New Tools for Predicting Capillary Leak Shock During Dengue Fever

Children Clinical Trial

— PrediDengue  

Official title:

New Tools for Predicting Capillary Leak Shock During Dengue Fever

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04422782
• Other study ID #: PrediDengue
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2020
• Est. completion date: May 14, 2023

Study information

• Verified date: December 2020
• Source: Centre Hospitalier de Cayenne
• Contact: Felix DJOSSOU, MD
• Phone: 0594395040
• Email: felix.djossou[@]ch-cayenne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 342
• Est. completion date: May 14, 2023
• Est. primary completion date: May 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adults
• Children
• Dengue
• Dengue Fever
• Fever

Intervention

Other:
• For 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

Locations

Country	Name	City	State
France	General Hospital of Cayenne	Cayenne	French Guiana

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier de Cayenne	European Regional Development Fund

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Predictive value of plasma hypo-osmolarity	Evaluate the predictive value of plasma hypo-osmolarity in the occurrence of shock during dengue	2 years
Secondary	Validation of the clinical-biological prognostic score	Prospectively validate the clinical-biological prognostic score (2013 shock score) and, if possible, improve it	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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