PI: Peter Hou, MD

NCT Number: NCT06374797

This double blind, randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of Auxora in patients with severe AKI who have associated AHRF. Approximately 150 patients with severe AKI, defined as having developed either stage 2 or 3 AKI at the time of consent, who have associated AHRF will be randomized 1:1 into either the Auxora or placebo group. All patients, including those that are discharged from the hospital to home, or to a skilled nursing facility, or to an extended care facility, will be assessed at Day 90.

PI: Edy Kim, MD, PHD

The aim of DTCC is to develop a database of clinical and biologic information in subjects with critical illness and cardiac arrest of varying etiology, in order to provide information about the biology, outcomes, risk factors, prognostic indicators and response to therapy during a period of critical illness and cardiac arrest. Secondly, it aims to develop a library of tissues (blood cells, plasma, RNA, DNA etc…) with the purpose of performing future analyses of disease pathogenesis and markers of disease progression in subjects with cardiac arrest. 

PI: Nicole Duggan, MD

This study evaluates UltraSight’s AI-guided cardiac ultrasound software for patients in the emergency department (ED) with syncope or transient ischemic attack (TIA). The study would compare images from the current standard of diagnostic imaging in transthoracic echocardiograms (TTE) to the UltraSight software. Current TTEs rely on expert sonographers and cardiologists while novice scanners could perform high quality imaging at patient bedside with Ultrasight. By analyzing if UltraSight’s AI software can detect abnormal findings with similar effectiveness to TTEs, our study aims to optimize resource use and minimize future costs in emergency rooms.

PIs: Margaret Samuels-Kalow, MD, and Regan H. Marsh, MD, MPH

NCT Number: NCT05688982

MOLAR is an NIH-sponsored study that seeks to determine how to best connect adult and pediatric patients with unmet dental needs with social and dental resources after leaving the BWH and BWFH EDs. Participants are randomized to one of three arms in the study, in which they will receive general resources, geographically targeted resources, or will be connected with a Patient Care Navigator to help address their social and dental needs. Participants will self-report their dental health, resource utilization, and ability to schedule dental care appointments through follow-up surveys, which will elucidate the long-term impacts of each intervention.  

PI: Tiffany Glynn, PhD

People who use drugs (PWUD) and belong to other HIV risk groups such as transgender women, men who have sex with men, Black/Latinx/Indigenous people are at significantly high risk for HIV acquisition. Currently, minoritized PWUD do not benefit from existing efficacious HIV prevention efforts due to varying facets such as minority stress, mental health, substance abuse, and structural/social issues. This study tests a pilot “mSYNC”, which can be downloaded directly to a patient’s smartphone and includes eight modules with ability to go through all app content in <50 minutes with modules on health risk behaviors, psychological distress, and connection to services.

PI: Charlotte Goldfine, MD

With this single arm observation trail we are hoping to gain a better understanding of the preferences and experiences of individuals who present to the Emergency Department with alcohol use disorder to better evaluate them during their care. The main study aim is to identify barriers in linkage to treatment, evaluate their preferences and goals for their ED visit, and assess their impressions of and interest in alcohol detoxification programs. Our secondary aim is to assess how those goals, preferences, and ability to access detoxification program impact ED revisit rates. To better understand these factors, we are asking interested participants to consent to a blood draw, urine sample collection, and to fill out a survey questionnaire.

PI: C. Giovanni Traverso MD, PhD and Peter Chai, MD, MMS

NCT Number: NCT05796362

This is an exploratory study to describe the pharmacokinetics of the azithromycin oral and rectal oleogel in humans compared to the reference oral drug to (Zithromax) assess the impact of the novel formulation on bioavailability. The investigators will perform a randomized, balanced, single dose, three-treatment, three-period, crossover oral bioavailability study under fasted conditions to evaluate the safety and tolerability of azithromycin oleogel and compare the bioavailability of the azithromycin oleogel to the reference drug.

PI: Rahul Mahajan, MD, PhD

NCT Number: NCT05948566

In order to test TS23, an antibody against the alpha-2 antiplasmin (a2-AP) in acute ischemic stroke, we partnered with Dr. Mahajan’s research team to identify and consent patients in the emergency room for this drug trial. Patients who are not a candidate for standard of care reperfusion therapies with an NIH Stroke Scale score (NIHSS) ≥ 4 could be eligible and would be randomized to receive the drug or a placebo upon consent. The administration would be 4.5- 24 hours after stroke onset due to the critical time period for stroke treatment. This clinical trial also aims to determine the desirable dose amount for favorable treatment and disability outcomes.

PI: Kei Ouchi, MD, MPH

NCT Number: NCT06378151

This is a randomized controlled trial to understand the feasibility and acceptability of ED clinician-led conversations surrounding goals of care and time-limited trial of life-sustaining therapies. While many older adults with serious illness present to the ED in their last six months of life, many of them do not have advance care planning conversations with their clinicians. Thus, this study presents a novel opportunity to understand how ED clinicians can initiate conversations to better understand patients’ care goals and values.

PI: Guruprasad Jambaulikar, MBBS, MPH

This is a Phase-1, prospective, single-arm, open-label study to evaluate the performance of Clintech Operation and Molecular Biomarker Measurement Device (Lab Clasp) device as compared to venous lactate values from concurrently collected blood samples.

PI: Peter Chai, MD, MMS & Tiffany Glynn, PhD

The aim of this study is to investigate an early screening approach for alcohol-associated liver disease (ALD) among patients with alcohol use disorder (AUD). In this single-arm observational trial, adults who are admitted to the Addiction Recovery Program at Brigham and Women’s Faulkner Hospital who are eligible will be referred to hepatology and tracked through a 30-day medical chart review. The goal of this study is to both link at-risk patients to care while better understanding the barriers and care needs that this patient population faces during detoxification.

PI: Peter Chai, MD, MMS

This is a single-site cross-sectional survey study that involves participants at the ED who have had a sexually transmitted infection (STI) test within the last 6 months. This study aimed to assess the prevalence and severity of various co-occurring psychosocial conditions that enhance the risk for HIV through a survey form. 

PI: Scott Weiner, MD, MPH

This prospective survey and qualitative interview study assessed how patients and emergency department staff perceive screening for social determinants of health (SDoH). The study consisted of surveys of patients, physicians, physician assistants, nurses, and social workers, along with a series of semi-structured interviews of ED staff, including physicians, physician assistants, nurses, and social workers, working in the Massachusetts General Hospital (MGH), Brigham and Women’s Hospital (BWH), and Brigham and Women’s Faulkner Hospital (BWFH) EDs.

PI: Dana Im, MD, MPH, MPHIL

This cross-sectional study assesses the impact of psychiatric occupational therapy (OT) on the symptoms and experiences of patients presenting to the BWH ED for behavioral health emergencies. Psychiatric OT introduces coping skills and sensory modulation strategies using everyday activities with the goal of de-escalating patients and promoting self-management of symptoms that can extend beyond the hospital setting. This study hopes to demonstrate how the introduction of psychiatric OT in the ED can convert boarding time to active treatment time to ultimately promote patient outcomes.

PI: Andrew Goldsmith, MD, MBA and Nicole Duggan, MD

This study hypothesizes that pulmonary congestion (i.e. B-lines) will decrease after diuresis and correlate with other commonly used pulmonary congestion markets (i.e. weights). The goal of this study is to create automatic quantification of total B-lines on point-of-care ultrasound (POCUS) using retrospective lung ultrasound data available. Simultaneously patients are enrolled in the emergency department for observational study by performing a lung POCUS on patients with volume overload both pre and post lung ultrasound.

PI: Scott Weiner, MD, MPH

One aspect of opioid use disorder is cue reactivity, where exposure to drug-related cues can trigger cravings and reinforce behaviors to use drugs. Music can influence mood, reduce anxiety, and change pain thresholds. Listening to music may also attenuate nociceptive processing and change thresholds of pain tolerance. By examining how specific musical stimuli interact with drug-related cues, this study hopes to identify whether music can serve as an adjunctive strategy or an emotional anchor that diminishes cravings associated with opioid cues.

PI: Charlotte Goldfine, MD

The DOTS project is an FDA funded surveillance study that involves participants presenting with severe or life-threatening opioid, stimulant, and/or undifferentiated illicit substance overdoses to Emergency Departments across the United States. The study aligns with the FDA’s mission to learn more about missed opportunities for prevention, effective treatment of drug overdose, and targeted interventions of those groups that are at the highest risk of being affected by this crisis. Investigators will collect data via a structured patient interview, chart review of clinical information, and blood sample collection. The data will be utilized to gain a comprehensive understanding of current drug use and overdose, as well as to inform future regulatory activities and public health messaging.

PIs: DaMarcus Baymon, MD, and Jong Woo Lee, MD, PhD

Using Targeted Temperature Management, this clinical trial aims to determine the ideal cooling duration to promote neurological recovery for adult comatose survivors of cardiac arrest. Participants are rapidly cooled to <34°C using a definitive temperature control device and are randomized to undergo 12, 24, or 48 hours of cooling. Assessment of neurological outcomes and patient recovery will elucidate the shortest cooling duration that can provide maximum treatment outcomes, as well as if these results vary between cardiac arrest presentations with shockable versus non-shockable rhythms.

PIs: Joji Suzuki, MD, and Peter Chai, MD, MMS

NCT Number: NCT05661669

STARK-ED is a pilot double-blind clinical trial that aims to assess the safety and tolerability of ketamine for patients with severe Alcohol Use Disorder presenting to the BWFH ED for inpatient detoxification admission to the Addiction Recovery Program. Participants are randomized to receive a single-dose ketamine infusion or a saline placebo. This study will follow participants for 12 months to monitor the long-term safety of ketamine administration for AUD and to elucidate the preliminary efficacy of ketamine for alcohol-related outcomes, including abstinence, engagement with outpatient treatment, and other behavioral changes.  

PIs: Joji Suzuki, MD, and Peter Chai, MD, MMS

NCT Number: NCT06111339

 The risk of suicides among individuals with opioid use disorder (OUD) is six times the general population, and estimates are that 20-30% of all opioid-related overdose deaths may in fact be suicides. Many of these patients experience structural barriers like poor linkage to care for addiction and psychiatric treatment or do not receive medications for OUD in the ED. This is a pilot, double-blind, placebo-controlled randomized clinical trial of individuals with OUD with suicidal ideation in the emergency department (ED) to investigate the safety and efficacy of either a single infusion of ketamine or saline placebo.

PIs: Charlotte Goldfine, MD, and Peter Chai, MD, MMS

This semi-structured qualitative interview study explores the perceptions of various digital health interventions among adult patients with alcohol use disorder (AUD). These technologies include a digital pill system (DPS): an ingestible sensor measuring medication adherence; wearable alcohol sensors: a patch or device that measures real-time alcohol levels via sweat; and smartphone apps that track risk behavior or connect patients with resources. Interviews with 30 patients admitted to the Addiction Recovery Program (ARP) and Brigham and Women’s Faulkner Hospital (BWFH) provides investigates perceptions towards digital health technologies for AUD treatment, explores the most beneficial aspects, and examines the behaviors each intervention may motivate among individuals with AUD.

PI: Peter Hou, MD

This is a CDC-sponsored public health surveillance study to assess the effectiveness of the SARS-CoV-2 vaccine boosters among healthcare personnel at BWH. This study is also being conducted at 18 other U.S. hospitals. Through review of self-reported surveys, along with participants’ vaccination, testing, and healthcare utilization records, this project aims to elucidate how SARS-CoV-2 vaccination can reduce COVID-19 infection, duration, and severity. 

PIs: Michael Filbin, MD, MSc, and Peter Hou, MD

This study assesses the performance of a whole genome sequencing centered diagnostic approach, compared to standard blood culture, using blood samples from patients with or suspected to have bacteremia, fungemia, or sepsis. Current assays depend on a positive blood culture to initially isolate pathogenic bacteria. This approach takes at least 12-36 hours. To accelerate this process, the company Day Zero Diagnostics (DZD) developed an approach using whole genome sequencing (WGS) and machine learning to rapidly identify circulating organisms and predict antibiotic resistance based on genomic data. By offering identification and antimicrobial resistance (AMR) profiling within hours of presentation instead of days, these methods hold the promise to improve the care of bacteremic patients.

PI: Nicole Duggan, MD

Opioids are commonly used in the treatment of sciatica, a radicular pain radiating down the buttocks along the sciatic nerve. However, the long-term potential for misuse and abuse drastically decreased their utility outside of the ED.  This study is a randomized, placebo-controlled trial investigating the use of a trans-gluteal sciatic nerve block (TGSNB) in the ED for patients with unilateral radiculopathy in the L4-S3 distribution. The TBSNB procedure is widely used by anesthesiologists both post-operatively and for chronic pain. 

PI: Christopher Baugh, MD, MBA

This study is evaluating the clinical utility of Alere NT-proBNP for Alinity I system assay as an aid in the diagnosis and assessment of severity of individuals suspected or having heart failure.