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Objective Effective pharmacologic treatments directly targeting lung injury in patients with the acute respiratory distress syndrome (ARDS) are lacking. Early treatment with inhaled corticosteroids and beta agonists may reduce progression to ARDS by reducing lung inflammation and enhancing alveolar fluid clearance. Design Double-blind, randomized clinical trial (ClinicalTrials.gov: NCT01783821). The primary outcome was longitudinal change in oxygen saturation divided by the fraction of inspired oxygen (S/F) through day 5. We also analyzed categorical change in S/F by > 20%. Other outcomes included need for mechanical ventilation and development of ARDS. Setting Five academic centers in the United States. Patients Adult patients admitted through the emergency department at risk for ARDS. Interventions Aerosolized budesonide/formoterol vs. placebo twice daily for up to 5 days. Measurements and Main Results Sixty-one patients were enrolled from September 3, 2013 to June 9, 2015. Median time from presentation to first study drug was < 9 hours. More patients in the control group had shock at enrollment (14 vs 3 patients). The longitudinal increase in S/F was greater in the treatment group (p=0.02) and independent of shock (p=0.04). Categorical change in S/F improved (p=0.01) but not after adjustment for shock (p=0.15). More patients in the placebo group developed ARDS (7 versus 0) and required mechanical ventilation (53% versus 21%). Conclusions Early treatment with inhaled budesonide/formoterol in patients at-risk for ARDS is feasible and improved oxygenation as assessed by S/F. These results support further study to test the efficacy of inhaled corticosteroids and beta agonists for prevention of ARDS.

A video depicting cardiopulmonary resuscitation and explaining resuscitation preference options was associated with improved knowledge of in-hospital cardiopulmonary resuscitation options and cardiopulmonary resuscitation terminology among patients and surrogate decision makers in the ICU, compared with receiving a pamphlet on cardiopulmonary resuscitation. Patients and surrogates found the video helpful in decision making and would recommend the video to others.

Objectives In the Fluid and Catheter Treatment Trial (FACTT) of the National Institutes of Health Acute Respiratory Distress Syndrome Network, a conservative fluid protocol (FACTT Conservative) resulted in a lower cumulative fluid balance and better outcomes than a liberal fluid protocol (FACTT Liberal). Subsequent Acute Respiratory Distress Syndrome Network studies used a simplified conservative fluid protocol (FACTT Lite). The objective of this study was to compare the performance of FACTT Lite, FACTT Conservative, and FACTT Liberal protocols. Design Retrospective comparison of FACTT Lite, FACTT Conservative, and FACTT Liberal. Primary outcome was cumulative fluid balance over 7 days. Secondary outcomes were 60-day adjusted mortality and ventilator-free days through day 28. Safety outcomes were prevalence of acute kidney injury and new shock. Setting ICUs of Acute Respiratory Distress Syndrome Network participating hospitals. Patients Five hundred three subjects managed with FACTT Conservative, 497 subjects managed with FACTT Liberal, and 1,124 subjects managed with FACTT Lite. Interventions Fluid management by protocol. Measurements and Main Results Cumulative fluid balance was 1,918 ± 323 mL in FACTT Lite, −136 ±491 mL in FACTT Conservative, and 6,992 ± 502 mL in FACTT Liberal (p < 0.001). Mortality was not different between groups (24% in FACTT Lite, 25% in FACTT Conservative and Liberal, p = 0.84). Ventilator-free days in FACTT Lite (14.9 ±0.3) were equivalent to FACTT Conservative (14.6±0.5) (p = 0.61) and greater than in FACTT Liberal (12.1 ±0.5, p < 0.001 vs Lite). Acute kidney injury prevalence was 58% in FACTT Lite and 57% in FACTT Conservative (p = 0.72). Prevalence of new shock in FACTT Lite (9%) was lower than in FACTT Conservative (13%) (p = 0.007 vs Lite) and similar to FACTT Liberal (11%) (p = 0.18 vs Lite). Conclusions FACTT Lite had a greater cumulative fluid balance than FACTT Conservative but had equivalent clinical and safety outcomes. FACTT Lite is an alternative to FACTT Conservative for fluid management in Acute Respiratory Distress Syndrome.

IntroductionAcute lung injury (ALI) is a devastating condition that places a heavy burden on public health resources. Although the need for effective ALI prevention strategies is increasingly recognised, no effective preventative strategies exist. The Lung Injury Prevention Study with Aspirin (LIPS-A) aims to test whether aspirin (ASA) could prevent and/or mitigate the development of ALI.Methods and analysisLIPS-A is a multicentre, double-blind, randomised clinical trial testing the hypothesis that the early administration of ASA will result in a reduced incidence of ALI in adult patients at high risk. This investigation will enrol 400 study participants from 14 hospitals across the USA. Conditional logistic regression will be used to test the primary hypothesis that early ASA administration will decrease the incidence of ALI.Ethics and disseminationSafety oversight will be under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained from the DSMB prior to enrolling the first study participant. Approval of both the protocol and informed consent documents were also obtained from the institutional review board of each participating institution prior to enrolling study participants at the respective site. In addition to providing important clinical and mechanistic information, this investigation will inform the scientific merit and feasibility of a phase III trial on ASA as an ALI prevention agent. The findings of this investigation, as well as associated ancillary studies, will be disseminated in the form of oral and abstract presentations at major national and international medical specialty meetings. The primary objective and other significant findings will also be presented in manuscript form. All final, published manuscripts resulting from this protocol will be submitted to Pub Med Central in accordance with the National Institute of Health Public Access Policy.