Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure <= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt

The Impact of Body Mass Index in Patients with Severe Burn Injury

This study evaluated the association of body mass index (BMI) with mortality, length of stay in the intensive care unit (ICU), and length of hospital stay in major burn patients. It was a retrospective cohort study that was originally conducted from January 2017 to January 2020 and that used data from patients admitted to the intensive care unit for burns at a university hospital. The patients were divided into groups for the purposes of comparing relevant variables according to their BMI. We evaluated 288 patients: 52.8% were classified as eutrophic, 33.7% were classified as overweight, and 13.5% were classified as obese. The median length of stay in the ICU was 11 days for all patients, 9 days for eutrophic patients, 13 days for overweight patients, and 16 days for obese patients (p = 0.004). In the multivariate analysis, age (HR = 1.026; p < 0.001), total body surface area (HR = 1.047; p < 0.001), and the presence of inhalation injury (HR = 1.658; p = 0.026) were associated with mortality. Obesity was not associated with higher hospital mortality in this sample of burn patients. The length of stay in the ICU was longer among obese patients. Age, burned body surface, and the presence of inhalation injury were the major determinants of death in these patients

Improved performance of an intensive care unit after changing the admission triage model

Abstract The aim of this study is to analyze the effect of implementing a prioritization triage model for admission to an intensive care unit on the outcome of critically ill patients. Retrospective longitudinal study of adult patients admitted to the Intensive Care Unit (ICU) carried out from January 2013 to December 2017. The primary outcome considered was vital status at hospital discharge. Patients were divided into period 1 (chronological triage) during the years 2013 and 2014 and period 2 (prioritization triage) during the years 2015–2017. A total of 1227 patients in period 1 and 2056 in period 2 were analyzed. Patients admitted in period 2 were older (59.8 years) compared to period 1 (57.3 years; p < 0.001) with less chronic diseases (13.6% vs. 19.2%; p = 0.001), and higher median APACHE II score (21.0 vs. 18.0; p < 0.001)) and TISS 28 score (28.0 vs. 27.0; p < 0.001). In period 2, patients tended to stay in the ICU for a shorter time (8.5 ± 11.8 days) compared to period 1 (9.6 ± 16.0 days; p = 0.060) and had lower mortality at ICU (32.8% vs. 36.9%; p = 0.016) and hospital discharge (44.2% vs. 47.8%; p = 0.041). The change in the triage model from a chronological model to a prioritization model resulted in improvement in the performance of the ICU and reduction in the hospital mortality rate

A prospective study of treatment of carbapenem-resistant Enterobacteriaceae infections and risk factors associated with outcome

Abstract Background To describe the clinical and microbiological data of carbapenem-resistant Enterobacteriaceae (CRE) infections, the treatment used, hospital- and infection-related mortality, and risk factors for death. Methods A prospective cohort conducted from March 2011 to December 2012. Clinical, demographic, and microbiological data such as in vitro sensitivity, clonality, carbapenemase gene mortality related to infection, and overall mortality were evaluated. Data were analyzed using Epi Info version 7.0 (CDC, Atlanta, GA, USA) and SPSS (Chicago, IL, USA). Results One hundred and twenty-seven patients were evaluated. Pneumonia, 52 (42 %), and urinary tract infections (UTI), 51 (40.2 %), were the most frequent sites of infection. The isolates were polyclonal; the Bla KPC gene was found in 75.6 % of isolates, and 27 % of isolates were resistant to colistin. Mortality related to infection was 34.6 %, and was higher among patients with pneumonia (61.4 %). Combination therapy was used in 98 (77.2 %), and monotherapy in 22.8 %; 96.5 % of them were UTI patients. Shock, age, and dialysis were independent risk factors for death. There was no difference in infection-related death comparing colistin-susceptible and colistin-resistant infections (p = 0.46); neither in survival rate comparing the use of combination therapy with two drugs or more than two drugs (p = 0.32). Conclusions CRE infection mortality was higher among patients with pneumonia. Infections caused by colistin-resistant isolates did not increase mortality. The use of more than two drugs on combination therapy did not show a protective effect on outcome. The isolates were polyclonal, and the bla KPC gene was the only carbapenemase found. Shock, dialysis, and age over 60 years were independent risk factors for death

Symptoms awareness, emergency medical service utilization and hospital transfer delay in myocardial infarction

Abstract Background The length of time between symptom onset and reperfusion therapy in patients with ST-segment elevation acute myocardial infarction (STEMI) is a key determinant of mortality. Information on this delay is scarce, particularly for developing countries. The objective of the study is to prospectively evaluate the individual components of reperfusion time (RT) in patients with STEMI treated at a University Hospital in 2012. Methods Medical records were reviewed to determine RT, its main (patient delay time [PDT] and system delay time [SDT]) and secondary components and hospital access variables. Cognitive responses were evaluated using a semi-structured questionnaire. Results A total of 50 patients with a mean age of 59 years (SD = 10.5) were included, 64% of whom were male. The median RT was 430 min, with an interquartile range of 315–750 min. Regarding the composition of RT in the sample, PDT corresponded to 18.9% and SDT to 81.1%. Emergency medical services were used in 23.5% of cases. Patients treated in intermediate care units showed a significant increase in SDT (p = 0.008). Regarding cognitive variables, PDT was approximately 40 min longer among those who answered “I didn’t think it was serious” (p = 0.024). Conclusions In a Brazilian tertiary public hospital, RT was higher than that recommended by international guidelines, mainly because of long SDT, which was negatively affected by time spent in intermediate care units. Emergency Medical Services underutilization was noted. A patient’s low perception of severity increased PDT

Effect of Intravenous Fluid Treatment with a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial

Importance: Intravenous fluids are used for almost all intensive care unit (ICU) patients. Clinical and laboratory studies have questioned whether specific fluid types result in improved outcomes, including mortality and acute kidney injury. Objective: To determine the effect of a balanced solution vs saline solution (0.9% sodium chloride) on 90-day survival in critically ill patients. Design, Setting, and Participants: Double-blind, factorial, randomized clinical trial conducted at 75 ICUs in Brazil. Patients who were admitted to the ICU with at least 1 risk factor for worse outcomes, who required at least 1 fluid expansion, and who were expected to remain in the ICU for more than 24 hours were randomized between May 29, 2017, and March 2, 2020; follow-up concluded on October 29, 2020. Patients were randomized to 2 different fluid types (a balanced solution vs saline solution reported in this article) and 2 different infusion rates (reported separately). Interventions: Patients were randomly assigned 1:1 to receive either a balanced solution (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids. Main Outcomes and Measures: The primary outcome was 90-day survival. Results: Among 11052 patients who were randomized, 10520 (95.2%) were available for the analysis (mean age, 61.1 [SD, 17] years; 44.2% were women). There was no significant interaction between the 2 interventions (fluid type and infusion speed; P =.98). Planned surgical admissions represented 48.4% of all patients. Of all the patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment. Patients in both groups received a median of 1.5 L of fluid during the first day after enrollment. By day 90, 1381 of 5230 patients (26.4%) assigned to a balanced solution died vs 1439 of 5290 patients (27.2%) assigned to saline solution (adjusted hazard ratio, 0.97 [95% CI, 0.90-1.05]; P =.47). There were no unexpected treatment-related severe adverse events in either group. Conclusion and Relevance: Among critically ill patients requiring fluid challenges, use of a balanced solution compared with 0.9% saline solution did not significantly reduce 90-day mortality. The findings do not support the use of this balanced solution. Trial Registration: ClinicalTrials.gov Identifier: NCT02875873

Association between Type of Fluid Received Prior to Enrollment, Type of Admission, and Effect of Balanced Crystalloid in Critically Ill Adults A Secondary Exploratory Analysis of the BaSICS Clinical Trial

Rationale: The effects of balanced crystalloid versus saline on clinical outcomes for ICU patients may be modified by the type of fluid that patients received for initial resuscitation and by the type of admission. Objectives: To assess whether the results of a randomized controlled trial could be affected by fluid use before enrollment and admission type. Methods: Secondary post hoc analysis of the BaSICS (Balanced Solution in Intensive Care Study) trial, which compared a balanced solution (Plasma-Lyte 148) with 0.9% saline in the ICU. Patients were categorized according to fluid use in the 24 hours before enrollment in four groups (balanced solutions only, 0.9% saline only, a mix of both, and no fluid before enrollment) and according to admission type (planned, unplanned with sepsis, and unplanned without sepsis). The association between 90-day mortality and the randomization group was assessed using a hierarchical logistic Bayesian model. Measurements and Main Results: A total of 10,520 patients were included. There was a low probability that the balanced solution was associated with improved 90-day mortality in the whole trial population (odds ratio [OR], 0.95; 89% credible interval [CrI], 0.66–10.51; probability of benefit, 0.58); however, probability of benefit was high for patients who received only balanced solutions before enrollment (regardless of admission type, OR, 0.78; 89% CrI, 0.56–1.03; probability of benefit, 0.92), mostly because of a benefit in unplanned admissions due to sepsis (OR, 0.70; 89% CrI, 0.50–0.97; probability of benefit, 0.96) and planned admissions (OR, 0.79; 89% CrI, 0.65–0.97; probability of benefit, 0.97). Conclusions: There is a high probability that balanced solution use in the ICU reduces 90-day mortality in patients who exclusively received balanced fluids before trial enrollment. Clinical trial registered with www.clinicaltrials.gov (NCT 02875873)