Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Empathic processes during nurse-consumer conflict situations in psychiatric inpatient units: A qualitative study

Empathy is a central component of nurse-consumer relationships. In the present study, we investigated how empathy is developed and maintained when there is conflict between nurses and consumers, and the ways in which empathy can be used to achieve positive outcomes. Through semistructured interviews, mental health nurses (n = 13) and consumers in recovery (n = 7) reflected on a specific conflict situation where they had experienced empathy, as well as how empathy contributed more generally to working with nurses/consumers. Thematic analysis was used to analyse the data, utilizing a framework that conceptualizes empathy experiences as involving antecedents, processes, and outcomes. The central theme identified was 'my role as a nurse - the role of my nurse'. Within this theme, nurses focussed on how their role in managing risk and safety determined empathy experienced towards consumers; consumers saw the importance of nurse empathy both in conflict situations and for their general hospitalization experience. Empathy involved nurses trying to understand the consumer's perspective and feeling for the consumer, and was perceived by consumers to involve nurses 'being there'. Empathic relationships built on trust and rapport could withstand a conflict situation, with empathy a core component in consumer satisfaction regarding conflict resolution and care. Empathy allows the maintenance of therapeutic relationships during conflict, and influences the satisfaction of nurses and consumers, even in problematic situations. Nurse education and mentoring should focus on nurse self-reflection and building empathy skills in managing conflict. © 2016 Australian College of Mental Health Nurses Inc