Effect of selective decontamination of the digestive tract on hospital mortality in critically Ill patients receiving mechanical ventilation a randomized clinical trial

Importance Whether selective decontamination of the digestive tract (SDD) reduces mortality in critically ill patients remains uncertain. Objective To determine whether SDD reduces in-hospital mortality in critically ill adults. Design, Setting, and Participants A cluster, crossover, randomized clinical trial that recruited 5982 mechanically ventilated adults from 19 intensive care units (ICUs) in Australia between April 2018 and May 2021 (final follow-up, August 2021). A contemporaneous ecological assessment recruited 8599 patients from participating ICUs between May 2017 and August 2021. Interventions ICUs were randomly assigned to adopt or not adopt a SDD strategy for 2 alternating 12-month periods, separated by a 3-month interperiod gap. Patients in the SDD group (n = 2791) received a 6-hourly application of an oral paste and administration of a gastric suspension containing colistin, tobramycin, and nystatin for the duration of mechanical ventilation, plus a 4-day course of an intravenous antibiotic with a suitable antimicrobial spectrum. Patients in the control group (n = 3191) received standard care. Main Outcomes and Measures The primary outcome was in-hospital mortality within 90 days. There were 8 secondary outcomes, including the proportion of patients with new positive blood cultures, antibiotic-resistant organisms (AROs), and Clostridioides difficile infections. For the ecological assessment, a noninferiority margin of 2% was prespecified for 3 outcomes including new cultures of AROs. Results Of 5982 patients (mean age, 58.3 years; 36.8% women) enrolled from 19 ICUs, all patients completed the trial. There were 753/2791 (27.0%) and 928/3191 (29.1%) in-hospital deaths in the SDD and standard care groups, respectively (mean difference, −1.7% [95% CI, −4.8% to 1.3%]; odds ratio, 0.91 [95% CI, 0.82-1.02]; P = .12). Of 8 prespecified secondary outcomes, 6 showed no significant differences. In the SDD vs standard care groups, 23.1% vs 34.6% had new ARO cultures (absolute difference, −11.0%; 95% CI, −14.7% to −7.3%), 5.6% vs 8.1% had new positive blood cultures (absolute difference, −1.95%; 95% CI, −3.5% to −0.4%), and 0.5% vs 0.9% had new C difficile infections (absolute difference, −0.24%; 95% CI, −0.6% to 0.1%). In 8599 patients enrolled in the ecological assessment, use of SDD was not shown to be noninferior with regard to the change in the proportion of patients who developed new AROs (−3.3% vs −1.59%; mean difference, −1.71% [1-sided 97.5% CI, −∞ to 4.31%] and 0.88% vs 0.55%; mean difference, −0.32% [1-sided 97.5% CI, −∞ to 5.47%]) in the first and second periods, respectively. Conclusions and Relevance Among critically ill patients receiving mechanical ventilation, SDD, compared with standard care without SDD, did not significantly reduce in-hospital mortality. However, the confidence interval around the effect estimate includes a clinically important benefit. Trial Registration ClinicalTrials.gov Identifier: NCT0238903

Communication with Families Regarding Organ and Tissue Donation after Death in Intensive Care (COMFORT): A multicentre before-and-after study

© 2018, Australasian Medical Publishing co. All rights reserved. Objective: To implement a best-practice intervention offering deceased organ donation, testing whether it increased family consent rates. Design: A multicentre before-and-after study of a prospective cohort compared with pre-intervention controls. Setting: Nine Australian intensive care units. Participants: Families and health care professionals caring for donor-eligible patients without registered donation preferences or aged ≤ 16 years. Intervention: A multicomponent intervention including offers of deceased organ donation from specially trained designated requesters using a structured conversation separate to end-of-life discussions. Main outcome measure: Proportion of families consenting to organ donation. Results: Consent was obtained in 87/164 cases (53%) during the intervention period compared with 14/25 cases (56%) pre-intervention (P = 0.83). The odds ratio (OR) of obtaining consent during the intervention period relative to pre-intervention was 1.13 (95% CI, 0.48–2.63; P = 0.78). During the intervention period, designated requesters obtained consent in 55/98 cases (56%), compared with 32/66 cases (48%) in which the medical team managing patient care raised donation (P = 0.34). Factors independently associated with increased consent were: family-raised organ donation (OR, 4.34; 95% CI, 1.79–10.52; P = 0.001), presence of an independent designated requester (OR, 3.84; 95% CI, 1.35– 10.98; P = 0.012), and multiple donation conversations per case (OR, 3.35; 95% CI, 1.93–5.81; P < 0.001). Consent decreased when patients were of non-Christian religion (OR, 0.18; 95% CI, 0.04–0.91; P = 0.038) and end-of-life and donation meetings were separate (OR, 0.38; 95% CI, 0.16–0.89; P = 0.026). Conclusion: Implementation of a multicomponent intervention did not increase consent rates for organ donation, although some components of the intervention exerted significant effect

Early sedation with dexmedetomidine in ventilated critically ill patients and heterogeneity of treatment effect in the SPICE III randomised controlled trial

PurposeTo quantify potential heterogeneity of treatment effect (HTE), of early sedation with dexmedetomidine (DEX) compared with usual care, and identify patients who have a high probability of lower or higher 90-day mortality according to age, and other identified clusters.MethodsBayesian analysis of 3904 critically ill adult patients expected to receive invasive ventilation &gt; 24 h and enrolled in a multinational randomized controlled trial comparing early DEX with usual care sedation.ResultsHTE was assessed according to age and clusters (based on 12 baseline characteristics) using a Bayesian hierarchical models. DEX was associated with lower 90-day mortality compared to usual care in patients &gt; 65 years (odds ratio [OR], 0.83 [95% credible interval [CrI] 0.68–1.00], with 97.7% probability of reduced mortality across broad categories of illness severity. Conversely, the probability of increased mortality in patients ≤ 65 years was 98.5% (OR 1.26 [95% CrI 1.02–1.56]. Two clusters were identified: cluster 1 (976 patients) mostly operative, and cluster 2 (2346 patients), predominantly non-operative. There was a greater probability of benefit with DEX in cluster 1 (OR 0.86 [95% CrI 0.65–1.14]) across broad categories of age, with 86.4% probability that DEX is more beneficial in cluster 1 than cluster 2.ConclusionIn critically ill mechanically ventilated patients, early sedation with dexmedetomidine exhibited a high probability of reduced 90-day mortality in older patients regardless of operative or non-operative cluster status. Conversely, a high probability of increased 90-day mortality was observed in younger patients of non-operative status. Further studies are needed to confirm these findings.Take home messageThe early use of dexmedetomidine for sedation of ventilated critically ill patients who are older than 65 years, and in those with an operative diagnosis, across broad range of age categories, has a high probability of reduced mortality. Conversely, younger patients with a non-operative diagnosis have a high probability of increased mortality. Thus, the early use of dexmedetomidine in this group of patients, outside controlled research, is not advised

Sociodemographic Variation in the Perception of Barriers to Exercise Among Japanese Adults

Background: The perception of barriers to exercise is an important correlate of exercise participation. However, only a limited number of studies-mostly from Western countries-have attempted to describe the perceptions of barriers to exercise in specific population groups. This study examined the associations between sociodemographic attributes and perceived barriers to exercise in Japanese adults. Methods: A population-based cross sectional study of 865 participants (age: 20-69 years old, men: 46.5%) was conducted in 4 cities in Japan. Nine sociodemographic attributes (sex, age, location of residence, educational attainment, marital status, employment status, presence of dependents in the household, self-rated health, body mass index), along with exercise frequency and perception of barriers to exercise (discomfort, lack of motivation, lack of time, lack of social support, poor environment) were assessed by self-administered questionnaire. Results: The most strongly perceived barrier was lack of time. Five of 9 sociodemographic attributes were significantly related to certain types of perceived barriers. Participants who more strongly perceived barriers were younger, more highly educated, more likely to be employed, and had relatively poor self-rated health and a high BMI. The specific types of barriers that were strongly perceived varied with the sociodemographic attributes of the participants. Conclusions: The results show that the perception of barriers to exercise varies among specific population groups, which indicates the importance of targeting exercise promotion strategies to specific populations