Children Clinical Trial
— PrediDengueOfficial title:
New Tools for Predicting Capillary Leak Shock During Dengue Fever
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 |
Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.
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. |
Country | Name | City | State |
---|---|---|---|
France | General Hospital of Cayenne | Cayenne | French Guiana |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier de Cayenne | European Regional Development Fund |
France,
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
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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