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1.
Ann Intern Med ; 175(9): 1266-1274, 2022 09.
Article in English | MEDLINE | ID: mdl-35939810

ABSTRACT

BACKGROUND: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection. OBJECTIVE: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone. DESIGN: Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978). SETTING: Multinational, multicenter trial. PARTICIPANTS: Adults hospitalized with COVID-19. INTERVENTION: Intravenous ensovibep, 600 mg, or placebo. MEASUREMENTS: Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90. RESULTS: An independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (n = 247) or placebo (n = 238). The odds ratio (OR) for a more favorable pulmonary outcome in the ensovibep (vs. placebo) group at day 5 was 0.93 (95% CI, 0.67 to 1.30; P = 0.68; OR > 1 would favor ensovibep). The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; sHR > 1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR < 1 would favor ensovibep). LIMITATION: The trial was prematurely stopped because of futility, limiting power for the primary outcome. CONCLUSION: Compared with placebo, ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 receiving standard care, including remdesivir; no safety concerns were identified. PRIMARY FUNDING SOURCE: National Institutes of Health.


Subject(s)
COVID-19 Drug Treatment , Adult , Designed Ankyrin Repeat Proteins , Double-Blind Method , Humans , Recombinant Fusion Proteins , SARS-CoV-2 , Treatment Outcome
2.
J Emerg Med ; 65(5): e393-e402, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37722949

ABSTRACT

BACKGROUND: Physical restraints are used in the emergency department (ED) for agitated patients to prevent self-harm and protect staff. Prior studies identified associations between sociodemographic factors and ED physical restraints use. OBJECTIVES: The primary objective was to compare characteristics of ED patients receiving physical restraints for violent and nonviolent indications vs. patients who were not restrained. The secondary objective was to compare rates of restraint use among ED providers. METHODS: This was a single-center cross-sectional study of adult ED patients from March 2019 to February 2021. Factors compared across groups were age over 50 years, gender, race, ethnicity, insurance, housing, primary language, Emergency Severity Index, time of arrival, mode of arrival, chief complaint, and medical admission. Odds ratios were reported. Rates of emergency physician restraint orders were compared using the chi-square test. RESULTS: Restraints were used in 1228 (0.9%) visits. Younger age, male gender, "unknown" ethnicity, self-pay or "other" nonprivate insurance, homelessness, arrival by first responders, and medical hospitalization were associated with increased odds of restraint. Black patients had lower odds of any restraint than White patients (odds ratio 0.93; 95% confidence interval 0.79-1.09) and higher odds of violent restraint than White patients, although not significant (odds ratio 1.55; 95% confidence interval 0.95-2.54). ED providers had significant differences in total and violent restraint use (p-values < 0.0001 and 0.0003, respectively). CONCLUSION: At this institution, certain sociodemographic characteristics were associated with receiving both types of physical restraint. Emergency physicians also differed in restraint-ordering practice. Further investigation is needed to understand the influence of implicit bias on ED restraint use.

3.
Psychiatr Q ; 93(1): 297-310, 2022 03.
Article in English | MEDLINE | ID: mdl-34536188

ABSTRACT

Emergency department (ED) psychiatrists face the consequential decision to pursue involuntary inpatient psychiatric admission. Research on the relationship between patient characteristics and the decision to pursue involuntary psychiatric admission is limited. Using data from 2017 to 2018 at an urban Los Angeles hospital, we used generalized linear mixed effects models to compare patients who were involuntarily admitted to inpatient psychiatry to patients who were discharged from the ED. Of 2,448 patients included in the study, 1,217 (49.7%) were involuntarily admitted to inpatient psychiatry and 1,231 (50.3%) were discharged. After controlling for sociodemographic characteristics, admitted patients were more likely to have been brought in by police, have had an organized suicide plan or recent attempt, physical signs of harm, psychosis, depression or hopelessness, lack social support, have diagnoses of schizophrenia or bipolar disorder, and be administered injectable psychotropic medications. Stimulant use, a diagnosis of anxiety or developmental disorders, and recent medical ED utilization were associated with discharge. Psychiatrists pursued involuntarily psychiatric hospitalization based on factors potentially indicative of dangerousness, leaving patients, particularly those with recent substance use, without immediate access to treatment. Policies should focus on increasing follow up to high quality, voluntary outpatient mental health care.


Subject(s)
Bipolar Disorder , Mental Disorders , Psychiatry , Psychotic Disorders , Commitment of Mentally Ill , Hospitalization , Humans , Mental Disorders/drug therapy , Mental Disorders/therapy
4.
Am J Emerg Med ; 50: 160-166, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34365066

ABSTRACT

STUDY OBJECTIVE: Determine whether an expanded emergency medicine (EM) pharmacist scope of practice reduces the frequency of major delays in subsequent antibiotic administration in patients boarded in the emergency department (ED). METHODS: A pre-post, quasi-experimental study conducted from November 2019-March 2020 at a single-center tertiary academic medical center following the implementation of an expanded EM pharmacist scope of practice. Adult patients were included if they received an initial antibiotic dose in the ED and deemed to be high-risk. Subsequent antibiotic doses were reordered by EM pharmacists for up to 24-h after the initial order pending ED length of stay (LOS). The historical control group consisted of retrospective chart review of cases from the previous year. RESULTS: The study identified that of the 181 participants enrolled, major delays in subsequent antibiotic administration occurred in 13% of the intervention group and 48% of the control group (p < 0.01). When compared to the control group, the intervention group had a significant decrease in the number of delays among antibiotics dosed at 6-h (39% vs 13%) and 8-h (60% vs 8%) intervals. For antibiotics dosed at 12-h intervals, no statistically significant difference was observed between the control and intervention groups respectively (19% vs 5%). A statistically significant lower incidence of in-hospital mortality was observed in the intervention group (3% vs 11%, p = 0.02). In the intervention group, 97% of patients received subsequent antibiotic doses while boarded in the ED, compared to 65% in the control group (<0.01). CONCLUSION: Expanding EM pharmacist scope of practice was associated with a significant reduction in the frequency of major delays in subsequent antibiotic administration as well as a decreased incidence of hospital mortality.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Emergency Service, Hospital , Pneumonia/drug therapy , Practice Patterns, Pharmacists'/statistics & numerical data , Sepsis/drug therapy , Aged , Female , Humans , Length of Stay/statistics & numerical data , Male
5.
J Emerg Med ; 60(4): 444-450, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33414047

ABSTRACT

BACKGROUND: Interruptions are recognized as potentially harmful to safety and efficiency, and are especially prevalent in the emergency department (ED) setting. Policies urging immediate review of all electrocardiograms (ECGs) may lead to numerous and frequent interruptions. OBJECTIVE: We assessed the role of ECG review as a source of ED interruptions to characterize a potential target for interventions. METHODS: We analyzed emergency physician time use during the course of a clinical shift using a time-and-motion design. A research assistant observed a convenience sample of shifts, observing and logging transitions between different tasks using an electronic device. Instances of ECG review were tallied, with start and ending times of ECG review recorded to the nearest second. An ECG review was considered an interruption if the immediate prior and subsequent tasks were the same. RESULTS: Twenty shifts were observed for a total of 149 h. There were 211 ECG reviews, (mean rate 1.4 per hour), with more frequent review among physicians staffing a zone with higher-acuity patients (2.8 per hour), where clustering of multiple ECG reviews in succession was more common. Seventy-five percent of ECG reviews required < 30 s. Of all 211 ECG reviews, 102 (48%) were an interruption. The tasks most frequently interrupted were electronic medical record system use (68 of 102, 67%) and communicating with ED staff in person (18 of 102, 18%). CONCLUSIONS: Review of ECGs was a substantial driver of interruptions for emergency physicians. Interventions to integrate ECG review more naturally into physician workflow may improve patient safety by reducing these interruptions.


Subject(s)
Emergency Service, Hospital , Physicians , Electrocardiography , Humans , Patient Safety , Workflow
6.
Emerg Med J ; 38(4): 304-307, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33602725

ABSTRACT

INTRODUCTION: EDs are often the first line of contact with individuals infected with COVID-19 and play a key role in triage. However, there is currently little specific guidance for deciding when patients with COVID-19 require hospitalisation and when they may be safely observed as an outpatient. METHODS: In this retrospective study, we characterised all patients with COVID-19 discharged home from EDs in our US multisite healthcare system from March 2020 to August 2020, focusing on individuals who returned within 2 weeks and required hospital admission. We restricted analyses to first-encounter data that do not depend on laboratory or imaging diagnostics in order to inform point-of-care assessments in resource-limited environments. Vitals and comorbidities were extracted from the electronic health record. We performed ordinal logistic regression analyses to identify predictors of inpatient admission, intensive care and intubation. RESULTS: Of n=923 patients who were COVID-19 positive discharged from the ED, n=107 (11.6%) returned within 2 weeks and were admitted. In a multivariable-adjusted model including n=788 patients with complete risk factor information, history of hypertension increased odds of hospitalisation and severe illness by 1.92-fold (95% CI 1.07 to 3.41), diabetes by 2.20-fold (1.18 to 4.02), chronic lung disease by 2.21-fold (1.22 to 3.92) and fever by 2.89-fold (1.71 to 4.82). Having at least two of these risk factors increased the odds of future hospitalisation by 6.68-fold (3.54 to 12.70). Patients with hypertension, diabetes, chronic lung disease or fever had significantly longer hospital stays (median 5.92 days, 3.08-10.95 vs 3.21, 1.10-5.75, p<0.01) with numerically higher but not significantly different rates of intensive care unit admission (27.02% vs 14.30%, p=0.27) and intubation (12.16% vs 7.14%, p=0.71). DISCUSSION: Patients infected with COVID-19 may appear clinically safe for home convalescence. However, those with hypertension, diabetes, chronic lung disease and fever may in fact be only 'pseudo-safe' and are most at risk for subsequent hospitalisation with more severe illness and longer hospital stays.


Subject(s)
COVID-19/therapy , Emergency Service, Hospital , Patient Discharge , Age Factors , Ambulatory Care/methods , Ambulatory Care/statistics & numerical data , COVID-19/diagnosis , Critical Care/statistics & numerical data , Emergency Service, Hospital/statistics & numerical data , Humans , Logistic Models , Male , Patient Admission/statistics & numerical data , Patient Discharge/statistics & numerical data , Patient Safety , Respiration, Artificial/statistics & numerical data , Retrospective Studies , Risk Factors , Severity of Illness Index , Triage , United States
7.
Am J Emerg Med ; 36(3): 396-402, 2018 Mar.
Article in English | MEDLINE | ID: mdl-28843518

ABSTRACT

BACKGROUND: Factor Xa (FXa) inhibitors, used for stroke prevention in atrial fibrillation and venous thromboembolism treatment and prevention, are the dominant non-Vitamin K oral anticoagulants on the market. While major bleeding may be less common with these agents compared to warfarin, it is always a risk, and little has been published on the most serious bleeding scenarios. This study describes a cohort of patients with FXa inhibitor-associated life-threatening bleeding events, their clinical characteristics, interventions and outcomes. METHODS: We performed a retrospective, 5-center review of FXa inhibitor-treated major bleeding patients. Investigators identified potential cases by cross-referencing ICD-9/10 codes for hemorrhage with medication lists. Investigators selected cases they deemed to require immediate reversal of coagulopathy, and reviewed charts for characteristics, reversal strategies and other interventions, and outcomes. RESULTS: A total of 56 charts met the inclusion criteria for the retrospective cohort, including 29 (52%) gastrointestinal bleeds (GIB), 19 (34%) intracranial hemorrhages (ICH) and 8 (14%) others. Twenty-four (43%) patients received various factor or plasma products, and the remainder received supportive care. Thirty-day mortality was 21% (n=12). Re-anticoagulation within 30-days occurred in 23 (41%) patients. Thromboembolic events (TEEs) occurred in 6 (11%) patients. No differences were observed in outcomes by treatment strategy. CONCLUSIONS: This cohort of FXa inhibitor-associated major bleeding scenarios deemed appropriate for acute anticoagulant reversal illustrates the variable approaches in the absence of a specific reversal agent.


Subject(s)
Factor Xa Inhibitors/adverse effects , Hemorrhage/chemically induced , Aged , Blood Coagulation Factors/therapeutic use , Female , Gastrointestinal Hemorrhage/chemically induced , Gastrointestinal Hemorrhage/therapy , Hemorrhage/therapy , Heparin, Low-Molecular-Weight/adverse effects , Humans , Intracranial Hemorrhages/chemically induced , Intracranial Hemorrhages/therapy , Male , Plasma , Platelet Transfusion , Pyrazoles/adverse effects , Pyridones/adverse effects , Retrospective Studies , Rivaroxaban/adverse effects
8.
J Emerg Med ; 46(3): 341-4, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24360126

ABSTRACT

BACKGROUND: Transfusion medicine is a common practice in the emergency department (ED) and other outpatient settings, and may be complicated by a low rate of potentially fatal transfusion-related reactions. OBJECTIVES: This article presents a case of transfusion-related acute lung injury (TRALI) diagnosed and treated in the ED and reviews the differential diagnosis of acute transfusion reactions. CASE REPORT: A 74-year-old woman presented to the ED from the hospital's transfusion center with fever and respiratory distress immediately after the start of her second unit of red blood cell transfusion. Chest radiograph demonstrated a pattern consistent with acute respiratory distress syndrome (ARDS). After 48 h of respiratory support and antibiotic therapy, the patient's condition improved. CONCLUSION: TRALI is a clinical diagnosis with presentation similar to that of ARDS. Prompt differentiation from other transfusion reactions and initiation of appropriate treatment is crucial in minimizing the morbidity and mortality associated with this syndrome.


Subject(s)
Acute Lung Injury/etiology , Respiratory Distress Syndrome/etiology , Respiratory Insufficiency/etiology , Transfusion Reaction , Acute Lung Injury/therapy , Aged , Anti-Bacterial Agents/therapeutic use , Female , Fluid Therapy , Humans , Radiography , Respiration, Artificial , Respiratory Distress Syndrome/diagnostic imaging , Respiratory Distress Syndrome/therapy , Respiratory Insufficiency/therapy
9.
J Trauma Acute Care Surg ; 96(6): 944-948, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38523124

ABSTRACT

BACKGROUND: The modified Brain Injury Guidelines (mBIG) were developed to stratify traumatic brain injuries (TBIs) and improve health care utilization by selectively requiring repeat imaging, intensive care unit admission, and neurosurgical (NSG) consultation. The goal of this study is to assess safety and potential resource savings associated with the application of mBIG on interhospital patient transfers for TBI. METHODS: Adult patients with TBI transferred to our Level I trauma center from January 2017 to December 2022 meeting mBIG inclusion criteria were retrospectively stratified into mBIG1, mBIG2, and mBIG3 based on initial clinicoradiological factors. At the time, our institution routinely admitted patients with TBI and intracranial hemorrhage (ICH) to the intensive care unit and obtained a repeat head computed tomography with NSG consultation, independent of TBI severity or changes in neurological examination. The primary outcome was progression of ICH on repeat imaging and/or NSG intervention. Secondary outcomes included length of stay and financial charges. Subgroup analysis on isolated TBI without significant extracranial injury was performed. RESULTS: Over the 6-year study period, 289 patients were classified into mBIG1 (61; 21.1%), mBIG2 (69; 23.9%), and mBIG3 (159; 55.0%). Of mBIG1 patients, 2 (2.9%) had radiological progression to mBIG2 without clinical decline, and none required NSG intervention. Of mBIG2, 2 patients (3.3%) progressed to mBIG3, and both required NSG intervention. More than 35% of transferred patients had minor isolated TBI. For mBIG1 and mBIG2, the median hospitalization charges per patient were $152,296 and $149,550, respectively, and the median length of stay was 4 and 5 days, respectively, with the majority downgraded from the intensive care unit within 48 hours. CONCLUSION: Clinically significant progression of ICH occurred infrequently in 1.5% of patients with mBIG1 and mBIG2 injuries. More than 35% of interfacility transfers for minor isolated TBI meeting mBIG1 and 2 criteria are low value and may potentially be safely deferred in an urban health care setting. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.


Subject(s)
Patient Transfer , Trauma Centers , Humans , Patient Transfer/statistics & numerical data , Patient Transfer/economics , Male , Female , Retrospective Studies , Middle Aged , Adult , Trauma Centers/statistics & numerical data , Length of Stay/statistics & numerical data , Length of Stay/economics , Tomography, X-Ray Computed/statistics & numerical data , Brain Concussion/therapy , Brain Concussion/economics , Intensive Care Units/statistics & numerical data , Intensive Care Units/economics , Practice Guidelines as Topic , Aged
11.
ACG Case Rep J ; 11(1): e01246, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38162005

ABSTRACT

Mushroom (amatoxin) poisoning from ingestion is a rare but life-threatening medical emergency characterized by gastrointestinal symptoms before progression to multisystem organ failure in severe cases. Many therapies of amatoxin intoxication have been described, including supportive care, medical therapies, detoxification strategies, and liver transplant. The evidence supporting these therapies remains limited due to the rarity of amatoxin poisoning and challenge of a timely diagnosis. We report a case of amatoxin poisoning in Los Angeles causing severe liver injury without acute liver failure treated successfully using medical therapies, gallbladder drainage, and plasma exchange.

12.
J Emerg Med ; 44(2): 352-4, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23116933

ABSTRACT

BACKGROUND: Acute calcific tendinitis, a benign and self-limiting inflammatory condition commonly seen in the shoulder, is also described in many other tendons, including those in the hand and wrist. When involving the wrist, acute calcific tendinitis is often misdiagnosed and mistaken for infection. OBJECTIVE: We present this case to increase familiarity with this condition to avoid errors in diagnosis resulting in inappropriate treatment with antibiotics or even surgery. CASE REPORT: A 27-year-old man presented to the Emergency Department with a 2-week history of volar wrist pain, with sudden increase in pain associated with chills and new onset swelling and redness of the wrist. Plain radiographs showed characteristic soft-tissue calcification overlying the insertion of the flexor carpi ulnaris tendon into the wrist. Treatment with ibuprofen and splinting resulted in complete symptom resolution. CONCLUSION: Acute calcific tendinitis is an important consideration in the differential diagnosis of acute wrist pain. Radiographs are helpful in confirming the diagnosis when symptoms and examination findings are characteristic.


Subject(s)
Calcinosis/diagnosis , Tendinopathy/diagnosis , Wrist Joint/physiopathology , Acute Disease , Adult , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Arthralgia/etiology , Calcinosis/physiopathology , Calcinosis/therapy , Chills/etiology , Edema/etiology , Humans , Ibuprofen/therapeutic use , Lymphangitis/diagnosis , Lymphangitis/therapy , Male , Radiography , Splints , Tendinopathy/physiopathology , Tendinopathy/therapy , Wrist Joint/diagnostic imaging
13.
Resuscitation ; 187: 109711, 2023 06.
Article in English | MEDLINE | ID: mdl-36720300

ABSTRACT

BACKGROUND: eCPR, the modality of extracorporeal membrane oxygenation (ECMO) applied in the setting of cardiac arrest, has emerged as a novel therapy which may improve outcomes in select patients with out-of-hospital cardiac arrest (OHCA). To date, implementation has been mainly limited to single academic centres. Our objective is to describe the feasibility and challenges with implementation of a regional protocol for eCPR. METHODS: The Los Angeles County Emergency Medical Services (EMS) Agency implemented a regional eCPR protocol in July 2020, which included coordination across multiple EMS provider agencies and hospitals to route patients with refractory ventricular fibrillation (rVF) OHCA to eCPR-capable centres (ECCs). Data were entered on consecutive patients with rVF with suspected cardiac aetiology into a centralized database including time intervals, field and in-hospital care, survival and neurologic outcome. RESULTS: From July 27, 2020 through July 31, 2022, 35 patients (median age 57 years, 6 (17%) female) were routed to ECCs, of whom 11 (31%) received eCPR and 3 (27%) treated with eCPR survived, all of whom had a full neurologic recovery. Challenges encountered during implementation included cost to EMS provider agencies for training, implementation, and purchase of automatic chest compression devices, maintenance of system awareness, hospital administrative support for staffing and equipment for the ECMO program, and interdepartmental coordination at ECCs. CONCLUSION: We describe the successful implementation of a regional eCPR program with ongoing patient enrolment and data collection. These preliminary findings can serve as a model for other EMS systems who seek to implement regional eCPR programs.


Subject(s)
Cardiopulmonary Resuscitation , Emergency Medical Services , Extracorporeal Membrane Oxygenation , Out-of-Hospital Cardiac Arrest , Humans , Female , Middle Aged , Male , Extracorporeal Membrane Oxygenation/methods , Ventricular Fibrillation/complications , Ventricular Fibrillation/therapy , Cardiopulmonary Resuscitation/methods , Emergency Medical Services/methods , Retrospective Studies
14.
Lancet Respir Med ; 11(9): 791-803, 2023 09.
Article in English | MEDLINE | ID: mdl-37348524

ABSTRACT

BACKGROUND: There is a clinical need for therapeutics for COVID-19 patients with acute hypoxemic respiratory failure whose 60-day mortality remains at 30-50%. Aviptadil, a lung-protective neuropeptide, and remdesivir, a nucleotide prodrug of an adenosine analog, were compared with placebo among patients with COVID-19 acute hypoxaemic respiratory failure. METHODS: TESICO was a randomised trial of aviptadil and remdesivir versus placebo at 28 sites in the USA. Hospitalised adult patients were eligible for the study if they had acute hypoxaemic respiratory failure due to confirmed SARS-CoV-2 infection and were within 4 days of the onset of respiratory failure. Participants could be randomly assigned to both study treatments in a 2 × 2 factorial design or to just one of the agents. Participants were randomly assigned with a web-based application. For each site, randomisation was stratified by disease severity (high-flow nasal oxygen or non-invasive ventilation vs invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]), and four strata were defined by remdesivir and aviptadil eligibility, as follows: (1) eligible for randomisation to aviptadil and remdesivir in the 2 × 2 factorial design; participants were equally randomly assigned (1:1:1:1) to intravenous aviptadil plus remdesivir, aviptadil plus remdesivir matched placebo, aviptadil matched placebo plus remdesvir, or aviptadil placebo plus remdesivir placebo; (2) eligible for randomisation to aviptadil only because remdesivir was started before randomisation; (3) eligible for randomisation to aviptadil only because remdesivir was contraindicated; and (4) eligible for randomisation to remdesivir only because aviptadil was contraindicated. For participants in strata 2-4, randomisation was 1:1 to the active agent or matched placebo. Aviptadil was administered as a daily 12-h infusion for 3 days, targeting 600 pmol/kg on infusion day 1, 1200 pmol/kg on day 2, and 1800 pmol/kg on day 3. Remdesivir was administered as a 200 mg loading dose, followed by 100 mg daily maintenance doses for up to a 10-day total course. For participants assigned to placebo for either agent, matched saline placebo was administered in identical volumes. For both treatment comparisons, the primary outcome, assessed at day 90, was a six-category ordinal outcome: (1) at home (defined as the type of residence before hospitalisation) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalised but either on supplemental oxygen or not at home, (5) hospitalised or in hospice care, or (6) dead. Mortality up to day 90 was a key secondary outcome. The independent data and safety monitoring board recommended stopping the aviptadil trial on May 25, 2022, for futility. On June 9, 2022, the sponsor stopped the trial of remdesivir due to slow enrolment. The trial is registered with ClinicalTrials.gov, NCT04843761. FINDINGS: Between April 21, 2021, and May 24, 2022, we enrolled 473 participants in the study. For the aviptadil comparison, 471 participants were randomly assigned to aviptadil or matched placebo. The modified intention-to-treat population comprised 461 participants who received at least a partial infusion of aviptadil (231 participants) or aviptadil matched placebo (230 participants). For the remdesivir comparison, 87 participants were randomly assigned to remdesivir or matched placebo and all received some infusion of remdesivir (44 participants) or remdesivir matched placebo (43 participants). 85 participants were included in the modified intention-to-treat analyses for both agents (ie, those enrolled in the 2 x 2 factorial). For the aviptadil versus placebo comparison, the median age was 57 years (IQR 46-66), 178 (39%) of 461 participants were female, and 246 (53%) were Black, Hispanic, Asian or other (vs 215 [47%] White participants). 431 (94%) of 461 participants were in an intensive care unit at baseline, with 271 (59%) receiving high-flow nasal oxygen or non-invasive ventiliation, 185 (40%) receiving invasive mechanical ventilation, and five (1%) receiving ECMO. The odds ratio (OR) for being in a better category of the primary efficacy endpoint for aviptadil versus placebo at day 90, from a model stratified by baseline disease severity, was 1·11 (95% CI 0·80-1·55; p=0·54). Up to day 90, 86 participants in the aviptadil group and 83 in the placebo group died. The cumulative percentage who died up to day 90 was 38% in the aviptadil group and 36% in the placebo group (hazard ratio 1·04, 95% CI 0·77-1·41; p=0·78). The primary safety outcome of death, serious adverse events, organ failure, serious infection, or grade 3 or 4 adverse events up to day 5 occurred in 146 (63%) of 231 patients in the aviptadil group compared with 129 (56%) of 230 participants in the placebo group (OR 1·40, 95% CI 0·94-2·08; p=0·10). INTERPRETATION: Among patients with COVID-19-associated acute hypoxaemic respiratory failure, aviptadil did not significantly improve clinical outcomes up to day 90 when compared with placebo. The smaller than planned sample size for the remdesivir trial did not permit definitive conclusions regarding safety or efficacy. FUNDING: National Institutes of Health.


Subject(s)
COVID-19 , Respiratory Insufficiency , Adult , Humans , Female , Middle Aged , Male , COVID-19/complications , SARS-CoV-2 , Treatment Outcome , COVID-19 Drug Treatment , Respiratory Insufficiency/drug therapy , Respiratory Insufficiency/etiology , Oxygen
16.
J Emerg Med ; 42(5): e105-8, 2012 May.
Article in English | MEDLINE | ID: mdl-19443168

ABSTRACT

BACKGROUND: Acute aortic dissection is a life-threatening disease that is often a diagnostic challenge in the Emergency Department (ED). Patients with acute aortic dissection often have underlying hypertension and atherosclerotic disease, and commonly present with acute-onset severe chest or back pain in their sixth or seventh decades of life. Aortic dissection, however, can also be seen in patients < 40 years old and may present chronically, with symptom duration longer than 2 weeks. OBJECTIVE: We present an unusual case of chronic aortic dissection in a young patient, followed by a review of the literature on chronic aortic dissections and aortic dissections in young patients. CASE REPORT: We report a case of chronic aortic dissection in a 32-year-old man with a history of untreated hypertension who presented to the ED with palpitations and mild shortness of breath. CONCLUSION: Acute and chronic thoracic aortic dissections can occur in patients of all ages, as well as in patients with atypical signs and symptoms.


Subject(s)
Aortic Aneurysm, Thoracic/diagnosis , Aortic Dissection/diagnosis , Adult , Chronic Disease , Humans , Male , Treatment Outcome
17.
Am J Clin Pathol ; 158(6): 730-738, 2022 12 01.
Article in English | MEDLINE | ID: mdl-36197906

ABSTRACT

OBJECTIVES: Manufacturer recalls and altered supply chains during the coronavirus disease 2019 (COVID-19) pandemic caused a nationwide shortage of blue-top tubes (BTTs). Most non-point-of-care coagulation tests use these tubes, leaving laboratories and health care facilities in short supply. The Department of Pathology and Laboratory Medicine at Cedars-Sinai Medical Center implemented interventions to conserve supply without sacrificing patient safety. METHODS: In a retrospective quality improvement analysis, we examined coagulation testing and BTT utilization over the 3-month interval during which our interventions were applied. Our study assessed the interventions' effectiveness by evaluating changes in BTT utilization, coagulation testing volume, and patient impact. RESULTS: Average daily use (ADU) of BTT before and after the intervention were 476 and 403, respectively-a 15.2% reduction. Notably, the Emergency Department had a reduction in ADU of 43.3%. Average daily volumes of coagulation assays performed decreased from 949 to 783-a 17.5% reduction. No adverse events from the Pharmacy Department were identified during the study period. CONCLUSIONS: Interventions resulting in significant reductions were in divisions with effective management and supervision. Success in navigating the BTT shortage stemmed from timely announcements, action, and effective communication. Our recommendations established more effective coagulation assay utilization, decreased overall BTT use, and prevented patients with coagulopathic disorders from experiencing adverse consequences.


Subject(s)
COVID-19 , Humans , Retrospective Studies , Blood Coagulation Tests , Pandemics/prevention & control
18.
BMJ Open ; 12(7): e058782, 2022 07 05.
Article in English | MEDLINE | ID: mdl-35790333

ABSTRACT

INTRODUCTION: Opioid analgesics are often used to treat moderate-to-severe acute non-cancer pain; however, there is little high-quality evidence to guide clinician prescribing. An essential element to developing evidence-based guidelines is a better understanding of pain management and pain control among individuals experiencing acute pain for various common diagnoses. METHODS AND ANALYSIS: This multicentre prospective observational study will recruit 1550 opioid-naïve participants with acute pain seen in diverse clinical settings including primary/urgent care, emergency departments and dental clinics. Participants will be followed for 6 months with the aid of a patient-centred health data aggregating platform that consolidates data from study questionnaires, electronic health record data on healthcare services received, prescription fill data from pharmacies, and activity and sleep data from a Fitbit activity tracker. Participants will be enrolled to represent diverse races and ethnicities and pain conditions, as well as geographical diversity. Data analysis will focus on assessing patients' patterns of pain and opioid analgesic use, along with other pain treatments; associations between patient and condition characteristics and patient-centred outcomes including resolution of pain, satisfaction with care and long-term use of opioid analgesics; and descriptive analyses of patient management of leftover opioids. ETHICS AND DISSEMINATION: This study has received approval from IRBs at each site. Results will be made available to participants, funders, the research community and the public. TRIAL REGISTRATION NUMBER: NCT04509115.


Subject(s)
Acute Pain , Analgesics, Opioid , Pain Management , Patient-Centered Care , Acute Pain/drug therapy , Acute Pain/etiology , Analgesics, Opioid/therapeutic use , Emergency Service, Hospital , Humans , Multicenter Studies as Topic , Observational Studies as Topic , Opioid-Related Disorders , Pain Management/methods , Patient-Centered Care/methods , Prospective Studies
19.
Clin Pract Cases Emerg Med ; 5(4): 385-389, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34813425

ABSTRACT

INTRODUCTION: During protests following the death of George Floyd, kinetic impact projectiles (KIP) were used by law enforcement as a method of crowd control. We describe the injuries seen at a single Level 1 trauma center in Los Angeles over a two-day period of protests to add to the collective understanding of the public health ramifications of crowd-control weapons used in the setting of protests. CASE SERIES: We reviewed the emergency department visits of 14 patients who presented to our facility due to injuries sustained from KIPs over a 48-hour period during civil protests after the death of George Floyd. CONCLUSION: Less lethal weapons can cause significant injuries and may not be appropriate for the purposes of crowd control, especially when used outside of established guidelines.

20.
Clin Pract Cases Emerg Med ; 5(3): 1-7, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34437029

ABSTRACT

INTRODUCTION: Post-tonsillectomy hemorrhage is a serious postoperative complication, and its acute management can present a challenge for the emergency provider. Although various strategies have been proposed, guidance on the best approach for management of this condition in the emergency department (ED) setting remains limited. Anecdotal reports of the use of nebulized tranexamic acid (TXA) for management of tonsillar bleeding have emerged over the past two years. Two recently published case reports describe the successful use of nebulized TXA for stabilization of post-tonsillectomy hemorrhage in an adult and a pediatric patient. CASE SERIES: Eight patients who presented to our ED with secondary post-tonsillectomy hemorrhage received nebulized TXA for hemostatic management. The most common TXA dose used was 500 milligrams, and all but one patient received a single dose of the medication in the ED. Hemostatic benefit was observed in six patients, with complete bleeding cessation observed in five cases. Interventions prior to nebulized TXA administration were attempted in three of the six patients and included ice water gargle, direct pressure with TXA-soaked gauze, and nebulized racemic epinephrine. All but one of the patients were taken to the operating room for definitive management after initial stabilization in the ED. CONCLUSION: Nebulized TXA may offer a hemostatic benefit and aid in stabilization of tonsillectomy hemorrhage in the acute care setting, prior to definitive surgical intervention. Consideration of general principles of nebulization and aerosol particle size may be an important factor for drug delivery to the target tissue site.

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