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临床试验/NCT05383404
NCT05383404招募中不适用

Clinical and Laboratory Parameters Associated With Different Degrees of Dehydration Among Children With Diabetic Ketoacidosis

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
measured degree of dehydration

研究概览

简要总结

Diabetic ketoacidosis (DKA) is a common acute complication of type 1 diabetes mellitus (T1DM). DKA is characterized by hyperglycemia, metabolic acidosis, increased levels of ketone bodies in blood and urine. This leads to osmotic diuresis and severe depletion of water and electrolytes from both the intra- and extracellular fluid (ECF) compartments.

Estimation of the degree of dehydration for children admitted with DKA is of great clinical importance. The calculation of the amount of deficit therapy depends on the estimated degree of dehydration. However, the degree of dehydration present during DKA is difficult to be clinically assessed. Hyperosmolality tends to preserve intravascular volume with maintenance of peripheral pulses, blood pressure, and urine output until extreme volume depletion occurs. Metabolic acidosis leads to hyperventilation and dry oral mucosa as well as decreased peripheral vascular resistance and cardiac function . consequently, hyper-osmolality may lead to an underestimation of the degree of dehydration, whereas metabolic acidosis may lead to an overestimation of the degree of dehydration. This makes the physical findings unreliable in this setting.

Several clinical and biochemical markers were suggested to assess and stage the degree of dehydration at hospital admission. The blood urea nitrogen , hematocrit , plasma albumin are useful markers of the degree of ECF contraction.However, Several previous studies demonstrated that there was no agreement between assessed and measured degree of dehydration which is calculated according to change in body weight at admission and after correction of dehydration. there were tendencies to overestimated or underestimate the degree of dehydration between different physicians. The assessment of the magnitude of dehydration in DKA is of major interest and continues to be a subject of research.

This study aims to assess the association between different clinical and laboratory parameters in children with diabetic ketoacidosis and the degree of dehydration at hospital admission among those children.

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 Hour 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with T1DM aged 0-12 years admitted to the pediatric emergency department with DKA criteria (blood glucose level > 200 mg/dl, pH < 7.3, and /or bicarbonate level in blood < 15 mmol/l and positive ketones in urine by dipstick method) will be included.

排除标准

  • Children with DKA who are referred to Sohag university hospital after starting treatment for DKA at another hospital.

结局指标

主要结局

measured degree of dehydration

时间窗: 1year

calculated as percentage of the difference between the weight at disharge from Picu and the weight at admission to the weight at disharge from Picu

次要结局

未报告次要终点

研究者

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

Mohamed Ahmed Ismail

resident doctor at pediatric department at faculty of medicine sohag university hospital

Sohag University

研究点 (1)

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