New Tools for Predicting Capillary Leak Shock During Dengue Fever (PrediDengue)

Centre Hospitalier de Cayenne

Status: Unknown

Conditions: Dengue Fever; Children; Adults

Treatments: Other: For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine

Study type: Interventional

Funder types: Other

Identifiers

NCT04422782

PrediDengue

Details and patient eligibility

About

Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.

Full description

On the South American continent, dengue fever progressively progresses to hyperendemia with co-circulation of different serotypes. Among the complications of dengue fever, a frequent complication is the shock linked to capillary leakage which often occurs at the time of defervescence between the 3rd or 5th day of evolution of the fever. Before that, it is difficult to identify patients who are at risk for severe forms. Patients are therefore seen regularly to monitor for the development of serious forms, which causes saturation of the health system. Despite everything, with each epidemic, the investigators observe deaths of previously healthy people, which always constitutes an important trauma for the population and for the carers. Improving the understanding of the pathophysiology of capillary leakage and the tools to predict it would be significant advances in this common tropical pathology. Thus a retrospective study of longitudinal data during the dengue 2 epidemic of 2013 made it possible to generate precise hypotheses as to the pathophysiology of the shock linked to capillary leakage. Hypoprotidemia and hyponatremia having a strong statistical association with the subsequent occurrence of shock, the hypothesis is of a progressive disturbance of the plasma osmolarity resulting in water leaks towards the interstitial sector.

These preliminary data also made it possible to develop a predictive score which must now be validated over time.

Research involving the human person, monocentric, prospective, validation

Interventional research protocol involving the human person category 2 at risk and minimal constraints

Enrollment: 342 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age> = 5 years
• Patient / parent consent
• Exclude other pathology with capillary circulation problem (septic shock, anaphylaxis) All suspected dengue fever requiring hospitalization will be included, final inclusion being after biological confirmation (AgNS1, RT-PCR, serology).

Exclusion criteria

• Age <5 years
• Refusal to participate
• Unsigned consent
• Coinfection by another agent
• Patient under guardianship or curatorship.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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342 participants in 1 patient group

Single Arm

Other group

Description:

Single Arm

Treatment:

Other: For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine