An interventional study of For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine in Dengue Fever, Children and Adults, sponsored by Centre Hospitalier de Cayenne. Status unknown at 1 site in France. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2020-12-10.
Sponsored by Centre Hospitalier de Cayenne · Not applicable, Interventional, and Diagnostic
Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.
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
279 studies on the registry are indexed under Dengue; 45 are open to participants now.
This study's planned enrollment of 342 is above the median of 123 across 195 interventional studies indexed under Dengue.
Browse Dengue studies →Centre Hospitalier de Cayenne is the lead sponsor of 47 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Time frame: 2 years
Predictive value of plasma hypo-osmolarity
Evaluate the predictive value of plasma hypo-osmolarity in the occurrence of shock during dengue
Time frame: 2 years
Validation of the clinical-biological prognostic score
Prospectively validate the clinical-biological prognostic score (2013 shock score) and, if possible, improve it
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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"
Time frame: 2 years
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier de Cayenne