New Tools for Predicting Capillary Leak Shock During Dengue Fever
试验速览
- 阶段
- 不适用
- 入组人数
- 342
- 试验地点
- 2
- 主要终点
- Occurrence of a shock
研究概览
简要总结
Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Age <5 years
- •Refusal to participate
- •Unsigned consent
- •Coinfection by another agent
- •Patient under guardianship or curatorship.
结局指标
主要结局
Occurrence of a shock
时间窗: 2 years
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.
次要结局
- How long before the shock these measures (osmolarity, score) allow to predict an unfavorable evolution(2 years)
- 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)
- Association between the factor "Presence of sickle cell disease" and "occurrence of severe dengue"(2 years)