New Tools for Predicting Capillary Leak Shock During Dengue Fever (PrediDengue)

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

Study Overview

• Status: Recruiting
• Conditions: Children; Dengue Fever; Adults
• Intervention / Treatment: Other: For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine

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 Type: Interventional
• Enrollment (Anticipated): 342
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Felix DJOSSOU, MD; Phone Number: +594 0594395040; Email: felix.djossou@ch-cayenne.fr
• Study Contact Backup: Name: DRISP General Hospital of Cayenne; Phone Number: +594 0594395385; Email: cicec@ch-cayenne.fr

Study Locations

• France
  • French Guiana
    • Cayenne, French Guiana, France, 97306
      • Recruiting
      • General Hospital of Cayenne
      • Contact: Mathieu Nacher, MD, PhD; Phone Number: 5024 0594395024; Email: mathieu.nacher@ch-cayenne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Cayenne
• Collaborators: European Regional Development Fund
• Investigators: Study Director: Mathieu NACHER, MD, PhD, Centre Hospitalier de Cayenne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Anticipated): May 14, 2022
• Study Completion (Anticipated): May 14, 2023

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Children; Adults; Hyponatremia; Dengue; Dengue fever; French Guiana; Hypovolemic shock; Osmolarity; Hypoprotidemia; Clinical-biological score; Interstitial fluid
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Body Temperature Changes; Hemorrhagic Fevers, Viral; Fever; Dengue
• Other Study ID Numbers: PrediDengue

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No