Adults, Children, Dengue Fever
Conditions
Keywords
Dengue, Dengue fever, Children, Adults, French Guiana, Hypovolemic shock, Osmolarity, Hyponatremia, Hypoprotidemia, Clinical-biological score, Interstitial fluid
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
Interventions
OTHERFor each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine
Interventional research protocol involving the human person category 2 at risk and minimal constraints
Sponsors
European Regional Development Fund
Centre Hospitalier de Cayenne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of a shock | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validation of the clinical-biological prognostic score | 2 years | Prospectively validate the clinical-biological prognostic score (2013 shock score) and, if possible, improve it |
| Relationship between the measurements obtained by osmolarity and capillary leakage | 2 years | Study the relationship between the measurements obtained by osmolarity and capillary leakage measured by pleural effusion |
| Predictive value of plasma hypo-osmolarity | 2 years | Evaluate the predictive value of plasma hypo-osmolarity in the occurrence of shock during dengue |
| How long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution | 2 years | Specify how long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution |
| Association between the factor Presence of sickle cell disease and occurrence of severe dengue | 2 years | Study the association between the factor Presence of sickle cell disease and occurrence of severe dengue |
| Evaluation of the sensitivity / specificity and predictive values of osmolarity and capillary leakage | 2 years | Evaluation of the sensitivity / specificity and predictive values of these measures in relation to the ultrasound objectification of a pleural effusion |
Countries
France
Contacts
Primary ContactFelix DJOSSOU, MD
Backup ContactDRISP General Hospital of Cayenne
Outcome results
None listed