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CompletedNCT07621848Updated Jun 2, 2026

Abdominal Sonographic Findings and Their Association With Thrombocytopenia in Dengue Fever: A Cross-Sectional Study From an Endemic Region

An observational study in Dengue Fever, sponsored by National Center for Gastroentestinal and Liver Disease. Completed at 1 site in Sudan. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by National Center for Gastroentestinal and Liver Disease · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Sex
All
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Study 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. 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.

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.

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Conditions studied

  • Dengue Fever

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Keywords

  • Dengue Fever Dengue Hemorrhagic Fever Thrombocytopenia
03

In context

Dengue

283 studies on the registry are indexed under Dengue; 44 are open to participants now.

This study's enrollment of 150 is below the median of 595 across 80 observational studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

National Center for Gastroentestinal and Liver Disease is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with laboratory-confirmed dengue infection (NS1 positive)
  • Patients who underwent abdominal ultrasonography during the course of illness
  • Availability of complete clinical, laboratory (including count), and ultrasound data
  • Patients of all age groups and both sexes

Exclusion criteria

Exclusion Criteria:

  • 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, )
  • Poor-quality or non-interpretable ultrasound images
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: At hospital presentation/admission (retrospective data from July 2024 to February 2025).

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Study locations

1 site
  • Kassala Advanced Diagnostic Center
    Kassala, Sudan
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2024 to primary completion in Feb 2025, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2026
First posted
Jun 2, 2026
StartActual
Jul 1, 2024
Primary completionActual
Feb 1, 2025
CompletionActual
Feb 1, 2025
Last update
Jun 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07621848
Lead sponsor
National Center for Gastroentestinal and Liver Disease
Responsible party
Sponsor
First posted
Jun 2, 2026
Start date
Jul 1, 2024
Primary completion
Feb 1, 2025
Completion
Feb 1, 2025
Last update
Jun 2, 2026

Study contacts

Mohammed Ganim
principal investigator · National Center for Gastrointestinal And Liver Diseases

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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