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临床试验/NCT02249845
NCT02249845Unknown不适用

Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
108
试验地点
1
主要终点
WHO scale evaluation

研究概览

简要总结

The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale, Gorelick scale) among small children.

详细描述

The eligible patient admitted to the hospital with acute diarrhea, after given written consent for participation in the study by the child's parents, will be clinically assessed. Dehydration syndromes noted by physician will be recorded in special form (in attachment). Than, the child will be weighted on a standard scale.

The next body mass evaluation will take place, when patient's clinical condition will by classified as good by the attending physician and the child will be at least 24 hours after finishing intravenous or probe rehydration therapy.

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 Month 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age: 1 - 36 months for CDS scale; 1 month - 5 years old for WHO scale and Gorelick scale
  • hospitalisation caused by acute diarrhea (acute diarrhea -increase in the frequency of evacuations ≥ 3 in 24 hours; with or without fever or vomiting)
  • duration of symptoms under 5 days
  • parents' written consent for child's participation in the study

排除标准

  • Dehydration caused by other mechanisms than acute diarrhea, for example dehydration caused by:
  • kidney failure
  • heart failure
  • chronic liver disease
  • respiratory failure
  • condition after surgery

结局指标

主要结局

WHO scale evaluation

时间窗: all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)

sensitivity, specificity, positive and negative likelihood ratios for WHO scale for dehydration \<5%, 5-10%, \>10%

CDS scale evaluation

时间窗: all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)

sensitivity, specificity, positive and negative likelihood ratios for CDS scale for dehydration \<3%, 3-6%, \>6%

Gorelick scale evaluation

时间窗: when all data will be collectedall necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)

sensitivity, specificity, positive and negative likelihood ratios for Gorelick scale for dehydration ≥5%, ≥10%

次要结局

未报告次要终点

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Piotr Dziechciarz, MD

Medical Doctor

Medical University of Warsaw

研究点 (1)

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