Bedside Ultrasound Predicts Progression of Severity of Disease in Dengue Fever

NCT03632486 | Completed

• 1 other identifier: H00003325
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dengue; Fever

Keywords

Ultrasound; Dengue

Outcome Measures

Primary Outcomes (1)

• Clinical Progression of disease

  Follow up of Patients to determine hospitalization or treatement

  10 days

Study Arms (1)

Suspected Dengue

Children with fever and two of the following criteria: anorexia and nausea, rash, aches and pains, warning signs, leukopenia, positive tourniquet test will all receive a diagnostic bedside ultrasound.

Other: Bedside Ultrasound

Interventions

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. * Lung ultrasound to assess for pleural effusions and sonographic b lines.

Suspected Dengue

Eligibility Criteria

• Age: Up to 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 outbreak with suspected dengue fever. Subjects include children with fever and two of the following criteria: anorexia and nausea, rash, aches and pains, warning signs, leukopenia, positive tourniquet test.

You may qualify if:

• Fever
• Clinical suspicion of non-severe dengue (with or without warning signs). (WHO 2010 guidelines)
• Not a prisoner or ward of the state
• Parents able and willing to give consent.

You may not qualify if:

• Allergic to US gel
• Known pleural or pericardial effusion
• Unstable vital signs
• Severe dengue

Sponsors & Collaborators

• Timothy Gleeson: lead
• Angkor Hospital for Children: collaborator

Study Sites (1)

Angkor Hospital for Children

Siem Reap, Cambodia

Location

MeSH Terms

Conditions

Dengue; Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Romolo Gaspari, MD PhD

  UMass Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 15, 2018
• Study Start: August 13, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)