ART-123 is a safe intervention in critically ill patients with sepsis and suspected disseminated intravascular coagulation. The study provided evidence suggestive of efficacy supporting further development of this drug in sepsis-associated coagulopathy including disseminated intravascular coagulation. Future study should focus on using ART-123 in the subgroup of patients most likely to respond to this agent.

Compared with systemic heparin anticoagulation, regional citrate anticoagulation significantly increases hemofilter survival time, and significantly decreases bleeding risk in critically ill patients suffering from acute renal failure and requiring continuous renal replacement therapy.

Background Critically ill patients commonly experience skeletal muscle wasting that may predict clinical outcome. Ultrasound is a noninvasive method that can measure muscle quadriceps muscle layer thickness (QMLT) and subsequently lean body mass (LBM) at the bedside. However, currently the reliability of these measurements are unknown. The objectives of this study were to evaluate the intra- and interreliability of measuring QMLT using bedside ultrasound. Methods Ultrasound measurements of QMLT were conducted at 7 centers on healthy volunteers. Trainers were instructed to perform measurements twice on each patient, and then a second trainee repeated the measurement. Intrarater reliability measured how consistently the same person measured the subject according to intraclass correlation (ICC). Interrater reliability measured how consistently trainer and trainee agreed when measuring the same subject according to the ICC. Results We collected 42 pairs of within operator measurements with an ICC of .98 and 78 pairs of trainer-to-trainee measurements with an ICC of .95. There were no statistically significant differences between the trainer and trainee results (trainer and trainee mean = −0.028 cm, 95% CI = −0.067 to −0.011, P = .1607). Conclusions Excellent intra- and interrater reliability for ultrasound measurements of QMLT in healthy volunteers was observed when performed by a range of providers with no prior ultrasound experience, including dietitians, nurses, physicians, and research assistants. This technique shows promise as a method to evaluate LBM status in ICU or hospital settings and as a method to assess the effects of nutrition and exercise-based interventions on muscle wasting.

In this multicenter observational study, we found that most substitute decision-makers for ICU patients wanted to share decision-making responsibility with physicians and that, overall, they were satisfied with their decision-making experience. Adequate communication, feeling supported, and achieving the appropriate level of care for their family member were key determinants of satisfaction with decision-making in the ICU.

Writing Committee for the REMAP-CAP Investigators IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONSThe immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURESThe primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11...

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Objective To assess the efficacy of therapeutic plasma exchange (TPE) following life-threatening COVID-19. Design, setting, and participants Open-label, randomized clinical trial of intensive care unit (ICU) patients with life-threatening COVID-19 [positive real-time-polymerase-chain-reaction test, plus acute respiratory distress syndrome (ARDS), sepsis, organ failure, hyperinflammation]. The study was terminated after 87/120 patients were enrolled. Intervention and randomization Standard treatment plus TPE (n = 43) versus standard treatment (n = 44), and stratified by peripheral arterial oxygen saturation/fraction of inspired oxygen (PaO 2 /FiO 2 ) ratio (> 150 versus ≤ 150). Main Outcomes and measures Primary outcomes were 35-day mortality and TPE safety. Secondary outcomes were association between TPE and mortality, improvement in Sequential Organ Function Assessment (SOFA) score, change in inflammatory biomarkers, days on mechanical ventilation (MV), and ICU length-of-stay. Results Eighty-seven patients [median years of age 49 (IQR: 34-63); 72 males (82.8%)] were randomized [44 to standard care; 43 to standard care plus TPE]. Days on MV (p=0.007) and ICU length-of-stay (p=0.02) were lower in the TPE group versus controls. Thirty-five-day mortality was lower in the TPE group (20.9% vs. 34.1% in controls), but this did not reach statistical significance [Kaplan-Meir analysis: p=0.582). TPE was associated with increased lymphocytes and ADAMTS-13 activity; plus decreased serum lactate, lactate dehydrogenase, ferritin, D-dimers, and interleukin-6. Multivariable regression analysis provided several predictors of 35-day mortality: PaO 2 /FiO 2 ratio [hazard ratio (HR): 0.98, 95% CI: 0.96-1.00, p=0.02], ADAMTS-13 activity (HR: 0.89, 95% CI: 0.82-0.98, p=0.01), and PE (HR: 3.57, 95% CI: 1.43-8.92, p=0.007). Post-hoc analysis revealed a significant reduction in SOFA score for TPE patients (p<0.05) compared to controls. Conclusion In critically ill COVID-19 patients the addition of TPE to standard ICU therapy was associated with faster clinical recovery and no increased 35-day mortality.

Background: Multiple organ dysfunction syndrome (MODS) is a major cause of mortality in intensive care units. A breakdown in gut barrier function and immune dysfunction are associated with the onset of MODS. Probiotic bacteria have been shown to modulate intestinal barrier and immune function. Objective: This study assessed the efficacy of a probiotic compound in a viable and nonviable formulation in modulating intestinal permeability and immune function and preventing the onset of MODS in patients in the intensive care unit. Design: A double-blind, randomized controlled trial was conducted in the intensive care unit of a tertiary care teaching hospital. Twentyeight critically ill patients admitted to the intensive care unit were randomly assigned to receive 1 of 3 treatments daily for 7 d: 1) placebo, 2) viable probiotics, or 3) equivalent probiotic sonicates. MODS scores and systemic concentrations of immunoglobulin (Ig) A and IgG were measured on days Ҁ1, 4, and 7, and intestinal permeability measurements were taken daily. Results:The patients responded to viable probiotics with a significantly larger increase in systemic IgA and IgG concentrations than in the patients who received placebo or sonicates (P 0.05). MODS scores were not significantly affected by probiotic treatment. Over the study period, intestinal permeability decreased in most patients. Conclusion: Patients receiving viable probiotics show a greater enhancement in immune activity than do patients receiving either placebo or probiotic bacterial sonicates.Am J Clin Nutr 2007; 85:816 -23.