Ability of Bedside Ultrasound to Predict Progression of Severity of Disease in Dengue Fever

NCT02134652 | Withdrawn DMC

• 1 other identifier: EUS-3325
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dengue; Disease Progression

Keywords

Ultrasonography; World Health

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Clinical Care

  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.

Other Outcomes (1)

• Disposition

  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.

Study Arms (1)

Suspected Dengue

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) will all receive a diagnostic bedside ultrasound.

Other: diagnostic bedside ultrasound

Interventions

diagnostic bedside ultrasound OTHER

Patients enrolled in this study will undergo bedside ultrasound during their initial presentation to the emergency department. Ultrasound imaging protocols include the following: * FAST Exam - Standard images will be obtained using the abdominal transducer. Images include the following: 1) sub-xyphoid 2)right upper quadrant (with right thorax) 3)left upper quadrant (with left thorax) and 4) suprapubic * Right Upper Quadrant Exam - Standard images will be obtained using the abdominal transducer. Images include the following: 1) Long axis of the gallbladder 2) Transverse axis of the gallbladder fundus 3) Transverse axis of the gallbladder body and 4) Transverse axis of the gallbladder neck.

Suspected Dengue

Eligibility Criteria

• Age: 3 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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)

You may qualify if:

• Age \>3 months and \<16 years
• Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System)
• Not a prisoner or ward of the state
• Parents able and willing to give consent. Children older then 7 able and willing to give assent

You may not qualify if:

• Allergic to Ultrasound gel
• Prisoners or wards of the state
• Unstable patients
• Known pleural effusion, ascites, or gallbladder wall thickening.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

Angkor Hospital for Children

Siem Reap, Cambodia

Location

MeSH Terms

Conditions

Dengue; Disease Progression

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel D Licciardo, M.D.

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

• Romolo Gaspari, M.D., Ph.D.

  University of Massachusetts, Worcester

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 9, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 11, 2015

Record last verified: 2015-06

Locations

CA (1)