Dengue Clinical Trial
Official title:
Ability of Bedside Ultrasound to Predict Progression of Severity of Disease in Dengue Fever
The purpose of this study is determine the ability of bedide ultrasound performed in the Emergency Department and Outpatient Department can predict the severity of disease during a Dengue Fever outbreak in children, in Siem Reap, Cambodia. Our hypothesis is that the presence of gallbladder wall thickening and/or pleural effusions in children correlates with progression to Dengue hemorrhagic fever and Dengue shock. In addition, we hypothesize that sonographic imaging of pediatric patients presenting to the emergency department with a fever during a Dengue fever outbreak will change management and disposition.
Dengue fever has various levels of severity, from mild disease to severe hemorrhagic
complications and shock. Dengue is endemic world-wide and has been found in the United
States. The mortality from dengue fever can be as high as 15-20%, with nearly 22,000 deaths
annually, most of them children (Reddy, 2013). There is no reliable way to immediately
predict which children presenting with a fever during a Dengue fever outbreak will progress
to more severe disease. Some children with dengue fever will improve with limited clinical
interventions, but others require intensive therapy. Limited healthcare resources in
developing countries make decisions on treatment or disposition difficult as many children
and poor clinical decision increase morbidity and mortality. In more developed countries
such as the United States, early identification of patients with dengue fever has the
potential to identify children who may benefit from early interventions. Identifying those
patients is the first step in exploring early therapies to effect mortality. Previous
research has demonstrated that intrathoracic/ peritoneal fluid and gallbladder wall
thickening is associated with worsening of the clinical prognosis for hospitalized patients
with dengue fever (Michels, 2013). We will explore earlier presentations in the emergency
department and outpatient department.
Our hypothesis is that the presence of gallbladder wall thickening and/or pleural effusions
in children correlates with progression to Dengue hemorrhagic fever and Dengue shock. In
addition, we hypothesize that sonographic imaging of pediatric patients presenting to the
emergency department with a fever during a Dengue fever outbreak will change management and
disposition. Our specific aim is to 1) compare the accuracy of bedside ultrasound detection
of intra-thoracic fluid, peritoneal free fluid, and gallbladder wall thickening and physical
exam versus physical exam alone in diagnosing dengue fever and 2) determine the association
between sonographic features of dengue (intra-thoracic fluid and gallbladder wall
thickening) and clinical outcome in children with dengue fever.
This study is a prospective observational clinical study in the emergency department,
inpatient ward, intensive care unit, and outpatient department of the Angkor Hospital for
Children in Siem Reap, Cambodia. Study subjects will include children 16 years or less, who
present during the annual Dengue Fever outbreak with suspected Dengue fever. Subjects
include children with an acute febrile illness, and two of the following: headache,
retro-orbital pain, myalgias, arthralgia, rash, hemorrhagic manifestations, or plasma
leakage (i.e. shortness of breath, abdominal distention/pain). Clinicians will determine
their clinical suspicion of dengue, intended therapeutic interventions and disposition
following a history and physical exam but before ultrasound imaging. Study personnel will
perform diagnostic bedside ultrasound imaging of the gallbladder and peritoneal and pleural
spaces (FAST exam) and the clinician again determine their clinical suspicion of Dengue,
intended therapeutic interventions and disposition. Patients will be followed to determine
clinical outcome, therapeutic interventions and disposition. The primary endpoint is
progression of disease. The secondary endpoint will be change in clinical care provided in
the emergency department related to ultrasound imaging.
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Time Perspective: Prospective
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