; for the COALITION COVID-19 Brazil III Investigators 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.
Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine.
Objectives: To evaluate whether the use of exogenous melatonin affects sleep, reduces the prevalence of delirium, and decreases the need for analgosedation and to assess whether serum melatonin indices correlate with exogenous administration in critically ill patients. Design: Double-blind, randomized, placebo-controlled study. Setting: Multicenter ICUs of two tertiary hospitals. Patients: A total of 203 adult patients who were admitted to the ICU and administered with analgesics and/or sedatives. Interventions: Oral melatonin (10 mg) or placebo for up to seven consecutive nights. Measurements and Main Results: The number of observed sleeping hours at night was assessed by the bedside nurse. Sleep quality was evaluated using the Richards Campbell Questionnaire Sleep (RCSQ). The prevalence of delirium, pain, anxiety, adverse reactions, duration of mechanical ventilation, length of ICU and hospital stays, and doses of sedative and analgesic drugs administered were recorded. The use of analgesics and sedatives was assessed daily. Melatonin levels were determined by enzyme-linked immunosorbent assay. Based on the RCSQ results, sleep quality was assessed to be better in the melatonin group than that in the placebo group with a mean (sd) of 69.7 (21.2) and 60.7 (26.3), respectively (p = 0.029). About 45.8% and 34.4% of participants in the melatonin and placebo groups had very good sleep (risk ratio, 1.33; 95% CI, 0.94–1.89), whereas 3.1% and 14.6% had very poor sleep (risk ratio, 0.21; 95% CI, 0.06–0.71), respectively. No significant difference was observed regarding the days free of analgesics or sedatives, the duration of night sleep, and the occurrence of delirium, pain, and anxiety. Melatonin serum peak levels at 2 am were 150 pg/mL (range, 125–2,125 pg/mL) in the melatonin group and 32.5 pg/mL (range, 18.5–35 pg/mL) in the placebo group (p < 0.001). Conclusions: Melatonin was associated with better sleep quality, which suggests its possible role in the routine care of critically ill patients in the future.
IntroductionIn some studies including small populations of patients undergoing specific surgery, an intraoperative liberal infusion of fluids was associated with increasing morbidity when compared to restrictive strategies. Therefore, to evaluate the role of excessive fluid infusion in a general population with high-risk surgery is very important. The aim of this study was to evaluate the impact of intraoperative fluid balance on the postoperative organ dysfunction, infection and mortality rate.MethodsWe conducted a prospective cohort study during one year in four ICUs from three tertiary hospitals, which included patients aged 18 years or more who required postoperative ICU after undergoing major surgery. Patients who underwent palliative surgery and whose fluid balance could change in outcome were excluded. The calculation of fluid balance was based on preoperative fasting, insensible losses from surgeries and urine output minus fluid replacement intraoperatively.ResultsThe study included 479 patients. Mean age was 61.2 ± 17.0 years and 8.8% of patients died at the hospital during the study. The median duration of surgery was 4.0 (3.2 to 5.5) h and the value of the Simplified Acute Physiology Score (SAPS) 3 score was 41.8 ± 14.5. Comparing survivors and non-survivors, the intraoperative fluid balance from non-survivors was higher (1,950 (1,400 to 3,400) mL vs. 1,400 (1,000 to 1,600) mL, P <0.001). Patients with fluid balance above 2,000 mL intraoperatively had a longer ICU stay (4.0 (3.0 to 8.0) vs. 3.0 (2.0 to 6.0), P <0.001) and higher incidence of infectious (41.9% vs. 25.9%, P = 0.001), neurological (46.2% vs. 13.2%, P <0.001), cardiovascular (63.2% vs. 39.6%, P <0.001) and respiratory complications (34.3% vs. 11.6%, P <0.001). In multivariate analysis, the fluid balance was an independent factor for death (OR per 100 mL = 1.024; P = 0.006; 95% CI 1.007 to 1.041).ConclusionsPatients with excessive intraoperative fluid balance have more ICU complications and higher hospital mortality.
for the BaSICS investigators and the BRICNet members 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 MEASURESThe primary outcome was 90-day survival. RESULTS Among 11 052 patients who were randomized, 10 520 (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.
BACKGROUNDThe aim of this study was to determine the occurrence rate, demographics, clinical characteristics, and outcomes of patients with severe sepsis admitted to the emergency department.METHODSA prospective study evaluating all patients admitted to the emergency department unit in a public hospital of tertiary complexity in a six-month period was conducted. During this period, the emergency team was trained to diagnose sepsis. Patients who met the diagnostic criteria for severe sepsis were followed until their discharge from the hospital.RESULTSA total of 5,332 patients were admitted to the emergency department, and 342 met the criteria for severe sepsis/septic shock. The median (interquartile range) age of patients was 74 (65–84) years, and 52.1% were male. The median APACHE II and SOFA scores at diagnosis were 19 (15–25) and 5 (3–7), respectively. The median number of dysfunctional organ systems per patient was 2 (1–3). The median hospital length of stay was 10 (4.7–17) days, and the hospital mortality rate was 64%. Only 31% of the patients were diagnosed by the emergency department team as septic. About 33.5% of the 342 severe sepsis patients admitted to the emergency department were referred to an ICU, with a median time delay of 24 (12–48) hours. Training improved diagnosis and decreased the time delay for septic patients in arriving at the ICU.CONCLUSIONSThe occurrence rate of severe sepsis in the emergency department was 6.4%, and the rate of sepsis diagnosed by the emergency department team as well as the number of patients transferred to the ICU was very low. Educational campaigns are important to improve diagnosis and, hence, treatment of severe sepsis.
objectIve. The aim of this study was to evaluate the criteria used in clinical practice to triage patients who are candidates for ICU admission. Methods. This was a prospective cohort study conducted at a tertiary hospital. Patients were assessed for their need for ICU admission and ranked by priority into groups 1, 2, 3 and 4 (highest priority 1, lowest priority 4) and these groups were compared. results. The sample comprised 359 patients with a median age of 66 years (53.2-75.0). Median APACHE II score was 23 (18-30). The ICU granted 70.4% of requests for ICU beds. Patients who were refused admission to the ICU were older, 66.2±16.1 vs. 61.9±15.2 years (p= 0.02), and fewer priority 1 patients were refused ICU beds; 23.8% vs. 39.1% of requests refused (p=0.01). The opposite was observed with priorities 3 and 4. Priority 3 and 4 patients were older, scored higher on the prognostic scale and the organ dysfunction scale and had a higher bed refusal rate. Patients in priority groups 3 and 4 had higher in-ICU mortality rates when compared to priority 1 and 2 patients: 86.7% vs. 31.3% (p<0.001). conclusIon. Age, prognostic scores and organ dysfunction scores were all greater among priority 3 and 4 patients and were related to refusal of ICU admission. Patients refused admission to the ICU had higher mortality rates and mortality remained higher among priority 3 and 4 patients even when they were admitted to the ICU.
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