Clinical trial NCT05938647: Severe Dengue in Critical Care at Villavicencio, Colombia.
Official title: Characteristics of Patients With Severe Dengue Admitted in Critical Care Units at Villavicencio, Colombia. A Retrospective Observational Trial.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Dengue
Lead sponsor: Hospital Departamental de Villavicencio
Sponsor class: OTHER
Collaborators: name: Cooperative University of Colombia
First posted: 2023-07-10
Enrollment: 50
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of deaths
timeFrame: 30-days
Secondary outcomes:
measure: Amount of fluid accumulation
timeFrame: 5 days
Other outcomes:
measure: Number of ICU days
timeFrame: 30 days
measure: Number of hospital days
timeFrame: 30-days
measure: Number of participants with mechanical ventilation
timeFrame: 30-days
measure: Number of days in mechanical ventilation
timeFrame: 30-days
Locations:
city: Villavicencio
country: Colombia
facility: Clinica Primavera
state: Meta
city: Villavicencio
country: Colombia
facility: Hospital Departamental de Villavicencio
state: Meta
Study officials:
affiliation: Cooperative University of Colombia
name: Norton Perez-Gutierrez, MD
role: PRINCIPAL_INVESTIGATOR
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