NCT04422782

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2023

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

June 5, 2020

Last Update Submit

December 9, 2020

Conditions

Dengue FeverChildrenAdults

Keywords

DengueDengue feverChildrenAdultsFrench GuianaHypovolemic shockOsmolarityHyponatremiaHypoprotidemiaClinical-biological scoreInterstitial fluid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Predictive value of plasma hypo-osmolarity

    2 years

  • Validation of the clinical-biological prognostic score

    2 years

  • Relationship between the measurements obtained by osmolarity and capillary leakage

    2 years

  • Evaluation of the sensitivity / specificity and predictive values of osmolarity and capillary leakage

    2 years

  • How long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution

    2 years

  • +1 more secondary outcomes

Study Arms (1)

Single Arm

OTHER

Single Arm

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

Interventions

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

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

Also known as: 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
Single Arm

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> = 5 years
  • Patient / parent consent

You may not qualify if:

  • Age \<5 years
  • Refusal to participate
  • Unsigned consent
  • Coinfection by another agent
  • Patient under guardianship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Cayenne

Cayenne, French Guiana, 97306, France

RECRUITING

Related 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.

    PMID: 28938048BACKGROUND

MeSH Terms

Conditions

DengueShockHyponatremia

Interventions

UrinationBlood Specimen Collection

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralPathologic ProcessesPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological PhenomenaReproductive and Urinary Physiological PhenomenaSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Mathieu NACHER, MD, PhD

    Centre Hospitalier de Cayenne

    STUDY DIRECTOR

Central Study Contacts

Felix DJOSSOU, MD

CONTACT

0594395040felix.djossou@ch-cayenne.fr

DRISP General Hospital of Cayenne

CONTACT

0594395385cicec@ch-cayenne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 9, 2020

Study Start

May 14, 2020

Primary Completion

May 14, 2022

Study Completion

May 14, 2023

Last Updated

December 10, 2020

Record last verified: 2020-12

Locations

FR(1)