Severe Dengue in Critical Care at Villavicencio, Colombia.

February 5, 2026 updated by: Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio

Characteristics of Patients With Severe Dengue Admitted in Critical Care Units at Villavicencio, Colombia. A Retrospective Observational Trial.

Severe dengue is a cause of admission to critical care, especially in pediatric cases, and during epidemic outbreaks. Fluid support is basically the therapy offered, due to a scarcity of antiviral or immunological options to modulate the disease. Dengue is an endemic condition in tropical and subtropical regions as Villavicencio, and local ICUs provide care to the adult and pediatric population from the city and distant surrounding areas. National and international agencies' clinical guidelines have standard recommendations for the therapy of dengue shock syndrome (DSS), but data about performance is not available. Severity, organ dysfunction, hemorrhagic events, and capillary leak are predictors for decease. There are several epidemiological trials about dengue in the region, although publications about the characteristics of patients in ICU are nearly null. Currently, there is enough human resources and technology in ICU to provide an optimal care in cases of severe dengue. There is a need to recognize most appropriate strategies for the treatment of the disease, and their results, to adjust and provide better outcomes.

The aim of the study is to analyze the characteristics of patients with severe dengue admitted to the intensive care unit, to contribute to knowledge and better understanding of the disease in a specific clinical environment.

An observational retrospective study will be designed by the analysis of the ICU database of hospitals from Villavicencio, Colombia, since January to May 2023. The records of patients admitted with a diagnose of severe dengue will be exported to Excel for reviewing and debugging. Demographic information, laboratory results, severity scores, and outcomes will be examined. Categorical variables will be described by frequency and proportion; quantitative variables will be defined in a central and dispersion distribution. Chi-square and Mann-Whitney U test will be used to compare, according to the characteristics of the outcome.

It will be a pioneer study at this region, and it is necessary to determine the characteristics of patients admitted to the intensive care unit, the care provided, and the results of the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dengue is an endemic viral infection in tropical and subtropical regions like Colombia, with epidemic outbreaks every three years, with severity especially in pediatric cases. Clinical symptoms, and signs are the fundamental strategies for the diagnosis, although they are not explicit for the disease, so it can be undetected. No specific antiviral therapy is available yet.

An increase in the vascular permeability is observed in severe cases. Some viral, and individual characteristics are recognized as risk factors for severity. Viral serotype, secondary infection, comorbidities, and individual genetic host factors predispose to a hyperinflammatory stage and increased response to the infection.

About 5% of severe cases have risk of mortality. Early detection of warning signs, hydration and appropriate care is crucial to prevent decease, and severe cases require proper attention in an ICU for monitoring, fluid restoration, and support of organ dysfunction.

Aggressive fluid therapy is proposed by national and international health organisms, based and limited trials. Crystalloids initial boluses and high fluid therapy are recommended to counter capillary leakage. It involves a risk of fluid overload with chances of secondary injury as pulmonary edema, tissue hypoperfusion, and organ disfunction.

Personalized monitoring of fluid therapy is necessary to achieve the goals of therapy, replacing fluid loss, but reducing timely the accumulated balance. ICU admission offers the opportunity to accomplish such a goal by adjusting the clinical practice guidelines to individual and dynamic needs, based in scientific evidence.

Several publications have evaluated strategies of fluid therapy in sepsis and shock, considering four overlapping phases (ROSE): resuscitation; optimization; stabilization; and evacuation. None of the studies have evaluated patients with dengue.

Determining the characteristics of patients admitted to the ICU by severe dengue, will provide essential information of severity, the therapy provided, the type of support delivered, and the outcomes attained. It will improve the knowledge about the accomplishment of clinical practice guidelines and its results.

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Meta Department
      • Villavicencio, Meta Department, Colombia, 50001
        • Hospital Departamental de Villavicencio
      • Villavicencio, Meta Department, Colombia, 50001
        • Clinica Primavera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The participants in the trial are those patients treated in a critical care unit for dengue during the period of study, according to the registers of admission in the institution.

Description

Inclusion Criteria:

  • Patients admitted at a critical care unit with a diagnose of dengue either clinical or by a positive serology or molecular diagnostic methods.

Exclusion Criteria:

  • Patients with a post admission diagnosis different than dengue either clinical or by a negative serology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dengue hemorrhagic fever group 3
Risk factor (severity 3): no diagnostic or therapeutic intervention; the characteristics of participants will be analyzed by demographics, severity, laboratory results, fluids accumulation, and outcomes.
Other: Risk factor: group 3
Severe dengue, no shock. No diagnostic or therapeutic intervention; the characteristics of participants will be analyzed by demographics, severity, laboratory results, fluids accumulation, and outcomes.
DHF group 4 (DSS);
Risk factor (group 4): no diagnostic or therapeutic intervention; the characteristics of participants will be analyzed by demographics, severity, laboratory results, fluids accumulation, and outcomes.
Other: Risk factor: group 4
Dengue shock syndrome. No diagnostic or therapeutic intervention; the characteristics of participants will be analyzed by demographics, severity, laboratory results, fluids accumulation, and outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of deaths
Time Frame: 30-days
Hospital death
30-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of fluid accumulation
Time Frame: 5 days
Daily positive fluid balance
5 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of ICU days
Time Frame: 30 days
Length of ICU stay
30 days
Number of hospital days
Time Frame: 30-days
Length of hospitalization
30-days
Number of participants with mechanical ventilation
Time Frame: 30-days
Need of mechanical ventilation
30-days
Number of days in mechanical ventilation
Time Frame: 30-days
Length of mechanical ventilation
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Departamental de Villavicencio

Collaborators

Cooperative University of Colombia

Investigators

  • Principal Investigator: Norton Perez-Gutierrez, MD, Cooperative University of Colombia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

December 20, 2025

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

July 1, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRIVI_2023_02_DENGUE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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