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临床试验/NCT01185054
NCT01185054已完成2 期

Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 624 人开始时间: 2010年11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
624
试验地点
1
主要终点
Proportion of children experiencing a treatment failure

研究概览

简要总结

The objective of this study is to clarify the current standard of care by determining if Electrolyte Maintenance Solution (EMS) is truly the optimal fluid to be used in low-risk children who present to an Emergency Department (ED) with < 72 hours of vomiting or diarrhea.

详细描述

Gastroenteritis remains a major cause of morbidity amongst Canadian children. The primary treatment focus revolves around the use of Oral Rehydration Therapy (ORT) to treat dehydration and replace intravascular volume. Since diarrheal disease in Canadian children usually results in mild dehydration and minimal sodium losses, the use of low sodium Electrolyte Maintenance Solutions (EMS) has become the standard of care. However, given that North American children infrequently develop severe dehydration, it is unclear if the routine use of EMS is justified. When pediatricians directly dispense EMS, 16 children need to be treated to prevent 1 unscheduled office visit, however the upper bound of the 95% confidence interval is an astounding 508 patients. In addition, EMS is considered by some to be prohibitively expensive, with 15% of pediatricians believing it to be too expensive for their patients to purchase. An additional 40% report that taste is a major barrier to consumption. As a result, oral fluid replenishment is often underutilized and IV rehydration employed instead. Our goal is to provide evidence to guide the selection of the optimal ORT fluids in low-risk children, thus increasing its use, enhancing its success, and reducing the reliance on intravenous rehydration. We hypothesize that the strict adherence to EMS use in low-risk children may actually be counterproductive by resulting in reduced fluid intake and potentially increasing the use of intravenous rehydration.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 60 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •≥3 episodes of vomiting or diarrhea in preceding 24 hours
  • •Duration of illness less than 96 hours
  • •Age 6 - 60 months
  • •Clinical suspicion of acute intestinal infectious process
  • •Weight ≥ 8 kg
  • •Clinical dehydration score < 5
  • •Capillary refill < 2 seconds
  • •Absence of bulging fontanelle
  • •Absence of bilious vomiting
  • •Absence of blood in diarrhea/emesis
  • •Absence of abdominal pain (if present reported as periumbilical in location)
  • •Absence of abdominal distention
  • •Absence of acute disease currently requiring treatment
  • •Absence of co-existing diseases (prematurity, cardiac, renal, neurological, metabolic, endocrine, immunodeficiency, trauma or history of ingestion)

排除标准

  • •Known gastrointestinal diseases (ie. inflammatory bowel disease, celiac) or any other underlying disease process that might place the child at an increased risk of treatment failure.
  • •Age < 6 months
  • •Weight < 8 kg
  • •If premature, corrected gestational age < 30 weeks
  • •Presence of hematochezia
  • •Responsible physician judges the child requires immediate intravenous rehydration
  • •English language is so limited that consent and/or follow-up is not possible.
  • •Non-Ontario resident [Canadian Institute for Health Information (CIHI) follow-up data will not be available]

研究组 & 干预措施

Fluids as Tolerated (FAT) Group

Experimental

The FAT group will receive ½ strength apple juice and will form the experimental group in this study.

干预措施: ½ strength apple juice (Other)

Electrolyte Maintenance Solution (EMS)

Active Comparator

The EMS group will form the control group as solutions such as Pediatric Electrolyte® are routinely recommended for use in children with gastroenteritis.

干预措施: Pediatric Electrolyte (Other)

结局指标

主要结局

Proportion of children experiencing a treatment failure

时间窗: Within 7 days of enrolment

This outcome will be deemed to have occurred if any of the following occur: * Requires an unscheduled visit after the initial encounter * Requires physician evaluation during a follow-up assessment. * Hospitalization or Intravenous Rehydration * Extended Symptomatology * Failure to consume sufficient study fluid during the initial ED visit

次要结局

  • Proportion of Subjects Requiring Hospitalization(7 days)
  • Frequency of diarrhea and vomiting episodes(7 days)
  • Percent Weight Change(72-84 hours after enrolment)
  • Proportion of Subjects Receiving Intravenous Rehydration(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Freedman

Adjunct Scientist

The Hospital for Sick Children

研究点 (1)

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