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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04422782
Other study ID # PrediDengue
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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