Madsen, Bo

Introduction Sepsis is a global health priority with nearly 50 million cases annually. Cardiovascular dysfunction is common, frequently manifesting as hypotension that persists despite fluid resuscitation. Most affected patients require the use of intravenous (IV) vasoactive agents, typically necessitating intensive care unit (ICU)-level monitoring, invasive interventions and contributing substantially to healthcare costs. Midodrine, an oral alpha-1 agonist approved for orthostatic hypotension, has increasingly been used off-label as a vasopressor-sparing (reducing IV vasopressor use) strategy in sepsis, despite limited and inconsistent evidence. This pragmatic, randomised, open-label trial evaluates the efficacy and safety of midodrine in patients with sepsis-associated hypotension. We hypothesise that, compared with standard care, midodrine administration will reduce the duration of IV vasopressor use. Methods and analysis A total of 308 adult patients with sepsis-associated hypotension will be enrolled (154 per arm). The intervention group will, in addition to standard of care, receive enteral midodrine 10 mg three times daily. Outcomes will be ascertained pragmatically via electronic health record-based data retrieval and adjudicated by research coordinators blinded to treatment assignment. The primary outcome is time alive and off IV vasopressors in the first 28 days (in hours) after randomisation. Secondary outcomes include cumulative vasopressor exposure; use and duration of central venous access; cumulative fluid balance over the first 48 hours and up to 7 days of ICU stay; ICU and hospital length of stay; and ICU-, hospital-, and organ support-free days through day 28. Safety outcomes include adverse events potentially attributable to midodrine during hospitalisation including acute kidney injury. Primary analyses will follow an intention-to-treat framework, including all randomised participants according to their assigned treatment groups. Primary and secondary outcomes will be compared using a van Elteren test stratified by randomisation factors. A predefined secondary Bayesian analysis of the primary outcome will provide complementary estimates of treatment effect. Safety outcomes will be summarised descriptively without formal between-arm hypothesis testing. Ethics and dissemination The Mayo Clinic Institutional Review Board approved this protocol and required written informed consent from all participants (IRB# 24–0 00 121). Findings will be disseminated through peer-reviewed publications and international conference presentations. Trial registration number NCT06319248 .

Objective The aim of this study is to investigate the association between emergency department (ED) organizational models and the risk of death within 7 days of ED discharge. Patients and methods We included Danish ED discharges between 1 January 2011 and 24 December 2014 that led to death within 7 days of discharge. The inclusion criterion was age older than 18 years. The exclusion criterion was further in-hospital admission. First model (Virtual): other departments employ interns who perform ED tasks. They are responsible for ED patient care and prioritize their task order between their own department and the ED. Second model (Hybrid): the ED/other departments perform tasks; interns/consultants are employed by the ED/other departments. The ED/other departments have patient care responsibility. Third model (Independent): the ED performs all tasks; employs interns/consultants; and have patient care responsibility. Sex, age, Charlson Comorbidity Index score, and primary diagnosis were used to describe patient characteristics. We calculated the risk of death within 7 days of discharge using multiple logistic regression analysis. Results In 805 out of 201 299 discharges included in the study, the patient died within 7 days. Compared with the Virtual model, the odds ratio for death within 7 days of discharge was 0.72 (95% confidence interval: 0.59–0.92) for the Independent model and 0.75 (95% confidence interval: 0.61–0.92) for the Hybrid+Virtual model. Increased risk was associated with male sex, older age, and a medium or a high Charlson Comorbidity Index score. Conclusion Compared with discharges from a Virtual model, the risk of death within 7 days of discharge was lower if the ED had an Independent or a Hybrid+Virtual model.

Introduction Twenty-one new Danish emergency departments (EDs) were established following a 2007 policy reform that included ED autonomy to self-organize. The aim of this study was to describe the organization of the 21 departments and their organizational challenges. Participants and methods We used a qualitative design based on COREQ guidelines. All 21 EDs participated, and 123 semi-structured interviews with hospital and ED leaders, physicians, nurses, and secretaries were performed between 2013 and 2015. We used the framework matrix method to investigate the ED goals, setting, structure, staff, task coordination, and incentive structure. Results We identified three generic models (virtual, hybrid, and independent). All had goals of high quality of care and high efficiency. The virtual model was staffed by junior physicians and tasks were coordinated by other departments. The hybrid model was staffed by junior physicians and senior physicians according to other departments and the ED. The ED coordinated all activities. The independent model was staffed by junior physicians and senior physicians, and activities were coordinated by the ED. Of the EDs, 19 utilized different organizational models at different times during a 24-h period and on weekdays and weekends. The main challenge of the virtual and hybrid models was high dependency on other departments. The main challenge of the independent model was establishing a high level of quality of emergency medicine. Discussion and conclusion We identified three organizational ED models (virtual, hybrid, and independent). Nineteen EDs used more than one organizational model depending on the time of day or day of the week.