Comparison of Rapid and Slow Rehydration of Severely Malnourished Children Suffering From Dehydrating Diarrhoea and Impact on Renal Function and Subsequent Growth of Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Incidence of over- hydration
研究概览
简要总结
The recommendation for correction of dehydration of severely malnourished children with diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example, in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart failure. There is not enough evidence to convince some of the physicians dealing with severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid rehydration per se is associated with increased incidence of over hydration and heart failure. And whether this approach is applicable in the management of severely malnourished children with severe cholera, which usually require rapid correction of water and electrolyte deficits for prevention of deaths due to hypovolaemic shock and other complications, has not been studied carefully. Recently, we have demonstrated that rapid intravenous rehydration (within 4 to 6 hours) of severely malnourished children with dehydrating cholera replacing appropriate amount of fluid was found to be safe. We feel that rapid rehydration would help in improving the renal function, acidosis and thus improve appetite and reduce ORS failure subsequently. Since our study was uncontrolled, so we have planned a randomised controlled study with adequate sample of 250 participants; 125 will be rehydrated slowly (over 10 to 12 hours) following WHO guideline and 125 patients will be rehydrated with intravenous fluid over 6 hours. Children of either gender, age 6 to 60 months, severely malnourished (Wt for length <-3 Z score of WHO growth chart or with nutritional oedema) with a history of watery of <24 hours with signs severe dehydration attending the ICDDRB Dhaka hospital will be asked to participate in this study. After the parents'/Legal guardian's consent, the children will be transferred to the study ward and will be treated according to the protocol. All children will receive similar treatment except the mode of rehydration, different for the two groups. The children will be closely monitored throughout the study period. The primary outcomes incidence of over hydration and ORS failure and secondary outcomes improvement of renal function and improvement of appetite measured by the food intake will be compared between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 36 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of acute watery diarrhoea of <24 hours.
- •Either sex.
- •Severe dehydration according to WHO guidelines
- •Wt for length/wt for age < -3 SD of WHO growth standard with or without oedema.(malnutrition)
- •Consent given by the parents or legal guardian
排除标准
- •Bloody diarrhoea.
- •Severe infection (e.g. severe pneumonia, clinical sepsis, septic shock, meningitis).
- •Those who received antibiotics/antimicrobial for the current illness
研究组 & 干预措施
intravenous fluid for rehydration rapidly over 6 hours
intravenous fluid for rehydration rapidly over 6 hours
干预措施: Rapid dehydration (Other)
receive slow rehydration recommended by WHO (12 hours)
receive intravenous fluid followed by ORS (slow rehydration recommended by WHO) over 12 hours
干预措施: Slow rehydration (Other)
结局指标
主要结局
Incidence of over- hydration
时间窗: 7 days
Proportion of patient with ORS failure/ requirement of unscheduled IV therapy
时间窗: 7 days
次要结局
- Proportion of patient with acidosis and increased serum creatinine after 24 hours(7 days)
