Epidemiology and outcomes of patients hospitalized with Dengue: Protocol for a prospective public health surveillance study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Survival of intensive care unit stay
研究概览
简要总结
Research questions:
- For patients hospitalized with Dengue, what are the patterns of clinical presentation, illness severity, treatments received, and outcomes?
- What are the patient and treatment-related predictors of hospital mortality for the cohort of severe dengue patients admitted to ICUs?
Objectives:
- To describe the clinical presentation, demographics, including socio-economic determinants, illness severity, biochemical and hematological abnormalities, treatments received (fluids, vasopressors, organ support strategies, antiviral and anti-inflammatory medications) and outcomes for all dengue patients admitted to participating hospitals and ICUs over a 6-month period.
- To evaluate treatment-related predictors of mortality for the cohort of severe dengue patients admitted to ICUs using modern causal inference approaches.
Methods and Measurements:
Study design: Prospective public health surveillance protocol
Inclusion criteria: Patients diagnosed with suspected or confirmed dengue (based on laboratory confirmation or per WHO or respective Ministry of Health diagnostic criteria). and admitted to a participating hospital.
Exclusion criteria: The only exclusion criteria would be lack of informed consent in jurisdictions that mandate the need for consent.
Outcome measures:
Our aim is to describe the clinical presentation (duration of illness, symptoms), demographics including socio-economic determinants, co-morbidities, illness severity (clinical, biochemical, laboratory, need for organ support), treatments received (IV fluids [type, volume, duration], blood and blood product transfusions, organ support provided during hospital stay, experimental therapies [corticosteroids, plasma exchange, IV immunoglobulins etc.], and outcomes [survival, ICU and hospital length of stay). Where feasible, we will also collect information on viral serotype/genotype. We will also evaluate treatment-related predictors of survival for the cohort of severe dengue patients using modern causal inference methods such as target trial emulation with a specific focus on steroids, plasma exchange and IVIg.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients diagnosed with suspected or confirmed dengue (based on laboratory confirmation or per WHO or respective Ministry of Health diagnostic criteria).
- •and admitted to a participating hospital.
排除标准
- •lack of informed consent.
结局指标
主要结局
Survival of intensive care unit stay
时间窗: ICU discharge
次要结局
- hospital survival, need for organ support(at the time of ICU & hospital discharge)
研究者
Bharath Kumar TV
Apollo Main Hospital
