Explore the vast range of titles available.

In a randomized trial, over 4500 patients undergoing cardiac surgery were assigned to receive tranexamic acid or placebo. There was no difference between groups in the rate of death or thrombotic complications. The tranexamic acid group had less bleeding and more seizures. Excessive bleeding and blood transfusions are common in patients undergoing cardiac surgery, 1 and in some of these patients, there is a need for reoperation because of life-threatening bleeding. 2 Both blood transfusion and reoperation are strongly associated with poor outcomes after cardiac surgery. 2 , 3 Antifibrinolytic therapy reduces the risk of blood loss and transfusion among patients undergoing cardiac surgery, 4 , 5 but it is unclear whether such therapy reduces the risk of reoperation for bleeding. 4 Antifibrinolytic agents that have been used in patients undergoing cardiac surgery include aprotinin 6 , 7 and the lysine analogues tranexamic acid and aminocaproic acid. 8 – 11 These agents may . . .

In a large, blinded, randomized trial involving critically ill adults, no significant difference in 90-day mortality was noted between those who received red cells stored for a mean of 11.8 days and those who received red cells stored for a mean of 22.4 days.

Patients with severe traumatic brain injury and refractory intracranial hypertension were randomly assigned to either decompressive craniectomy or standard care. Craniectomy was associated with a significant reduction in intracranial pressure but worse outcomes. Among patients who are hospitalized with severe traumatic brain injury, 60% either die or survive with severe disability. 1 – 3 Of Australia's population of 22 million, 4 approximately 1000 patients annually sustain a severe traumatic brain injury, with associated lifetime costs estimated at $1 billion. 5 In the United States, the annual burden of traumatic brain injury is more than $60 billion. 6 After severe traumatic brain injury, medical and surgical therapies are performed to minimize secondary brain injury. 7 – 9 Increased intracranial pressure, which is typically caused by cerebral edema, is an important secondary insult. 7 , 9 , 10 Although few data regarding the monitoring of . . .

Background There are few reports of new functional impairment following critical illness from COVID-19. We aimed to describe the incidence of death or new disability, functional impairment and changes in health-related quality of life of patients after COVID-19 critical illness at 6 months. Methods In a nationally representative, multicenter, prospective cohort study of COVID-19 critical illness, we determined the prevalence of death or new disability at 6 months, the primary outcome. We measured mortality, new disability and return to work with changes in the World Health Organization Disability Assessment Schedule 2.0 12L (WHODAS) and health status with the EQ5D-5L TM . Results Of 274 eligible patients, 212 were enrolled from 30 hospitals. The median age was 61 (51–70) years, and 124 (58.5%) patients were male. At 6 months, 43/160 (26.9%) patients died and 42/108 (38.9%) responding survivors reported new disability. Compared to pre-illness, the WHODAS percentage score worsened (mean difference (MD), 10.40% [95% CI 7.06–13.77]; p  < 0.001). Thirteen (11.4%) survivors had not returned to work due to poor health. There was a decrease in the EQ-5D-5L TM utility score (MD, − 0.19 [− 0.28 to − 0.10]; p  < 0.001). At 6 months, 82 of 115 (71.3%) patients reported persistent symptoms. The independent predictors of death or new disability were higher severity of illness and increased frailty. Conclusions At six months after COVID-19 critical illness, death and new disability was substantial. Over a third of survivors had new disability, which was widespread across all areas of functioning. Clinical trial registration NCT04401254 May 26, 2020.

Erythropoietin might have neurocytoprotective effects. In this trial, we studied its effect on neurological recovery, mortality, and venous thrombotic events in patients with traumatic brain injury. Erythropoietin in Traumatic Brain Injury (EPO-TBI) was a double-blind, placebo-controlled trial undertaken in 29 centres (all university-affiliated teaching hospitals) in seven countries (Australia, New Zealand, France, Germany, Finland, Ireland, and Saudi Arabia). Within 24 h of brain injury, 606 patients were randomly assigned by a concealed web-based computer-generated randomisation schedule to erythropoietin (40 000 units subcutaneously) or placebo (0·9% sodium chloride subcutaneously) once per week for a maximum of three doses. Randomisation was stratified by severity of traumatic brain injury (moderate vs severe) and participating site. With the exception of designated site pharmacists, the site dosing nurses at all sites, and the pharmacists at the central pharmacy in France, all study personnel, patients, and patients' relatives were masked to treatment assignment. The primary outcome, assessed at 6 months by modified intention-to-treat analysis, was improvement in the patients' neurological status, summarised as a reduction in the proportion of patients with an Extended Glasgow Outcome Scale (GOS-E) of 1–4 (death, vegetative state, and severe disability). Two equally spaced preplanned interim analyses were done (after 202 and 404 participants were enrolled). This study is registered with ClinicalTrials.gov, number NCT00987454. Between May 3, 2010, and Nov 1, 2014, 606 patients were enrolled and randomly assigned to erythropoietin (n=308) or placebo (n=298). Ten of these patients (six in the erythropoietin group and four in the placebo group) were lost to follow up at 6 months; therefore, data for the primary outcome analysis was available for 596 patients (302 in the erythropoietin group and 294 in the placebo group). Compared with placebo, erythropoietin did not reduce the proportion of patients with a GOS-E level of 1–4 (134 [44%] of 302 patients in the erythropoietin group vs 132 [45%] of 294 in the placebo group; relative risk [RR] 0·99 [95% CI 0·83–1·18], p=0·90). In terms of safety, erythropoietin did not significantly affect 6-month mortality versus placebo (32 [11%] of 305 patients had died at 6 months in the erythropoietin group vs 46 [16%] of 297 [16%] in the placebo group; RR 0·68 [95% CI 0·44–1·03], p=0·07) or increase the occurrence of deep venous thrombosis of the lower limbs (48 [16%] of 305 vs 54 [18%] of 298; RR 0·87 [95% CI 0·61–1·24], p=0·44). Following moderate or severe traumatic brain injury, erythropoietin did not reduce the number of patients with severe neurological dysfunction (GOS-E level 1–4) or increase the incidence of deep venous thrombosis of the lower limbs. The effect of erythropoietin on mortality remains uncertain. The National Health and Medical Research Council and the Transport Accident Commission.

Objective To compare the effects of vasopressin versus norepinephrine infusion on the outcome of kidney injury in septic shock. Design and setting Post-hoc analysis of the multi-center double-blind randomized controlled trial of vasopressin versus norepinephrine in adult patients who had septic shock (VASST). Patients and intervention Seven hundred seventy-eight patients were randomized to receive a blinded infusion of either low-dose vasopressin (0.01–0.03 U/min) or norepinephrine infusion (5–15 μg/min) in addition to open-label vasopressors and were included in the outcome analysis. All vasopressors were titrated and weaned to maintain a target blood pressure. Measurement and results RIFLE criteria for acute kidney injury were used to compare the effects of vasopressin versus norepinephrine. In view of multiple simultaneous comparisons, a p value of 0.01 was considered statistically significant. Kidney injury was present in 464 patients (59.6%) at study entry. In patients in the RIFLE “Risk” category ( n  = 106), vasopressin as compared with norepinephrine was associated with a trend to a lower rate of progression to renal “Failure” or “Loss” categories (20.8 vs. 39.6%, respectively, p  = 0.03), and a lower rate of use of renal replacement therapy (17.0 vs. 37.7%, p  = 0.02). Mortality rates in the “Risk” category patients treated with vasopressin compared to norepinephrine were 30.8 versus 54.7%, p  = 0.01, but this did not reach significance in a multiple logistic regression analysis (OR = 0.33, 99% CI 0.10–1.09, p  = 0.02). The interaction of treatment group and RIFLE category was significant in predicting mortality. Conclusions Vasopressin may reduce progression to renal failure and mortality in patients at risk of kidney injury who have septic shock.

In a randomized trial involving 2100 patients undergoing coronary artery surgery, the risk of bleeding within 30 days after surgery was not higher with aspirin than with placebo, nor was the risk of death or thrombosis within 30 days after surgery lower with aspirin than with placebo. Most patients with coronary artery disease take aspirin for primary or secondary prevention of thrombotic events. 1 Aspirin inhibits platelet function and therefore poses an increased risk of bleeding among patients undergoing coronary artery bypass grafting (CABG), 1 although this risk appears to be small. 2 – 5 Until recently, it has been traditional practice in most cardiac surgical centers to have patients stop taking aspirin 5 to 7 days before surgery to reduce the risk of bleeding. However, the increased risk of surgical bleeding could be outweighed by the beneficial effect of aspirin on coronary-graft flow and on reduction in the risk of . . .

IntroductionEffect size and event rate estimation is necessary for sample size calculation in randomised clinical trials. Overestimation of the effect size and event rate can lead to inadequately powered studies and increased probability of false negative results. This is common in trials involving critically ill patients. However, such overestimation has not been systematically evaluated in trials involving neurocritical care. We aimed to conduct a systematic review of published randomised clinical trials involving critically ill neurological patients, to determine the accuracy of effect size and event rate estimation.Methods and analysisWe will review randomised clinical trials involving adult critically ill neurological patients that were published from 2015 onwards in selected clinically useful and high-impact journals. We will include randomised clinical trials reporting a binary or time to event outcome, using two study groups, and a superiority design testing the efficacy of diagnostic, monitoring, therapeutic or process interventions. All eligible studies must report an estimated event rate in the control group and estimated effect size. All relevant studies will be identified through database searches. All study selection and data extraction will be conducted by two independent reviewers. We will use a random-effects model for pooling data. This review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. Accuracy of effect size and event rate estimation will be evaluated by comparing the estimated and observed values. The association between the accuracy of the individual randomised clinical trial effect size and event rate estimation and rejection of the null hypothesis will be evaluated using logistic regression analysis. Multivariable linear regression analysis will be used to explore the factors associated with accuracy of effect size and event rate estimation. In addition, we will perform subgroup analysis by impact factor of the published journals, sample size of the studies and risk of bias.Ethics and disseminationAs this systematic review will use data from previously published studies, it does not require ethics approval. Findings of this systematic review will be published in a peer-reviewed journal and will be presented at specialty-based conferences. The study will be included in the higher degree research thesis of the primary author.PROSPERO registration numberCRD420251106394.

Background Data on long-term outcomes after sepsis-associated critical illness have mostly come from small cohort studies, with no information about the incidence of new disability. We investigated whether sepsis-associated critical illness was independently associated with new disability at 6 months after ICU admission compared with other types of critical illness. Methods We conducted a secondary analysis of a multicenter, prospective cohort study in six metropolitan intensive care units in Australia. Adult patients were eligible if they had been admitted to the ICU and received more than 24 h of mechanical ventilation. There was no intervention. Results The primary outcome was new disability measured with the WHO Disability Assessment Schedule 2.0 (WHODAS) 12 level score compared between baseline and 6 months. Between enrollment and follow-up at 6 months, 222/888 (25%) patients died, 100 (35.5%) with sepsis and 122 (20.1%) without sepsis ( P  < 0.001). Among survivors, there was no difference for the incidence of new disability at 6 months with or without sepsis, 42/106 (39.6%) and 106/300 (35.3%) (RD, 0.00 (− 10.29 to 10.40), P  = 0.995), respectively. In addition, there was no difference in the severity of disability, health-related quality of life, anxiety and depression, post-traumatic stress, return to work, financial distress or cognitive function. Conclusions Compared to mechanically ventilated patients of similar acuity and length of stay without sepsis, patients with sepsis admitted to ICU have an increased risk of death, but survivors have a similar risk of new disability at 6 months. Trial registration NCT03226912, registered July 24, 2017.