NCT07621848

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
Last Updated

June 2, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

March 23, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Dengue Fever Dengue Hemorrhagic Fever Thrombocytopenia

Outcome Measures

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.

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

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kassala Advanced Diagnostic Center

Kassala, Sudan

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Mohammed Ganim

    National Center for Gastrointestinal And Liver Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2026

First Posted

June 2, 2026

Study Start

July 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

June 2, 2026

Record last verified: 2026-06

Locations