PrediDengue: New Tools for Predicting Capillary Leak Shock During Dengue Fever

Sponsor

Centre Hospitalier de Cayenne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04422782

Collaborator

European Regional Development Fund (Other)

342

Enrollment

Location

Arm

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dengue Fever Children Adults	Other: For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

342 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

New Tools for Predicting Capillary Leak Shock During Dengue Fever

Actual Study Start Date :

May 14, 2020

Anticipated Primary Completion Date :

May 14, 2022

Anticipated Study Completion Date :

May 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Arm Single Arm	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 Other Names: Collection of biological samples : Aliquot of remnants of urine and blood for possible ancillary studies on prognostic factors for occurrence of shock due to capillary leakage during dengue Systematic search for effusion done in a standardized manner with 3 ultrasound incidences: longitudinal medio axillary, longitudinal medio clavicular and transverse views of the right upper quadrant

Arm

Intervention/Treatment

Other: Single Arm

Single Arm

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

Other Names:

Collection of biological samples : Aliquot of remnants of urine and blood for possible ancillary studies on prognostic factors for occurrence of shock due to capillary leakage during dengue

Systematic search for effusion done in a standardized manner with 3 ultrasound incidences: longitudinal medio axillary, longitudinal medio clavicular and transverse views of the right upper quadrant

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Predictive value of plasma hypo-osmolarity [2 years]
Evaluate the predictive value of plasma hypo-osmolarity in the occurrence of shock during dengue
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
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
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"

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).