slower rate received a mean of 1162 mL on the first day vs 1252 mL for the control group. By day 90, 1406 of 5276 patients (26.6%) in the slower rate group had died vs 1414 of 5244 (27.0%) in the control group (adjusted hazard ratio, 1.03; 95% CI, 0.96-1.11; P = .46). There was no significant interaction between fluid type and infusion rate (P = .98).Conclusions and Relevance: Among patients in the intensive care unit requiring fluid challenges, infusing at a slower rate compared with a faster rate did not reduce 90-day mortality. These findings do not support the use of a slower infusion rate.Trial Registration: ClinicalTrials.gov Identifier: NCT02875873. [ABSTRACT FROM AUTHOR]

Background: Very elderly critically ill patients (ie, those older than 75 or 80 years) are an increasing population in intensive care units. However, patients with cancer have encompassed only a minority in epidemiological studies of very old critically-ill patients. We aimed to describe clinical characteristics and identify factors associated with hospital mortality in a cohort of patients aged 80 or older with cancer admitted to intensive care units (ICUs). Methods: This was a retrospective cohort study in 94 ICUs in Brazil. We included patients aged 80 years or older with active cancer who had an unplanned admission. We performed a mixed effect logistic regression model to identify variables independently associated with hospital mortality. Results: Of 4604 included patients, 1807 (39.2%) died in hospital. Solid metastatic (OR = 2.46; CI 95%, 2.01–3.00), hematological cancer (OR = 2.32; CI 95%, 1.75–3.09), moderate/severe performance status impairment (OR = 1.59; CI 95%, 1.33–1.90) and use of vasopressors (OR = 4.74; CI 95%, 3.88–5.79), mechanical ventilation (OR = 1.54; CI 95%, 1.25–1.89) and renal replacement (OR = 1.81; CI 95%, 1.29–2.55) therapy were independently associated with increased hospital mortality. Emergency surgical admissions were associated with lower mortality compared to medical admissions (OR = 0.71; CI 95%, 0.52–0.96). Conclusions: Hospital mortality rate in very elderly critically ill patients with cancer with unplanned ICU admissions are lower than expected a priori. Cancer characteristics, performance status impairment and acute organ dysfunctions are associated with increased mortality. [ABSTRACT FROM AUTHOR]

Objective: To analyze the impact of gestational age (GA) at the time of fetal open spinal dysraphism (OSD) repair through a mini-hysterotomy on the perinatal outcomes and the infants' ventriculoperitoneal shunt rates.Methods: Retrospective study of cases of fetal OSD correction performed from 2014 and 2019.Results: One hundred and ninety women underwent fetal surgery for OSD through a mini-hysterotomy, and 176 (176/190:92.6%) have since delivered. Fetal OSD correction performed earlier in the gestational period, ranging from 19.7 to 26.9 weeks, was associated with lower rates of postnatal ventriculoperitoneal shunting (P: .049). Earlier fetal surgeries were associated with shorter surgical times (P: .01), smaller hysterotomy lengths (P < .001), higher frequencies of hindbrain herniation reversal (P: .003), and longer latencies from surgery to delivery (P < .001). Median GA at delivery was 35.3 weeks. Multivariate binary logistic regression showed that both fetal lateral ventricle-to-hemisphere ratio (%; P < .001; OR: 1.14 [95% CI: 1.09-1.21]) and GA at the time of fetal surgery (P: .016; OR: 1.37 [95% CI: 1.07-1.77]) were independent predictors of postnatal ventriculoperitoneal shunting.Conclusion: Fetuses with OSD who were operated on earlier in the gestational interval, which ranged from 19.7 to 26.9 weeks, were less prone to receiving postnatal ventriculoperitoneal shunts. [ABSTRACT FROM AUTHOR]

Importance: The effects of recruitment maneuvers and positive end-expiratory pressure (PEEP) titration on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remain uncertain.Objective: To determine if lung recruitment associated with PEEP titration according to the best respiratory-system compliance decreases 28-day mortality of patients with moderate to severe ARDS compared with a conventional low-PEEP strategy.Design, Setting, and Participants: Multicenter, randomized trial conducted at 120 intensive care units (ICUs) from 9 countries from November 17, 2011, through April 25, 2017, enrolling adults with moderate to severe ARDS.Interventions: An experimental strategy with a lung recruitment maneuver and PEEP titration according to the best respiratory-system compliance (n = 501; experimental group) or a control strategy of low PEEP (n = 509). All patients received volume-assist control mode until weaning.Main Outcomes and Measures: The primary outcome was all-cause mortality until 28 days. Secondary outcomes were length of ICU and hospital stay; ventilator-free days through day 28; pneumothorax requiring drainage within 7 days; barotrauma within 7 days; and ICU, in-hospital, and 6-month mortality.Results: A total of 1010 patients (37.5% female; mean [SD] age, 50.9 [17.4] years) were enrolled and followed up. At 28 days, 277 of 501 patients (55.3%) in the experimental group and 251 of 509 patients (49.3%) in the control group had died (hazard ratio [HR], 1.20; 95% CI, 1.01 to 1.42; P = .041). Compared with the control group, the experimental group strategy increased 6-month mortality (65.3% vs 59.9%; HR, 1.18; 95% CI, 1.01 to 1.38; P = .04), decreased the number of mean ventilator-free days (5.3 vs 6.4; difference, -1.1; 95% CI, -2.1 to -0.1; P = .03), increased the risk of pneumothorax requiring drainage (3.2% vs 1.2%; difference, 2.0%; 95% CI, 0.0% to 4.0%; P = .03), and the risk of barotrauma (5.6% vs 1.6%; difference, 4.0%; 95% CI, 1.5% to 6.5%; P = .001). There were no significant differences in the length of ICU stay, length of hospital stay, ICU mortality, and in-hospital mortality.Conclusions and Relevance: In patients with moderate to severe ARDS, a strategy with lung recruitment and titrated PEEP compared with low PEEP increased 28-day all-cause mortality. These findings do not support the routine use of lung recruitment maneuver and PEEP titration in these patients.Trial Registration: clinicaltrials.gov Identifier: NCT01374022. [ABSTRACT FROM AUTHOR]

Objective: To present the feasibility of fetal myelomeningocele (MMC) repair through a mini-hysterotomy and to describe the perinatal results from our initial experience.Methods: A descriptive study of cases of fetal MMC correction via mini-hysterotomy performed between 2014 and 2016.Results: Forty-five women underwent fetal surgery and 87% (39/45) delivered. A complete multilayer correction of the MMC was possible in all cases. There were no maternal, fetal or neonatal deaths. No maternal or fetal complications occurred from fetal MMC correction until maternal hospital discharge. The average gestational age (GA) at surgery was 24.5 weeks (standard deviation, SD: 1.7; range: 20.7-26.9). The median hysterotomy length was 3.05 cm (SD: 0.39; range: 2.50-3.50). One patient (1/39; 2.6%) experienced chorioamniotic separation. Nine patients (9/39; 23.1%) had premature preterm rupture of membranes at a median GA of 34.1 weeks (range: 31.1-36.0). The average GA at delivery was 35.3 weeks (SD: 2.2; range: 27.9-39.1). Ninety-five percent (37/39) of our patients had an intact hysterotomy site at delivery. Ventriculoperitoneal shunt placement was necessary for 7.7% (3/39) of the neonates.Conclusion: Fetal MMC repair is feasible through a mini-hysterotomy. This approach appears to be associated with reduced risks of very preterm delivery and maternal, fetal and neonatal complications. [ABSTRACT FROM AUTHOR]

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

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

Background: The recommendations in guidelines are based on evidence; however, there is a gap between recommendations and clinical practice., Objective: To describe the practice of prescribing evidence-based treatments for patients with acute coronary syndrome in Brazil., Methods: This study carried out a subanalysis of the ACCEPT registry, assessing epidemiological data and the prescription rate of acetylsalicylic acid, p2y12 inhibitors, antithrombotic drugs, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (IAT1RB), and statins. In addition, the quality of myocardial reperfusion in ST-segment elevation myocardial infarction was evaluated., Results: This study assessed 2,453 patients. The prescription rates of acetylsalicylic acid, p2y12 inhibitors, antithrombotic drugs, beta-blockers, angiotensin-converting enzyme inhibitors/IAT1RB, and statins were as follows: in 24 hours - 97.6%, 89.5%, 89.1%, 80.2%, 67.9% and 90.6%; and at six months - 89.3%, 53.6%, 0%, 74.4%, 57.6% and 85.4%, respectively. Regarding ST-segment elevation myocardial infarction, only 35.9% and 25.3% of the patients underwent primary angioplasty and thrombolysis, respectively, within the recommended times., Conclusion: This registry showed high initial prescription rates of antiplatelet drugs, antithrombotic drugs, and statins, and lower prescription rates of beta-blockers and angiotensin-converting enzyme inhibitors/IAT1RB. Independently of the class, the use of all drugs decreased by six months. Most patients with ST-segment elevation myocardial infarction did not undergo myocardial reperfusion within the time recommended.

Background: Available predictive models for acute coronary syndromes (ACS) have limitations as they have been elaborated some years ago or limitations with applicability., Objectives: To develop scores for predicting adverse events in 30 days and 6 months in ST-segment elevation and non-ST-segment elevation ACS patients admitted to private tertiary hospital., Methods: Prospective cohort of ACS patients admitted between August, 2009 and June, 2012. Our primary composite outcome for both the 30-day and 6-month models was death from any cause, myocardial infarction or re-infarction, cerebrovascular accident (CVA), cardiac arrest and major bleeding. Predicting variables were selected for clinical, laboratory, electrocardiographic and therapeutic data. The final model was obtained with multiple logistic regression and submitted to internal validation with bootstrap analysis., Results: We considered 760 patients for the development sample, of which 132 had ST-segment elevation ACS and 628 non-ST-segment elevation ACS. The mean age was 63.2 ± 11.7 years, and 583 were men (76.7%). The final model to predict 30-day events is comprised by five independent variables: age ≥ 70 years, history of cancer, left ventricular ejection fraction (LVEF) < 40%, troponin I > 12.4 ng /ml and chemical thrombolysis. In the internal validation, the model showed good discrimination with C-statistic of 0.71. The predictors in the 6-month event final model are: history of cancer, LVEF < 40%, chemical thrombolysis, troponin I >14.3 ng/ml, serum creatinine>1.2 mg/dl, history of chronic obstructive pulmonary disease and hemoglobin < 13.5 g/dl. In the internal validation, the model had good performance with C-statistic of 0.69., Conclusion: We have developed easy to apply scores for predicting 30-day and 6-month adverse events in patients with ST-elevation and non-ST-elevation ACS.

Background: There are few registries documenting clinical practice in Brazilian patients with acute coronary syndrome., Objectives: Demography description, occurrence of major clinical adverse events and comparative analysis in patients submitted or not to an invasive strategy (coronary angiography and myocardial revascularization) in a Brazilian multicenter registry of acute coronary syndrome., Methods: The ACCEPT/SBC registry prospectively collected data on acute coronary syndrome patients from 47 Brazilian hospitals. The current analysis reports the occurrence of major clinical outcomes and according to the performance or not of a procedure for myocardial revascularization at the end of 30 day follow-up., Results: Between August 2010 and December 2011, 2.485 patients were enrolled in this registry. Of these, 31.6% had unstable angina, 34.9% and 33.4% had acute coronary syndrome without and with ST-segment elevation. At 30 days, the performance of a myocardial revascularization procedure was progressively higher according to the severity of clinical presentation (38.7% vs. 53.6% vs. 77.7%, p < 0.001). Cardiac mortality among those submitted or not to myocardial revascularization procedure was 1.0% vs. 2.3% (p = 0.268), 1.9% vs. 4.2% (p = 0.070) and 2.0% vs. 8.1% (p < 0.001), in those with unstable angina, acute coronary syndrome without and with ST-segment elevation, respectively., Conclusions: The prescription of a myocardial revascularization procedure was progressively more frequent according to the severity of clinical presentation; for those treated during acute coronary syndrome without and with ST-segment elevation, there was a trend and significant decrease in mortality rate at 30 day of follow-up, respectively.

Background: Despite the increasing number of elderly people, this high-complexity subset of patients is often excluded from randomized trials of percutaneous coronary intervention (PCI) and, therefore, limited data are available about their outcomes after drug-eluting stent (DES) implantation. We sought to compare the very long-term (> 1 year) clinical follow up of octogenarians treated with DES compared to younger individuals., Methods: The DESIRE registry is a prospective, nonrandomized, single-center registry with consecutive patients treated solely with DES between May 2002 and May 2007. The only exclusion criteria were the treatment of patients in the setting of acute myocardial infarction (MI) (< 72 hours) and lesions located in non-native coronary arteries. The primary endpoint was the occurrence of combined major adverse cardiac events (MACE) (cardiac death, non-fatal MI and target vessel revascularization) in-hospital and in very long term (> 1 year) follow up. Patients were clinically evaluated at 1, 3 and 6 months and then annually up to 5 years. Stent thrombosis was classified according to the ARC definition., Results: A total of 1,364 patients matched the inclusion/exclusion criteria and were sorted into 3 groups according to their ages: Group I = patients < 70 years of age (n = 914); Group II = patients greater than or equal to 70 and < 80 years of age (n = 334); and Group III = patients greater than or equal to 80 years old (n = 116). As expected, octogenarians had significantly more comorbid and complex anatomic lesion presentation. Nevertheless, in-hospital success was comparable among the 3 groups. Long-term (2.6 +/- 1.2 years) follow up was obtained from 97% of the total population and showed equivalent cumulative MACE in all age ranges (7.6% for < 70 years old vs. 5.4% for septuagenarians and 6.0% for octogenarians, p = 0.7). However, octogenarians had markedly more cardiac death, reflecting the severity of their comorbidity and the natural evolution of coronary disease. Of note, very few cases of stent thrombosis were noticed in the overall population (20 patients, 1.5%), with no difference among the groups., Conclusions: PCI with DES represents an efficient and safe approach to treat coronary artery disease in the elderly, with low rates of combined MACE comparable to other age ranges.

Persistent cyanosis is a frequent complication in the post-operative period of Sano modification of the Norwood procedure. It may be explained by a dynamic proximal shunt stenosis of the synthetic conduit that links the right ventricle to the pulmonary artery, as detected by echo cardiographic study. The use of beta-blockers in the post-operative period has been recently described in order to improve the arterial oxygen saturation. In this report, we describe the use of propranolol in two patients undergoing Sano modification of the Norwood procedure, in whom a gradient reduction in the synthetic conduit, increase in the levels of arterial oxygen saturation, decrease in heart rate, and increase in blood pressure were observed, thus resulting in clinical improvement. We conclude that the use of beta-blockers in these cases was beneficial.

Objectives: To evaluate the safety and efficacy of percutaneous thrombus fragmentation (PTF) for massive pulmonary embolism (PE) in patients with contraindications to the administration of thrombolytics., Methods: Between July 1999 and August 2005, 10 patients (7 males, 3 females, age 57+/-18 years) with massive PE and contraindications to the administration of thrombolytics underwent PTF. A transthoracic doppler echocardiogram was used to evaluate arterial oxygen saturation (Sat O2), the Walsh index (WI), mean pulmonary artery pressure (PAP), mean systemic blood pressure (SBP) and right ventricular function (RVF) before and after the procedure. Statistical analysis was conducted using the paired Wilcoxon test, of which p was significant when < 0.05., Results: After the PTF treatment there was an improvement in Sat. O2 [87.4 +/- 1.3% vs 92.3 +/- 3.1% (p < 0.001)], WI [6.4 +/- 1.07 vs 4.4 +/- 1.42 (p = 0.003)], PAP [31.8 +/- 4.6 mmHg vs 25.5 +/- 3.4 mmHg (p < 0.001)] and SBP [73.9 +/- 8.7 vs 85 +/- 8.3 (p = 0.001). The ten patients had severe RVF before the percutaneous treatment; however, within 10 days after PTF, 8 presented normal or discrete function and 1 presented mitigated function. There were no technical or vascular access site complications related to PTF. One patient died in the hospital (10%). The procedure was successful for the other nine patients., Conclusion: The lack of adverse complications related to the procedure, proves that PTF is safe. The improvement in Sat O2, WI, PAP, SBP and RVF in 90% of the cases demonstrates the efficacy of the procedure, indicating that it is an alternative treatment for massive PE in patients with contraindications for the administration of systemic thrombolytics.

Objective: To identify risk factors for acute myocardial infarction during the postoperative period after myocardial revascularization., Methods: This was a case-control study paired for sex, age, number, type of graft used, coronary endarterectomy, type of myocardial protection, and use of extracorporeal circulation. We assessed 178 patients (89 patients in each group) undergoing myocardial revascularization, and the following variables were considered: dyslipidemia, systemic hypertension, smoking, diabetes mellitus, previous myocardial revascularization surgery, previous coronary angioplasty, and acute myocardial infarction., Results: Baseline clinical characteristics did not differ in the groups, except for previous myocardial revascularization surgery, prevalent in the case group (34 patients vs. 12 patients; p = 0.0002). This was the only independent predictor of risk for acute myocardial infarction in the postoperative period, based on a multivariate logistic regression analysis (p = 0.0001). Mortality and the time of hospital stay of the case group were significantly higher (19.1% vs. 1.1%; p < 0.001 and 15.7 days vs. 10.6 days; p < 0.05 respectively) than those of the control., Conclusion: Only previous myocardial revascularization was an independent predictor of acute myocardial infarction in the postoperative period, based on multivariate logistic regression analysis.