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临床试验/NCT02729870
NCT02729870撤回不适用

Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

University of Florida0 个研究点开始时间: 2018年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
Beta-hydroxybutyrate will be analyzed between the groups

研究概览

简要总结

Fasting ketoacidosis adds morbidity to children affected by gastrointestinal infections. The investigators investigate oral glucose gel for its effectiveness in rapidly reducing ketoacidosis and for improvements in oral hydration therapy success.

详细描述

More than 1.7 million children with acute gastroenteritis present for emergency department (ED) care annually in the United States. Gastroenteritis treatment regimens have been outlined in guidelines endorsed by the American Academy of Pediatrics, European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN), and Center for Disease Control (CDC). A fundamental principle included in these guidelines is the administration of oral rehydration therapy (ORT) to the vast majority of children with gastroenteritis; however, surveys have shown that a gap exists between guidelines and practice. Fasting ketoacidosis is an increasingly recognized metabolic derangement for children presenting with symptoms suggestive of gastroenteritis and mild to moderate dehydration. Ketoacidosis frequently occurs and likely adds comorbid symptoms of lethargy, vomiting, and malaise. These symptoms likely impair successful oral rehydration interventions. These symptoms may also lead to overestimations of the severity of dehydration. Rapid recognition of ketoacidosis is now possible with point of care testing beta-hydroxybutyrate. This investigation will determine if an oral glucose gel intervention will improve the Point Of Care (POC) beta-hydroxybutyrate from baseline. Secondary outcomes measured will include net fluid volume intake estimates, need for IV hydration, and need for hospitalization.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants with gastroenteritis presenting to UF Health Shands Emergency Department

排除标准

  • hypoglycemic- Blood glucose less than 50 or hyperglycemic- greater than 200

研究组 & 干预措施

Oral Glucose Gel

This group will consist of participants ages 1 - 7. The subject who are less than 3 year of age will receive 7.5 gram oral glucose gel 40% (0.66 oz, 20ml) which will be a one time dose and the subjects who are ages 3-7 will receive 15 gram oral glucose gel (1.3 oz, 40ml) which is a one time dose.

干预措施: Oral Glucose Gel (Drug)

Oral Placebo Gel

The group will consist of participants ages 1 - 7. The subjects who are less than 3 years of age will receive carboxymethylcellulose (2%) oral gel, 20ml which will be a one time dose and the subjects ages 3- 7 will receive carboxymethylcellulose (2%) oral gel, 40ml which will be a one time dose.

干预措施: Placebo (Other)

结局指标

主要结局

Beta-hydroxybutyrate will be analyzed between the groups

时间窗: Change from baseline to 4 hours

Change in beta-hydroxybutyrate will be measured by blood test from -0 hour to 4 hours between the groups.

次要结局

  • Number of subjects Intravenous (IV)-Hydration between the groups(4 hours)
  • The amount of oral fluid intake in milliliters will be measured between the groups(Change from 1 hour to 4 hours)
  • Number of subjects hospitalized between the groups(4 hours)

研究者

申办方类型
Other
责任方
Sponsor

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