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
|Condition or disease||Intervention/treatment|
|Dengue Fever||Other: Bedside Ultrasound|
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.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|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|
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:
- Clinical Progression of disease [ Time Frame: 10 days ]Follow up of Patients to determine hospitalization or treatement
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
|Contact: Romolo Gaspari, MD. PhD||508-334-7943||Romolo.Gaspari@umassmemorial.org|
|Angkor Hospital for Children||Recruiting|
|Siem Reap, Cambodia|
|Contact: Romolo Gaspari, MD, PhD 508-334-7943 email@example.com|
|Principal Investigator: Romolo Gaspari, MD, PhD|
|Principal Investigator: Timothy Gleeson, MD|
|Principal Investigator:||Romolo Gaspari, MD PhD||UMass Worcester|