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临床试验/CTRI/2024/06/068373
CTRI/2024/06/068373尚未招募不适用

Epidemiology and outcomes of patients hospitalized with Dengue: Protocol for a prospective public health surveillance study

Apollo Hospitals Educational and Research Foundation2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月15日最近更新:

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:

  1. For patients hospitalized with Dengue, what are the patterns of clinical presentation, illness severity, treatments received, and outcomes?
  2. What are the patient and  treatment-related predictors of hospital mortality for the cohort of severe dengue patients admitted to ICUs?

Objectives:

  1. 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.
  2. 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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Bharath Kumar TV

Apollo Main Hospital

研究点 (2)

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