CTRI/2024/10/074683尚未招募不适用
Observational clinical study to determine the hydration status in subjects with fever visiting the out-patient departments (OPD) utilizing point of care (POC) salivary osmolality testing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 410
- 试验地点
- 5
- 主要终点
- Proportion of dehydrated subjects with fever
研究概览
简要总结
Primary:
• To assess the hydration status of subjects with fever
Secondary:
• To assess the degree of dehydration i.e., mild, moderate, or severe in adult subjects
• To assess the correlation of hydration status with body temperature.
• To assess the correlation of hydration status with age, gender, duration of fever
• To assess the correlation of hydration status with subjects’ fluid/electrolyte drink during the illness
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 2 years or older 2) Fever with a digital thermometer per axilla of greater that or equal to 37.5 °C (99.5 °F) 3) Subject confirms they are not pregnant.
排除标准
- •Critical illness requiring immediate hospitalization 2) Concurrent medical condition that, in the investigator’s opinion, may impact salivary flow rate causing xerostomia or sialorrhoea 3) Gastro-intestinal symptoms such as nausea, vomiting, diarrhoea 4) Inability to produce saliva sample 5) Concomitant use of medication that is likely to impact saliva production (e.g., anticholinergics) 6) In the investigator’s opinion the subject is unable to comply with study procedures or has a condition which may impact study outcomes.
结局指标
主要结局
Proportion of dehydrated subjects with fever
时间窗: At single visit only
次要结局
- • Proportion of each degree of dehydration i.e., mild, moderate, or severe in adult subjects(• Correlation of salivary osmolarity with body temperature.)
研究者
Dr Jogesh Mahajan
Lambda Therapeutic Research Limited
研究点 (5)
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