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Bedside Ultrasound Predicts Progression of Severity of Disease in Dengue Fever

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ClinicalTrials.gov Identifier: NCT03632486
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
Angkor Hospital for Children
Information provided by (Responsible Party):
Timothy Gleeson, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment
Dengue Fever Other: Bedside Ultrasound

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bedside Ultrasound Predicts Progression of Severity of Disease in Dengue Fever
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2020


Group/Cohort Intervention/treatment
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

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.




Primary Outcome Measures :
  1. Clinical Progression of disease [ Time Frame: 10 days ]
    Follow up of Patients to determine hospitalization or treatement



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632486


Contacts
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Contact: Romolo Gaspari, MD. PhD 508-334-7943 Romolo.Gaspari@umassmemorial.org

Locations
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Cambodia
Angkor Hospital for Children Recruiting
Siem Reap, Cambodia
Contact: Romolo Gaspari, MD, PhD    508-334-7943    romolo.gaspari@umassmemorial.org   
Principal Investigator: Romolo Gaspari, MD, PhD         
Principal Investigator: Timothy Gleeson, MD         
Sponsors and Collaborators
Timothy Gleeson
Angkor Hospital for Children
Investigators
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Principal Investigator: Romolo Gaspari, MD PhD UMass Worcester

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Responsible Party: Timothy Gleeson, Assistant Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03632486     History of Changes
Other Study ID Numbers: H00003325
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Timothy Gleeson, University of Massachusetts, Worcester:
Ultrasound
Dengue

Additional relevant MeSH terms:
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Fever
Dengue
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral