Clinical trial NCT04422782: New Tools for Predicting Capillary Leak Shock During Dengue Fever
Official title: New Tools for Predicting Capillary Leak Shock During Dengue Fever
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dengue Fever
Children
Adults
Keywords: Dengue
Dengue fever
Children
Adults
French Guiana
Hypovolemic shock
Osmolarity
Hyponatremia
Hypoprotidemia
Clinical-biological score
Interstitial fluid
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
First posted: 2020-06-09
Enrollment: 342
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

Primary outcomes:
measure: Occurrence of a shock
timeFrame: 2 years
Secondary outcomes:
measure: Predictive value of plasma hypo-osmolarity
timeFrame: 2 years
measure: Validation of the clinical-biological prognostic score
timeFrame: 2 years
measure: Relationship between the measurements obtained by osmolarity and capillary leakage
timeFrame: 2 years
measure: Evaluation of the sensitivity / specificity and predictive values of osmolarity and capillary leakage
timeFrame: 2 years
measure: How long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution
timeFrame: 2 years
measure: Association between the factor "Presence of sickle cell disease" and "occurrence of severe dengue"
timeFrame: 2 years
Other outcomes:
Locations:
city: Cayenne
country: France
facility: General Hospital of Cayenne
state: French Guiana
Study officials:
affiliation: Centre Hospitalier de Cayenne
name: Mathieu NACHER, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Djossou F, Vesin G, Elenga N, Demar M, Epelboin L, Walter G, Abboud P, Le-Guen T, Rousset D, Moreau B, Mahamat A, Malvy D, Nacher M. A predictive score for hypotension in patients with confirmed dengue fever in Cayenne Hospital, French Guiana. Trans R Soc Trop Med Hyg. 2016 Dec 1;110(12):705-713. doi: 10.1093/trstmh/trx004.