Dengue, Dengue Fever, Dengue Fever With Warning Signs
Conditions
Keywords
Dengue, Hospitalization, Transfusion, Hemorrhagic Fever, Thrombocytopenia, Mexico
Brief summary
This 3-year prospective observational study aims to identify clinical and laboratory risk factors associated with hospitalization in patients with confirmed dengue virus infection. It also seeks to analyze real-world transfusion practices and their outcomes. The study will be conducted in a second-level hospital in northern Mexico and will follow patients from emergency department entry to clinical resolution or hospital discharge.
Detailed description
This study will prospectively follow patients over 3 years to determine the relationship between clinical/laboratory variables and outcomes such as hospitalization and transfusion need. It seeks to improve understanding of real-world decision-making in transfusions for dengue-related thrombocytopenia and refine current hospitalization criteria based on locally observed predictors. Patients will be enrolled consecutively at emergency departments or outpatient clinics with confirmed dengue infection. Clinical data (fever duration, bleeding signs, vomiting, abdominal pain, platelet count, hematocrit) and transfusion records will be collected and analyzed to identify independent predictors using multivariate logistic regression.
Interventions
None listed
Sponsors
Jose Ivan Rodriguez de Molina Serrano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥5 years * Laboratory-confirmed dengue infection (NS1, IgM, or PCR) * First contact at emergency or outpatient services * Informed consent signed by the patient or legal guardian
Exclusion criteria
* Co-infection with other arboviruses or COVID-19 * Pre-existing hematologic or oncologic disease * Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of enrolled patients requiring hospitalization | Time Frame: Within 10 days of symptom onset | The proportion of patients with laboratory-confirmed dengue infection who require hospitalization will be recorded. Hospitalization is defined as admission to the inpatient ward or intensive care unit for ≥24 hours due to dengue-related clinical indications. Unit of Measure: Percentage of participants (%) |
| Clinical and laboratory risk factors associated with hospitalization | Within 10 days of symptom onset | Description: Among patients who are hospitalized, relevant clinical signs (e.g., persistent vomiting, mucosal bleeding, abdominal pain) and laboratory parameters (e.g., platelet count, hematocrit rise, leukopenia) will be analyzed to identify independent predictors for hospitalization using multivariate regression. Unit of Measure: Odds ratio for each factor (as determined by statistical modeling) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients receiving blood product transfusion | Time Frame: Within 14 days | The proportion of participants who receive any blood product transfusion (platelets, red cells, plasma) will be documented. Transfusions must be indicated for dengue-related complications and recorded in the patient file. Unit of Measure: Percentage of participants (%) |
| Criteria for transfusion used by attending physicians | Within 14 days of symptom onset | Documented clinical and laboratory criteria used to justify transfusion (e.g., platelet count \< 20,000/μL with bleeding, hemodynamic instability, or major hemorrhage) will be analyzed descriptively. No interventions will be assigned by the study team. Unit of Measure: Proportion of cases using each transfusion criterion (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| ICU admission or mortality | Time Frame: 30 days | Proportion of patients who require intensive care unit admission or who die during the course of illness will be recorded to characterize disease severity. Unit of Measure: Percentage of participants (%) |
Countries
Mexico
Contacts
Primary ContactJOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, MSc, Ph, Specialist
Outcome results
None listed