New Tools for Predicting Capillary Leak Shock During Dengue Fever

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

Detailed 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

Official Title
-----------------
New Tools for Predicting Capillary Leak Shock During Dengue Fever

Conditions
-----------------
Dengue Fever, Children, Adults

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Single Arm | Other: For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine<br>* Interventional research protocol involving the human person category 2 at risk and minimal constraints<br>* Other names: Systematic search for effusion done in a standardized manner with 3 ultrasound incidences: longitudinal medio axillary, longitudinal medio clavicular and transverse views of the right upper quadrant;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a shock | The primary outcome measure will be the occurrence of a shock defined by systolic blood pressure <90 mm Hg in adults and <80 mm Hg in children. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of plasma hypo-osmolarity | Evaluate the predictive value of plasma hypo-osmolarity in the occurrence of shock during dengue | 2 years | 
| Validation of the clinical-biological prognostic score | Prospectively validate the clinical-biological prognostic score (2013 shock score) and, if possible, improve it | 2 years | 
| Relationship between the measurements obtained by osmolarity and capillary leakage | Study the relationship between the measurements obtained by osmolarity and capillary leakage measured by pleural effusion | 2 years | 
| Evaluation of the sensitivity / specificity and predictive values of osmolarity and capillary leakage | Evaluation of the sensitivity / specificity and predictive values of these measures in relation to the ultrasound objectification of a pleural effusion | 2 years | 
| How long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution | Specify how long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution | 2 years | 
| Association between the factor Presence of sickle cell disease and occurrence of severe dengue | Study the association between the factor Presence of sickle cell disease and occurrence of severe dengue | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dengue, Dengue fever, Children, Adults, French Guiana, Hypovolemic shock, Osmolarity, Hyponatremia, Hypoprotidemia, Clinical-biological score, Interstitial fluid