Emergency Medicine Research Associates

Active Studies

Developing a Decision Instrument to Guide Selective Abdominal/Pelvic Imaging of Blunt Trauma Patients

(IRB#15-001602)

Background

Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of “occult” injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases. Existing data suggest that a limited number of criteria can reliably identify blunt injury victims who have “no risk” of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies.

Objective

This study seeks to determine whether “low risk” criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients.

Our Role

All blunt trauma victims undergoing computed tomography (CT) of the abdomen/pelvis in the emergency department (ED) will undergo routine clinical evaluations prior to radiographic imaging. Our volunteers will observe and record vitals for each trauma patient. We are also responsible for assuring that ED physicians record the presence or absence of specific clinical findings as well as the presence or absence of abdominal or pelvic injuries.

 

 

Crystalloid Liberal Or Vasopressors Early Resuscitation in Sepsis (CLOVERS)

(IRB#18-000466)

Background

Sepsis is defined as “a life-threatening organ dysfunction caused by a dysregulated host response to infection” (Sepsis-3 Consensus). It is the leading cause of death in U.S. hospitals and has been identified as a condition requiring early and aggressive intervention. As the condition progresses, it may lead to the state of septic shock in which there is a profound and complex derangement of the inflammatory response and cellular metabolism with vasodilation and circulatory collapse. This condition carries a much higher mortality rate. A landmark study led by Dr. Rivers in 2001 showed that Early Goal Directed Therapy (EGDT), which included the use of intravenous fluids and vasopressors to maintain minimum values of specific vital signs related to perfusion (CVP, SvO2, and MAP) led to a significant decrease in mortality. Large amounts of early intravenous (IV) fluid administration (along with early recognition and administration of antibiotics) has continued to be a mainstay in sepsis treatment. Recent trials (ProCESS, ARISE, and ProMISe) have demonstrated that that targeting of similar physiologic endpoints (CVP, SvO2, and MAP) using fluid resuscitation did not lead to a decrease in mortality. It was interesting to note that overall mortality in all arms was lower than in the 2001 study, presumably due to advances in the overall standard of care (including early recognition and aggressive treatment) of sepsis. Additionally, the FEAST trial, limited to pediatric patients, found that children in septic shock who received early IV fluids had a higher 48-hour mortality. Also, the small CLASSIC trial showed that a more conservative fluid approach led to decreased incidence of kidney injury, though mortality remained similar. This has brought into question the benefits of the widespread practice of aggressive fluid in order to maintain the previously studied hemodynamic endpoints. Note: If attempting background research, it should be noted that the definition, classifications, and treatment recommendations for sepsis have gone through three major revisions. Terminology and criteria (such as SIRS, SOFA, and Severe Sepsis) might not be consistent, depending on date of publication. Sepsis-3 is the most current major consensus article : https://jamanetwork.com/journals/jama/articlepdf/2492881/jsc160002.pdf The 2001 Landmark Study: https://www.nejm.org/doi/full/10.1056/NEJMoa010307

Specific Aims

This study aims to determine the impact of a restrictive fluids strategy (vasopressors first f ollowed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in 2,320 patients with sepsis-induced hypotension.

Our Role

Patient screening; assist study team with enrollment and study start up procedures.

 

Diverticulitis Evaluation of Patient Burden, Utilization, and Trajectory

(IRB#16-000599)

Background

Diverticulitis is diagnosed when the small pouches that line the digestive system (called “diverticula”) become inflamed or infected. Symptoms of diverticulitis include moderate to severe abdominal pain, nausea, fever, or chills. When a patient has an episode of diverticulitis, they may be prescribed antibiotics to treat it. Patients who have had several episodes of diverticulitis may consider surgical treatment to remove the affected part of the colon. The perceived burden of diverticulitis on the lives of those who do and do not undergo elective resection and characteristics of those who may report greater impact (e.g., age less than 50) have not been systematically assessed. Addressing these evidence gaps is essential to evaluating the effectiveness of modern diverticulitis care and informing future practice guidelines aimed at more patient-centered care for millions of Americans. The study is important for the development of comparative evaluations of operative and non-operative approaches to diverticulitis and novel non-surgical treatments.

Objective

To better understand the care given to patients who have diverticulitis and their outcomes (whether they have surgery or medical therapy).

Our Role

In this study, our volunteers’ roles span from screening and consenting patients to interviewing patients and completing case report forms.

 

Outpatient Venous Thromboemboelism Management (Outpatient VTE)

(IRB#16-001624)

Background

Venous Thromboembolism (VTE) occurs when a blood clot in a deep vein in the periphery, such as in the leg, groin or arm, also known as deep venous thrombosis (DVT), travels in the circulation and lodges in a pulmonary vessel, known as pulmonary embolism (PE). Until recently, the most common treatment for VTE was the administration of injectable low molecular weight heparin (LMWH) and vitamin K antagonists. However, since the development of oral anticoagulants, such as Apixaban and Rivaroxaban, patients have shown a preference towards this more convenient treatment rather than their injectable counterpart. Regardless of this, physicians are often apprehensive about discharging low-risk patients with VTE, who could be plausibly treated at home with oral anticoagulants, largely due to the lack of a well-founded and standardized system to guarantee their follow up care as well as their full compliance with the treatment plan. As a result, these low-risk patients get unnecessarily admitted and undergo traditional LMWH treatment.

Specific Aims

This work seeks to standardize a protocol which will ameliorate the transition of care of low-risk patients with VTE (including both, PE and DVT) from the emergency department to their homes. The efficacy of this protocol will be assessed by measuring 30-day re-hospitalization rates for patients with VTE receiving outpatient treatment under either one of the following three treatment arms: LMWH, Apixaban, or Rivaroxaban.

Our Role

Patient screening; assist study team with enrollment.

 

Transfusion of Stored Fresh Whole Blood in a Civilian Trauma Center:

A Prospective Evaluation of Feasibility and Outcomes

(IRB#10-001341)

Background

Massive hemorrhage is a major cause of potentially preventable death following trauma. A common consequence of hemorrhagic shock is uncontrollable bleeding from coagulopathy, leading to death from exsanguination. Even when bleeding is controlled, patients are at increased risk of complications and mortality. Reconstituted whole blood, or component therapy with PRBCs, plasma, and platelets was introduced by the military in recent conflicts in Iraq and Afghanistan with remarkable results and has been adopted by most civilian trauma centers. Despite improving coagulopathy, it is apparent that transfusion of blood components is not equivalent to whole blood transfusion. Transfusion of high plasma volumes may be associated with increased risk of allergic reaction, transfusion associated acute lung injury (TRALI), hypervolemic cardiac failure/transfusion-associated circulatory overload (TACO), and ARDS.

Military services that have recently reintroduced fresh whole blood (FWB) for standard resuscitation of massive hemorrhage have found that FWB offers a survival advantage over component therapy, and that risks of transfusion reactions are similar for FWB and component therapy with PRBCs. On the civilian side, whole blood is an FDA-licensed product that has been in use in pediatric open heart surgery and autologous transfusion but is no longer commonly available for other indications. However, the military results are renewing interest in whole blood for trauma resuscitation. Whole blood offers the advantages of more precisely approximating shed blood; decreased volume of additives per transfusion episode; and exposure to a decreased number of donors for a patient undergoing massive transfusion. It remains to be seen whether this will translate into differences in coagulopathy, inflammation, transfusion requirements, and mortality.

Objective

Determine the effectiveness of trauma resuscitation using FWB compared to component therapy and its effects on hospital outcomes including development of coagulopathy, infection, venous thromboembolism (VTE), multiple organ failure (MOF), total transfusion requirements, and mortality.

Our Role

The role of the our volunteers is to be present in trauma bays, operating rooms, and/or ICU as necessary to collect blood samples drawn by hospital personnel. Following each draw, a volunteer will conduct a platelet mapping assay using thromboelastography machines on the blood samples. Finally, the volunteer will fill transport the remainder of the blood sample to the laboratory for further testing.

SDD

Subantimicrobial Dose Doxycycline

Study Goal

Sepsis is the #1 leading cause of death in hospitals. While different treatment modalities have shown promise, they have not always been consistently reliable. The Subantimicrobial Dose Doxycycline (SDD) study explores how patient-specific phenotypic expression and molecular marker levels might influence patient response to specific treatments for septic shock, as well as vasoplegia. SDD will specifically be looking at matrix metalloproteinase 8 (MMP-8) which plays a role in the inflammatory response that contributes to development of sepsis, as well as the effects of low-dose doxycycline on the inhibition of MMP-8 and recovery from septic shock and vasoplegia.

 

 

 

Derivation and Validation of Two Decision Instruments for Selective Chest CT in Blunt Trauma: A Multicenter Prospective Observational Study (NEXUS Chest CT) 10/2015 PLOS
NEXUS Chest Validation of a Decision Instrument for Selective Chest Imaging in Blunt Trauma 10/2013 JAMA Network
External Validation of the San Francisco Syncope Rule 11/2006 Research Gate
A Critical Comparison of Clinical Decision Instruments for Computed Tomographic Scanning in Mild Closed Traumatic Brain Injury in Adolescents and Adults 01/2008 Archive
Developing a Decision Instrument to Guide Computed Tomographic Imaging of Blunt Head Injury Patients 10/2005 The Journal of Trauma: Injury, Infection, and Critical Care
Using Serial Hemoglobin Levels to Detect Occult Blood Loss in the Early Evaluation of Blunt Trauma Patients 9/2017 The Journal of Emergency Medicine
Emergency medicine and psychiatry agreement on diagnosis and disposition of emergency department patients with behavioral emergencies. 04/2011 Link: Pubmed