Introduction of New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Management of Diarrhoeal Diseases - A Phase IV Surveillance Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27,966
- 试验地点
- 2
- 主要终点
- Symptomatic hyponatraemia with clinical features like convulsion or drowsiness or coma.
研究概览
简要总结
For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period.
Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.
详细描述
It will be a Phase IV surveillance study of adverse effects, particularly symptomatic hyponatraemia associated with routine use of hypo-osmolar ORS solution in the treatment of diarrhoea patients of all ages and of any aetiology in a hospital that admits a large number of diarrhoea patients.
Objectives: To monitor symptomatic hyponatraemia over a completed year in a hospital treating a large number of patients with diarrhoea including cholera where all patients will be treated with low osmolarity ORS
Study Design: It will be a phase IV surveillance study of adverse effects, particularly symptomatic hyponatraemia associated with routine use of hypo-osmolar ORS solution in the treatment of diarrhoea patients of all ages and of any aetiology in a hospital that admits a large number of diarrhoea patients. Hypo-osmolar ORS as recommended by WHO is now being routinely used for all patients admitted to a hospital which admits a large number of diarrhoea patients including cholera. The hospital serves a metropolitan city and it's suburbs known to be endemic for cholera.
Hypothesis: We hypothesise that routine use of the recommended hypo-osmolar ORS will not be associated with a significantly incidence rate of symptomatic hyponatraemia.
Study Site and Population: The study will be conducted in the Infectious Diseases Hospital, Beliaghata, Kolkata. This hospital admits diarrhoea patients of all ages including cholera. The hospital has 3 diarrhoea wards, one for adult men, one for adult women and one for children. It is the designated hospital for admitting all clinically suspected cholera patients from greater Calcutta. Of the total diarrhoea admissions during 1995 to 2002, a little over 25% were children under five,
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted with diarrhoea over the study period of 12 months will be eligible for the study, which include men, women and children.
排除标准
- 未提供
结局指标
主要结局
Symptomatic hyponatraemia with clinical features like convulsion or drowsiness or coma.
次要结局
- Unanticipated adverse effect associated with the routine use of hypo-osmolar ORS solution on a large scale