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临床试验/NCT02216708
NCT02216708已完成2 期

Comparison of Rapid and Slow Rehydration of Severely Malnourished Children Suffering From Dehydrating Diarrhoea and Impact on Renal Function and Subsequent Growth of Children

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2011年5月1日最近更新:
适应症
干预措施

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

Experimental

intravenous fluid for rehydration rapidly over 6 hours

干预措施: Rapid dehydration (Other)

receive slow rehydration recommended by WHO (12 hours)

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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