Bedside Ultrasound Predicts Progression of Severity of Disease in Dengue Fever



Status:Not yet recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 16
Updated:8/17/2018
Start Date:August 13, 2018
End Date:October 1, 2020
Contact:Romolo Gaspari, MD. PhD
Email:Romolo.Gaspari@umassmemorial.org
Phone:508-334-7943

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The purpose of this study is determine the ability of bedside 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, pulmonary edema/effusions, ascites, pericardial
effusion in children correlates with progression to more severe disease.

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 more severe disease for hospitalized patients with dengue (Michels, 2013).
The investigators will explore earlier presentations to the emergency department and
outpatient department.

The study hypothesis is that the presence of early sonographic findings in children
correlates with progression to more severe disease. The study specific aim is to determine
the association between sonographic features of dengue and disease progression and clinical
outcome in children with dengue fever.

This study is a prospective observational clinical study in the emergency department of the
Angkor Hospital for Children in Siem Reap, Cambodia. Study subjects will include children 16
years or less, who present during a dengue outbreak with suspected dengue. Subjects include
children with an acute febrile illness and criteria for dengue based on 2010 WHO guidelines
(fever and two of the following criteria: anorexia and nausea, rash, aches and pains, warning
signs, leukopenia, positive tourniquet test). Clinicians will determine their clinical
suspicion of dengue, intended therapeutic interventions and disposition following a history
and physical exam. Study personnel will perform diagnostic bedside ultrasound imaging of the
gallbladder, peritoneal, cardiac, and pleural spaces. Patients will be followed to determine
clinical outcome, therapeutic interventions and disposition. The primary endpoint is
progression of disease.

Inclusion Criteria:

1. Fever

2. Clinical suspicion of non-severe dengue (with or without warning signs). (WHO 2010
guidelines)

3. Not a prisoner or ward of the state

4. Parents able and willing to give consent.

Exclusion Criteria:

- Allergic to US gel

- Known pleural or pericardial effusion

- Unstable vital signs

- Severe dengue
We found this trial at
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Worcester, Massachusetts 01655
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Worcester, MA
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