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New Tools for Predicting Capillary Leak Shock During Dengue Fever

NCT ID: NCT04422782

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-14

Study Completion Date

2023-05-14

Brief Summary

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

Detailed Description

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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

Conditions

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Dengue Fever Children Adults

Keywords

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Dengue Dengue fever Children Adults French Guiana Hypovolemic shock Osmolarity Hyponatremia Hypoprotidemia Clinical-biological score Interstitial fluid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm

Single Arm

Group Type OTHER

For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine

Intervention Type OTHER

Interventional research protocol involving the human person category 2 at risk and minimal constraints

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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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

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Regional Development Fund

OTHER

Sponsor Role collaborator

Centre Hospitalier de Cayenne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu NACHER, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier de Cayenne

Locations

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General Hospital of Cayenne

Cayenne, French Guiana, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Felix DJOSSOU, MD

Role: CONTACT

Phone: 0594395040

Email: [email protected]

DRISP General Hospital of Cayenne

Role: CONTACT

Phone: 0594395385

Email: [email protected]

Facility Contacts

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Mathieu Nacher, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28938048 (View on PubMed)

Other Identifiers

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PrediDengue

Identifier Type: -

Identifier Source: org_study_id