Dengue FeverNCT07621848
Abdominal Sonographic Findings and Their Association With Thrombocytopenia in Dengue Fever: A Cross-Sectional Study From an Endemic Region
An observational study of Dengue Fever, run by National Center for Gastroentestinal and Liver Disease at 1 site in Sudan.
Trial summary
Dengue fever is a common mosquito-borne viral infection in many tropical regions, including Sudan. Some patients develop severe forms of the disease, such as dengue hemorrhagic fever, which can lead to plasma leakage, bleeding, organ involvement, and life-threatening complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dengue Fever
- How many people
- 150 participants
- Where
- 1 siteSudan
- Study dates
- 1 Jul 2024to 1 Feb 2025
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consisted of patients with confirmed dengue infection who presented to healthcare facilities in Kassala, Sudan, between July 2024 and February 2025. All included patients had undergone abdominal ultrasonography as part of their clinical evaluation. Demographic, clinical, laboratory, and imaging data were retrospectively collected and analyzed to assess the relationship between ultrasound findings and disease severity.
Who may be able to join
- Patients with laboratory-confirmed dengue infection (NS1 positive)
- Patients who underwent abdominal ultrasonography during the course of illness
- Availability of complete clinical, laboratory (including platelet count), and ultrasound data
- Patients of all age groups and both sexes
Who cannot join
- Patients without confirmed dengue diagnosis
- Patients with incomplete or missing clinical, laboratory, or ultrasound records
- Patients with pre-existing hepatic, hematologic, or abdominal conditions that may affect ultrasound findings (e.g., chronic liver disease, malignancy)
- Poor-quality or non-interpretable ultrasound images
Trial locations and contacts
1 site in 1 country.
About this study
Dengue fever is a common mosquito-borne viral infection in many tropical regions, including Sudan. Some patients develop severe forms of the disease, such as dengue hemorrhagic fever, which can lead to plasma leakage, bleeding, organ involvement, and life-threatening complications. Early identification of patients at risk of severe disease is essential for timely management and improved outcomes.
This study aims to describe the abdominal ultrasound findings in patients diagnosed with dengue fever and to examine how these findings relate to clinical features and blood test results, particularly low platelet counts (thrombocytopenia). Ultrasound is a non-invasive and widely available imaging method that may help detect complications early and guide clinical decision-making.
Read more
In this retrospective cross-sectional study, medical records and archived abdominal ultrasound images of 150 patients with laboratory-confirmed dengue infection were reviewed. The study evaluated the frequency of findings such as gallbladder wall thickening, fluid accumulation in the abdomen and chest, liver and spleen enlargement, and rare complications like internal bleeding. These imaging findings were then compared with patient demographics and laboratory results to determine their clinical significance.
By identifying the most common ultrasound features and their association with disease severity, this study seeks to support the use of abdominal ultrasound as a practical tool for risk assessment and monitoring in dengue-endemic settings. The results may help clinicians recognize severe dengue earlier and improve patient management in resource-limited environments.
Read the detailed description
Dengue fever is a major public health concern in endemic regions, with a wide clinical spectrum ranging from mild illness to severe dengue hemorrhagic fever characterized by plasma leakage, bleeding, and organ involvement. Early identification of patients at risk of progression to severe disease remains a clinical challenge, particularly in resource-limited settings where advanced diagnostic tools may not be readily available.
Abdominal ultrasonography has emerged as a useful, non-invasive imaging modality for detecting early signs of plasma leakage and organ involvement in dengue infection. Findings such as gallbladder wall thickening, ascites, pleural effusion, hepatomegaly, and splenomegaly have been reported to correlate with disease severity. However, data on the utility of these sonographic features in Sudanese populations remain limited.
This study was designed as a retrospective cross-sectional analysis conducted in Kassala, Sudan, covering the period from July 2024 to February 2025. It utilized archived abdominal ultrasound images and corresponding clinical and laboratory data of patients with NS1-confirmed dengue infection. The study focused on systematically evaluating predefined sonographic parameters and examining their relationship with hematological indicators, particularly platelet count as a marker of disease severity.
Statistical analysis was performed to determine the strength of associations between imaging findings and clinical severity indicators. Special attention was given to identifying imaging patterns that may serve as early predictors of severe disease, as well as documenting less common but clinically significant complications.
The findings of this study are intended to contribute to the existing body of evidence supporting the role of abdominal ultrasound in dengue management. By clarifying its prognostic value, the study aims to inform clinical practice and encourage the incorporation of ultrasound into routine assessment and risk stratification protocols in dengue-endemic and resource-constrained settings.
- Conditions
- Dengue Fever
- Keywords
- Dengue Fever Dengue Hemorrhagic Fever Thrombocytopenia
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dengue Patients with Abdominal Ultrasound | This cohort includes patients with laboratory-confirmed dengue infection (NS1 positive) who underwent abdominal ultrasonography during their illness. Clinical data, hematologic parameters (including platelet counts), and archived ultrasound findings were retrospectively reviewed to assess the association between sonographic features and disease severity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Platelet Count and Abdominal Ultrasonographic Findings in Patients With Dengue Infection
Correlation between platelet count (cells/µL), measured by complete blood count at hospital presentation, and the presence of abdominal ultrasonographic findings including gallbladder wall thickening (mm), ascites (present/absent), and hepatomegaly (present/absent), assessed by abdominal ultrasound at hospital presentation.
Measured: At hospital presentation/admission (retrospective data from July 2024 to February 2025).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jul 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Center for Gastroentestinal and Liver Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed Ganim, Principal investigator, National Center for Gastrointestinal And Liver Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621848
- Sponsor's protocol ID
- DengueFeverUS
- Status last verified
- Jun 2026
- First submitted
- 23 Mar 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Sonographic Findings and Their Association With Thrombocytopenia in Dengue Fever: A Cross-Sectional Study From an Endemic Region
- ClinicalTrials.gov ID
- NCT07621848
- Acronym / sponsor ID
- DengueFeverUS
- Conditions
- Dengue Fever
- Keywords
- Dengue Fever Dengue Hemorrhagic Fever Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Center for Gastroentestinal and Liver DiseaseUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 2 Jun 2026 (actual)
- 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.
Dengue fever is a common mosquito-borne viral infection in many tropical regions, including Sudan. Some patients develop severe forms of the disease, such as dengue hemorrhagic fever, which can lead to plasma leakage, bleeding, organ involvement, and life-threatening complications. Early identification of patients at risk of severe disease is essential for timely management and improved outcomes.
This study aims to describe the abdominal ultrasound findings in patients diagnosed with dengue fever and to examine how these findings relate to clinical features and blood test results, particularly low platelet counts (thrombocytopenia). Ultrasound is a non-invasive and widely available imaging method that may help detect complications early and guide clinical decision-making.
In this retrospective cross-sectional study, medical records and archived abdominal ultrasound images of 150 patients with laboratory-confirmed dengue infection were reviewed. The study evaluated the frequency of findings such as gallbladder wall thickening, fluid accumulation in the abdomen and chest, liver and spleen enlargement, and rare complications like internal bleeding. These imaging findings were then compared with patient demographics and laboratory results to determine their clinical significance.
By identifying the most common ultrasound features and their association with disease severity, this study seeks to support the use of abdominal ultrasound as a practical tool for risk assessment and monitoring in dengue-endemic settings. The results may help clinicians recognize severe dengue earlier and improve patient management in resource-limited environments.
Detailed description
Dengue fever is a major public health concern in endemic regions, with a wide clinical spectrum ranging from mild illness to severe dengue hemorrhagic fever characterized by plasma leakage, bleeding, and organ involvement. Early identification of patients at risk of progression to severe disease remains a clinical challenge, particularly in resource-limited settings where advanced diagnostic tools may not be readily available.
Abdominal ultrasonography has emerged as a useful, non-invasive imaging modality for detecting early signs of plasma leakage and organ involvement in dengue infection. Findings such as gallbladder wall thickening, ascites, pleural effusion, hepatomegaly, and splenomegaly have been reported to correlate with disease severity. However, data on the utility of these sonographic features in Sudanese populations remain limited.
This study was designed as a retrospective cross-sectional analysis conducted in Kassala, Sudan, covering the period from July 2024 to February 2025. It utilized archived abdominal ultrasound images and corresponding clinical and laboratory data of patients with NS1-confirmed dengue infection. The study focused on systematically evaluating predefined sonographic parameters and examining their relationship with hematological indicators, particularly platelet count as a marker of disease severity.
Statistical analysis was performed to determine the strength of associations between imaging findings and clinical severity indicators. Special attention was given to identifying imaging patterns that may serve as early predictors of severe disease, as well as documenting less common but clinically significant complications.
The findings of this study are intended to contribute to the existing body of evidence supporting the role of abdominal ultrasound in dengue management. By clarifying its prognostic value, the study aims to inform clinical practice and encourage the incorporation of ultrasound into routine assessment and risk stratification protocols in dengue-endemic and resource-constrained settings.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dengue Patients with Abdominal Ultrasound | – | –This cohort includes patients with laboratory-confirmed dengue infection (NS1 positive) who underwent abdominal ultrasonography during their illness. Clinical data, hematologic parameters (including platelet counts), and archived ultrasound findings were retrospectively reviewed to assess the association between sonographic features and disease severity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consisted of patients with confirmed dengue infection who presented to healthcare facilities in Kassala, Sudan, between July 2024 and February 2025. All included patients had undergone abdominal ultrasonography as part of their clinical evaluation. Demographic, clinical, laboratory, and imaging data were retrospectively collected and analyzed to assess the relationship between ultrasound findings and disease severity.
Key inclusion criteria (4 listed)
- Patients with laboratory-confirmed dengue infection (NS1 positive)
- Patients who underwent abdominal ultrasonography during the course of illness
- Availability of complete clinical, laboratory (including platelet count), and ultrasound data
- Patients of all age groups and both sexes
Key exclusion criteria (4 listed)
- Patients without confirmed dengue diagnosis
- Patients with incomplete or missing clinical, laboratory, or ultrasound records
- Patients with pre-existing hepatic, hematologic, or abdominal conditions that may affect ultrasound findings (e.g., chronic liver disease, malignancy)
- Poor-quality or non-interpretable ultrasound images
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Between Platelet Count and Abdominal Ultrasonographic Findings in Patients With Dengue Infection
Time frame: At hospital presentation/admission (retrospective data from July 2024 to February 2025).
Correlation between platelet count (cells/µL), measured by complete blood count at hospital presentation, and the presence of abdominal ultrasonographic findings including gallbladder wall thickening (mm), ascites (present/absent), and hepatomegaly (present/absent), assessed by abdominal ultrasound at hospital presentation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed Ganim principal investigator
National Center for Gastrointestinal And Liver Diseases
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 Fever, run by National Center for Gastroentestinal and Liver Disease at 1 site in Sudan.
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: finished, as of the sponsor's last update on 2 Jun 2026. 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 Sudan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation Between Platelet Count and Abdominal Ultrasonographic Findings in Patients With Dengue Infection (time frame: At hospital presentation/admission (retrospective data from July 2024 to February 2025).). 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 2 Jun 2026.