DengueNCT02134652
Ability of Bedside Ultrasound to Predict Progression of Severity of Disease in Dengue Fever
An observational study of Dengue and Disease Progression, run by University of Massachusetts, Worcester at 1 site in Cambodia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- Dengue, Disease Progression
- What is being tested?
- diagnostic bedside ultrasound
- How many people
- 0 participants
- Where
- 1 siteCambodia
- Study dates
- Jan 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
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)
Who may be able to join
- 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
Who cannot join
- Allergic to Ultrasound gel
- Prisoners or wards of the state
- Unstable patients
- Known pleural effusion, ascites, or gallbladder wall thickening.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 worsening of the clinical prognosis for hospitalized patients with dengue fever (Michels, 2013). We will explore earlier presentations in the emergency department and outpatient department.
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. Our specific aim is to 1) compare the accuracy of bedside ultrasound detection of intra-thoracic fluid, peritoneal free fluid, and gallbladder wall thickening and physical exam versus physical exam alone in diagnosing dengue fever and 2) determine the association between sonographic features of dengue (intra-thoracic fluid and gallbladder wall thickening) and clinical outcome in children with dengue fever.
This study is a prospective observational clinical study in the emergency department, inpatient ward, intensive care unit, and outpatient department of the Angkor Hospital for Children in Siem Reap, Cambodia. 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). Clinicians will determine their clinical suspicion of dengue, intended therapeutic interventions and disposition following a history and physical exam but before ultrasound imaging. Study personnel will perform diagnostic bedside ultrasound imaging of the gallbladder and peritoneal and pleural spaces (FAST exam) and the clinician again determine their clinical suspicion of Dengue, intended therapeutic interventions and disposition. Patients will be followed to determine clinical outcome, therapeutic interventions and disposition. The primary endpoint is progression of disease. The secondary endpoint will be change in clinical care provided in the emergency department related to ultrasound imaging.
- Conditions
- Dengue, Disease Progression
- Being tested
- diagnostic bedside ultrasound
- Keywords
- Ultrasonography, World Health
- Medical subject headings
- Dengue, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic bedside ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: diagnostic bedside ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of Disease
Changes in clinical course or progression of disease in patients with Dengue Fever or Dengue Hemorrhagic Fever
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: Unable to conduct study because of political issues in host country.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel D Licciardo, M.D., Principal investigator, University of Massachusetts, WorcesterRomolo Gaspari, M.D., Ph.D., Study chair, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134652
- Sponsor's protocol ID
- EUS-3325
- Status last verified
- Jun 2015
- First submitted
- 29 Apr 2014
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Bedside Ultrasound to Predict Progression of Severity of Disease in Dengue Fever
- ClinicalTrials.gov ID
- NCT02134652
- Acronym / sponsor ID
- EUS-3325
- Conditions
- Dengue, Disease Progression
- Keywords
- Ultrasonography, World Health
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to conduct study because of political issues in host country.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 worsening of the clinical prognosis for hospitalized patients with dengue fever (Michels, 2013). We will explore earlier presentations in the emergency department and outpatient department.
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. Our specific aim is to 1) compare the accuracy of bedside ultrasound detection of intra-thoracic fluid, peritoneal free fluid, and gallbladder wall thickening and physical exam versus physical exam alone in diagnosing dengue fever and 2) determine the association between sonographic features of dengue (intra-thoracic fluid and gallbladder wall thickening) and clinical outcome in children with dengue fever.
This study is a prospective observational clinical study in the emergency department, inpatient ward, intensive care unit, and outpatient department of the Angkor Hospital for Children in Siem Reap, Cambodia. 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). Clinicians will determine their clinical suspicion of dengue, intended therapeutic interventions and disposition following a history and physical exam but before ultrasound imaging. Study personnel will perform diagnostic bedside ultrasound imaging of the gallbladder and peritoneal and pleural spaces (FAST exam) and the clinician again determine their clinical suspicion of Dengue, intended therapeutic interventions and disposition. Patients will be followed to determine clinical outcome, therapeutic interventions and disposition. The primary endpoint is progression of disease. The secondary endpoint will be change in clinical care provided in the emergency department related to ultrasound imaging.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Dengue | – | Other: diagnostic bedside ultrasoundChildren 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. |
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Allergic to Ultrasound gel
- Prisoners or wards of the state
- Unstable patients
- Known pleural effusion, ascites, or gallbladder wall thickening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic bedside ultrasoundPatients 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. | Other | Suspected Dengue |
Primary outcome
Progression of Disease
Time frame: 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.
Changes in clinical course or progression of disease in patients with Dengue Fever or Dengue Hemorrhagic Fever
1 secondary outcome
Clinical Care
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel D Licciardo, M.D. principal investigator
University of Massachusetts, Worcester
Romolo Gaspari, M.D., Ph.D. study chair
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue and Disease Progression, run by University of Massachusetts, Worcester at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of Disease (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.