Objectives: To assess the safety of Auxora in patients with acute pancreatitis (AP), systemic inflammatory response syndrome (SIRS), and hypoxemia, and identify efficacy endpoints to prospectively test in future studies. Methods: This phase 2, open-label, dose-response study randomized patients with AP, accompanying SIRS, and hypoxemia (n = 21) to receive low-dose or high-dose Auxora plus standard of care (SOC) or SOC alone. All patients received pancreatic contrast-enhanced computed tomography scans at screenings, day 5/discharge, and as clinically required 90 days postrandomization; scans were blinded and centrally read to determine AP severity using computed tomography severity index. Solid food tolerance was assessed at every meal and SIRS every 12 hours. Results: The number of patients experiencing serious adverse events was not increased with Auxora versus SOC alone. Three (36.5%) patients with moderate AP receiving low-dose Auxora improved to mild AP; no computed tomography severity index improvements were observed with SOC. By study end, patients receiving Auxora better tolerated solid foods, had less persistent SIRS, and had reduced hospitalization versus SOC. Conclusions: The favorable safety profile and patient outcomes suggest Auxora may be an appropriate early treatment for patients with AP and SIRS. Clinical development will continue in a randomized, controlled, blinded, dose-ranging study.
Objectives: Sodium zirconium cyclosilicate (SZC) is a novel, highly selective potassium binder currently approved in the United States and European Union for treatment of hyperkalemia. This pilot evaluation explored the efficacy of SZC with insulin and glucose as hyperkalemia treatment in the emergency department (ED).Methods: This exploratory, phase II, multicenter, randomized, double‐blind, placebo‐controlled study (NCT03337477) enrolled adult ED patients with blood potassium ≥ 5.8 mmol/L. Patients were randomized 1:1 to receive SZC 10 g or placebo, up to three times during a 10‐hour period, with insulin and glucose. The primary efficacy outcome was the mean change in serum potassium (sK+) from baseline until 4 hours after start of dosing.Results: Overall, 70 patients were randomized (SZC n = 33, placebo n = 37), of whom 50.0% were male. Their mean (± standard deviation [±SD]) age was 59.0 (±13.8) years and mean initial sK+ was similar between groups (SZC 6.4 mmol/L, placebo 6.5 mmol/L). The least squares mean (±SD) sK+ change from baseline to 4 hours was –0.41 (±0.11) mmol/L and –0.27 (±0.10) mmol/L with SZC and placebo, respectively (difference = –0.13 mmol/L, 95% confidence interval [CI] = –0.44 to 0.17). A greater reduction in mean (±SD) sK+ from baseline occurred with SZC compared with placebo at 2 hours: –0.72 (±0.12) versus –0.36 (±0.11) mmol/L (LSM difference = –0.35 mmol/L, 95% CI = –0.68 to –0.02), respectively. A numerically lower proportion of patients in the SZC group required additional potassium‐lowering therapy due to hyperkalemia at 0 to 4 hours versus placebo (15.6% vs. 30.6%, respectively; odds ratio = 0.40, 95% CI = 0.09 to 1.77). Comparable proportions of patients experienced adverse events in both treatment groups at 0 to 24 hours.Conclusions: This pilot study suggested that SZC with insulin and glucose may provide an incremental benefit in the emergency treatment of hyperkalemia over insulin and glucose alone.
Mobile health (mHealth) has the potential to change how patients make healthcare decisions. We sought to determine the readiness to use mHealth technology in underserved communities. We conducted a cross-sectional survey of patients presenting with low-acuity complaints to an urban emergency department (ED) with an underserved population. Patients over the age of two who presented with low-acuity complaints were included. We conducted structured interview with each patient or parent (for minors) about willingness to use mHealth tools for guidance. Analysis included descriptive statistics and univariate analysis based on age and gender. Of 560 patients included in the survey, 80% were adults, 64% female, and 90% Black. The mean age was 28 ± 9 years for adults and 9 ± 5 years for children. One-third of patients reported no primary care physician, and 55% reported no access to a nurse or clinician for medical advice. Adults were less likely to have access to phone consultation than parents of children (odds ratio [OR] 0.49, 95% confidence interval [CI], 0.32 - 0.74), as were males compared to females (OR 0.52, 95% CI, 0.37-0.74). Most patients (96%) reported cellular internet access. Two-thirds of patients reported using online references. When asked how they would behave if an mHealth tool advised them that their current health problem was low risk, 69% of patients responded that they would seek care in an outpatient clinic instead of the ED (30%), stay home and not seek urgent medical care (28%), or use telehealth (11%). In this urban community we found a large capacity and willingness to use mHealth technology in medical triage.
Hypertensive emergencies cause substantial morbidity and mortality, particularly when acute organ injury is present. Careful and effective strategies to reduce blood pressure and diminish the effects of pressure-mediated injury are essential. While the selection of specific antihypertensive medications varies little across different forms of hypertensive emergencies, the intensity of blood pressure reduction to the target pressure differs substantially. Treatment hinges on balancing the positive effects of lowering blood pressure with the potential for negative effects of organ hypoperfusion in patients with altered autoregulatory mechanisms. When patients do not have acute organ injury in addition to severe hypertension, they benefit from a conservative, outpatient approach to blood pressure management. In all cases, long term control of blood pressure is paramount to prevent recurrent hypertensive emergencies and improve overall prognosis. This review discusses the current evidence and guidelines on the evaluation and management of hypertensive emergency.
1 June 2012 in The American Journal of Emergency Medicine