New Tools for Predicting Capillary Leak Shock During Dengue Fever (PrediDengue)
Primary Purpose
Dengue Fever, Children, Adults
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine
Sponsored by
About this trial
This is an interventional diagnostic trial for Dengue Fever focused on measuring Dengue, Dengue fever, Children, Adults, French Guiana, Hypovolemic shock, Osmolarity, Hyponatremia, Hypoprotidemia, Clinical-biological score, Interstitial fluid
Eligibility Criteria
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.
Sites / Locations
- General Hospital of CayenneRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
Single Arm
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Predictive value of plasma hypo-osmolarity
Evaluate the predictive value of plasma hypo-osmolarity in the occurrence of shock during dengue
Validation of the clinical-biological prognostic score
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
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
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
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"
Study the association between the factor "Presence of sickle cell disease" and "occurrence of severe dengue"
Full Information
NCT ID
NCT04422782
First Posted
June 5, 2020
Last Updated
December 9, 2020
Sponsor
Centre Hospitalier de Cayenne
Collaborators
European Regional Development Fund
1. Study Identification
Unique Protocol Identification Number
NCT04422782
Brief Title
New Tools for Predicting Capillary Leak Shock During Dengue Fever
Acronym
PrediDengue
Official Title
New Tools for Predicting Capillary Leak Shock During Dengue Fever
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2020 (Actual)
Primary Completion Date
May 14, 2022 (Anticipated)
Study Completion Date
May 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Cayenne
Collaborators
European Regional Development Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Fever, Children, Adults
Keywords
Dengue, Dengue fever, Children, Adults, French Guiana, Hypovolemic shock, Osmolarity, Hyponatremia, Hypoprotidemia, Clinical-biological score, Interstitial fluid
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
342 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
Single Arm
Intervention Type
Other
Intervention Name(s)
For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine
Other Intervention Name(s)
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
Intervention Description
Interventional research protocol involving the human person category 2 at risk and minimal constraints
Primary Outcome Measure Information:
Title
Occurrence of a shock
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Predictive value of plasma hypo-osmolarity
Description
Evaluate the predictive value of plasma hypo-osmolarity in the occurrence of shock during dengue
Time Frame
2 years
Title
Validation of the clinical-biological prognostic score
Description
Prospectively validate the clinical-biological prognostic score (2013 shock score) and, if possible, improve it
Time Frame
2 years
Title
Relationship between the measurements obtained by osmolarity and capillary leakage
Description
Study the relationship between the measurements obtained by osmolarity and capillary leakage measured by pleural effusion
Time Frame
2 years
Title
Evaluation of the sensitivity / specificity and predictive values of osmolarity and capillary leakage
Description
Evaluation of the sensitivity / specificity and predictive values of these measures in relation to the ultrasound objectification of a pleural effusion
Time Frame
2 years
Title
How long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution
Description
Specify how long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution
Time Frame
2 years
Title
Association between the factor "Presence of sickle cell disease" and "occurrence of severe dengue"
Description
Study the association between the factor "Presence of sickle cell disease" and "occurrence of severe dengue"
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felix DJOSSOU, MD
Phone
0594395040
Ext
+594
Email
felix.djossou@ch-cayenne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
DRISP General Hospital of Cayenne
Phone
0594395385
Ext
+594
Email
cicec@ch-cayenne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu NACHER, MD, PhD
Organizational Affiliation
Centre Hospitalier de Cayenne
Official's Role
Study Director
Facility Information:
Facility Name
General Hospital of Cayenne
City
Cayenne
State/Province
French Guiana
ZIP/Postal Code
97306
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Nacher, MD, PhD
Phone
0594395024
Ext
5024
Email
mathieu.nacher@ch-cayenne.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
28938048
Citation
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.
Results Reference
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New Tools for Predicting Capillary Leak Shock During Dengue Fever
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