11 research outputs found
A Systematic Review and International Web-Based Survey of Randomized Controlled Trials in the Perioperative and Critical Care Setting: Interventions Reducing Mortality
The authors aimed to identify interventions documented by randomized controlled trials (RCTs) that reduce mortality in adult critically ill and perioperative patients, followed by a survey of clinicians’ opinions and routine practices to understand the clinicians’ response to such evidence. The authors performed a comprehensive literature review to identify all topics reported to reduce mortality in perioperative and critical care settings according to at least 2 RCTs or to a multicenter RCT or to a single-center RCT plus guidelines. The authors generated position statements that were voted on online by physicians worldwide for agreement, use, and willingness to include in international guidelines. From 262 RCT manuscripts reporting mortality differences in the perioperative and critically ill settings, the authors selected 27 drugs, techniques, and strategies (66 RCTs, most frequently published by the New England Journal of Medicine [13 papers], Lancet [7], and Journal of the American Medical Association [5]) with an agreement ≥67% from over 250 physicians (46 countries). Noninvasive ventilation was the intervention supported by the largest number of RCTs (n = 13). The concordance between agreement and use (a positive answer both to “do you agree” and “do you use”) showed differences between Western and other countries and between anesthesiologists and intensive care unit physicians. The authors identified 27 clinical interventions with randomized evidence of survival benefit and strong clinician support in support of their potential life-saving properties in perioperative and critically ill patients with noninvasive ventilation having the highest level of support. However, clinician views appear affected by specialty and geographical location
High Risk of Secondary Infections Following Thrombotic Complications in Patients With COVID-19
Background. This study’s primary aim was to evaluate the impact of thrombotic complications on the development of secondary infections. The secondary aim was to compare the etiology of secondary infections in patients with and without thrombotic complications. Methods. This was a cohort study (NCT04318366) of coronavirus disease 2019 (COVID-19) patients hospitalized at IRCCS San Raffaele Hospital between February 25 and June 30, 2020. Incidence rates (IRs) were calculated by univariable Poisson regression as the number of cases per 1000 person-days of follow-up (PDFU) with 95% confidence intervals. The cumulative incidence functions of secondary infections according to thrombotic complications were compared with Gray’s method accounting for competing risk of death. A multivariable Fine-Gray model was applied to assess factors associated with risk of secondary infections. Results. Overall, 109/904 patients had 176 secondary infections (IR, 10.0; 95% CI, 8.8–11.5; per 1000-PDFU). The IRs of secondary infections among patients with or without thrombotic complications were 15.0 (95% CI, 10.7–21.0) and 9.3 (95% CI, 7.9–11.0) per 1000-PDFU, respectively (P = .017). At multivariable analysis, thrombotic complications were associated with the development of secondary infections (subdistribution hazard ratio, 1.788; 95% CI, 1.018–3.140; P = .043). The etiology of secondary infections was similar in patients with and without thrombotic complications. Conclusions. In patients with COVID-19, thrombotic complications were associated with a high risk of secondary infections
Technical and Operational Issues Associated with Early Warning Zones for Critical Infrastructure
This document captures the work performed during the current phase of the Early Warning Zones (EWZ) Project. The aim of the Early Warning Zones Project has been to explore the technical and operational issues associated with providing an early warning zone around Critical Infrastructures (CI’s). Seven key areas of technical and operational issues have been explored and documented in this report. These are EWZ Use cases; Biometric Recognition for EWZ; Standardization Challenges for EWZ; Video and Cognitive Surveillance Challenges for EWZ; EWZ Policy Options and Design Requirements; Data Protection Impact Assessment and Prototype Development; and Guidance for implementing EWZ. It is noted that this subject is still at an early stage of investigation and the intention has been to make sure that all of the activity performed by the group has been captured in this report under the separate tasks. It is also apparent that there would be many fruitful areas of future research activity that could follow from a deeper and more integrated follow on stage for this project.JRC.E.2-Technology Innovation in Securit
Late gadolinium enhancement as a predictor of functional recovery, need for defibrillator implantation and prognosis in non-ischemic dilated cardiomyopathy
Background Aim of the study was to investigate whether late gadolinium enhancement (LGE) at cardiac magnetic resonance (CMR) predict reverse remodeling (RR) in non-ischemic dilated cardiomyopathy (NIDCM). Methods Seventy-one NIDCM patients (age 57 ± 14 years, 43 males, median left ventricular ejection fraction [LVEF] 35%, [interquartile range 27â\u80\u9341%]) with two CMR scans within 5 years were included. RR was defined as â\u89¥ 10% reduction in left ventricular (LV) end-diastolic volume and â\u89¥ 10% LVEF increase. The end-point was a composite of all-cause death, cardiovascular hospitalization or appropriate defibrillator discharge. LGE was assessed both visually and as percentage of LV mass (LGE%). Results LGE was present in 42 patients (59%). During the interval between the 2 CMR scans (median 28 [15â\u80\u9344] months), 22 patients (31%) displayed RR. LGE absence predicted RR irrespectively of baseline LV volumes and LVEF. Over a median 42[15â\u80\u9373]-month follow-up, the endpoint occurred in 36 patients (51%). LGE absence was associated with better prognosis (P = 0.043), with best quantitative LGE cut-point < 7% at ROC analysis (P = 0.017), but RR was the strongest prognostic predictor. Among 35 patients with baseline LVEF < 35%, 25 (69%) crossed the 35% LVEF threshold. Both LGE absence and quantitative LGE < 7% were associated with crossing of the 35% LVEF threshold for defibrillator implantation; patients with either LGE or quantitative LGE â\u89¥ 7% had a worse prognosis. Conclusions In NIDCM, the absence of LGE at baseline CMR is associated with RR. When baseline LVEF is < 35%, LGE absence is associated with more frequent crossing of the 35% LVEF threshold for defibrillator implantation
Four Decades of Randomized Clinical Trials Influencing Mortality in Critically Ill and Perioperative Patients
Objectives: Randomized clinical trials (RCTs) represent the highest level of scientific evidence. The aim of this review was to map and summarize the main characteristics and publication trends of RCTs with a statistically significant effect on mortality in critically ill and perioperative
patients.
Design: A mapping review of RCTs published between January 1982 and January 2021. The authors searched PubMed/MEDLINE and
EMBASE for RCTs reporting mortality data. A descriptive analysis was conducted, including general and methodologic information of all these
RCTs with a statistically significant difference (p < 0.05) in mortality.
Measurements and Main Results: The authors identified 340 studies published in 115 journals from 42 countries. The most represented clinical
areas were ventilatory support (n = 58, 17%) and hemodynamics (n = 56, 16%). A detrimental effect on survival was described in 47 (14%)
RCTs. Denmark had the highest number of published trials per million inhabitants. A total of 40 (12%) RCTs were led by a female author. The
intention-to-treat principle was applied overall in 60% of RCTs, though this percentage increased up to 75% when the study was published in
journals with high impact factor.
Conclusions: In the largest contemporary RCTs database of interventions significantly influencing mortality, the authors found an increase in scientific production. United States, China, France, Italy, and the United Kingdom contributed with 172 (51%) RCTs over 40 years. Only 20% of the
studies were multinational collaborations, though this percentage increased over time. The presence of women as first authors was 1 out of 8 RCTs.Sin financiación2.894 JCR (2021)Q1, 23/34 Anesthesiology0.582 SJR (2021) Q2, 44/128 Anesthesiology and Pain MedicineNo data IDR 2020UE
Gender-gap in randomized clinical trials reporting mortality in the perioperative setting and critical care: 20 years behind the scenes
Background: Women researchers might experience obstacles in academic environments and might be underrepresented in the authorship of articles published in peer-reviewed journals. Material and Methods: This is a cross-sectional analysis of female-led RCTs describing all interventions reducing mortality in critically ill and perioperative patients from 1981 to December 31, 2020. We searched PubMed/MEDLINE and EMBASE with the keywords RCTs and mortality. The gender of the first author was extracted and descriptive analysis was performed including the year of publication, impact factor, country of the first author, and methodological aspects. Results: We analyzed 340 RCTs, of which 42 (12%) were led by female researchers. The presence of women increased from 8% (14/172) until 2010 up to 17% (28/168) in 2010 and beyond. The United States, the United Kingdom, and Brazil were the main countries of origin of female researchers. Women authors conducted mainly single-center and single-nation studies as compared to male authors. The median impact factor of the target journal was 6 (3-27) in women vs. 7 (3-28) in men, with a p-value of 0.67; Critical Care Medicine, JAMA, and The New England Journal of Medicine were the most frequent target journals for both women and men. Conclusion: In the last 40 years, only one out of eight RCTs had a woman as the first author but the presence of women increased up to 17% by 2010 and beyond. The impact factor of publication target journals was high and not different between genders
Late gadolinium enhancement as a predictor of functional recovery, need for defibrillator implantation and prognosis in non-ischemic dilated cardiomyopathy
A Systematic Review and International Web-Based Survey of Randomized Controlled Trials in the Perioperative and Critical Care Setting: Interventions Increasing Mortality
Reducing mortality is a key target in critical care and perioperative medicine. The authors aimed to identify all nonsurgical interventions (drugs, techniques, strategies) shown by randomized trials to increase mortality in these clinical settings
Accelerated surgery versus standard care in hip fracture (HIP ATTACK-1) : a kidney substudy of a randomized clinical trial
To the Editor: Acute kidney injury (AKI) is a lesser-known complication of hip fracture that may come about owing to decreased kidney perfusion and heightened inflammation from trauma, pain, bleeding, and fasting. Approximately 15%-20% of patients undergoing surgery for a hip fracture develop AKI, with 0.5%-1.8% receiving dialysis. [...
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Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure The ARIES-HM3 Randomized Clinical Trial
IMPORTANCE Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety. OBJECTIVE To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding. DESIGN, SETTING, and PARTICIPANTS This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months. Intervention Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen. MAIN OUTCOMES AND MEASURES The composite primary end point, assessed for noninferiority (−10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events. RESULTS Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (68%) vs those taking aspirin (74%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, −1.6%]; P < .001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P = .002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics. CONCLUSIONS AND RELEVANCE In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0406915