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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 16 Years |
Eligibility |
Inclusion Criteria: 1. Age >3 months and <16 years 2. Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) 3. Not a prisoner or ward of the state 4. Parents able and willing to give consent. Children older then 7 able and willing to give assent Exclusion Criteria: 1. Allergic to Ultrasound gel 2. Prisoners or wards of the state 3. Unstable patients 4. Known pleural effusion, ascites, or gallbladder wall thickening. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Cambodia | Angkor Hospital for Children | Siem Reap |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Worcester |
Cambodia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Disposition | Change in disposition related to ultrasound imaging in patients presenting to the emergency department with symptoms of Dengue Fever | Patients will receive an ultrasound in the emergency department or outpatient department. Within 2 hours of study enrollment, the treating physician will be made aware of the test results and will be queried for decision to admit versus discharge. | No |
Primary | Progression of Disease | Changes in clinical course or progression of disease in patients with Dengue Fever or Dengue Hemorrhagic Fever | Patients who are discharged from home will be contacted a maximum of 10 days after discharge to acquire follow up data. Those patients who are admitted to the hospital will monitored for the entirety of their hospital stay, an average of about 2 weeks. | No |
Secondary | Clinical Care | Change in clinical care provided in the emergency department related to ultrasound imaging for patients presenting to the emergency department with symptoms of Dengue Fever. | Patients will receive an ultrasound in the emergency department or outpatient department. Within 2 hours of study enrollment, the treating physician will be made aware of the test results and will be queried for changes in decision making. | No |
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